Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 258
- 试验地点
- 55
- 主要终点
- Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
研究概览
简要总结
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine.
The study will focus on 5 autoimmune diseases in adults:
- Systemic Lupus Erythematosus (SLE)
- Rheumatoid Arthritis (RA)
- Multiple Sclerosis (MS)
- Systemic Sclerosis (SSc), and
- Pemphigus.
This study will focus on 4 autoimmune diseases in pediatric participants:
- Systemic Lupus Erythematosus (SLE)
- Juvenile Idiopathic Arthritis (JIA)
- Pediatric-Onset Multiple Sclerosis (POMS)
- Juvenile Dermatomyositis (JDM)
详细描述
Adult Population:
Stage 1 of this trial will enroll up to a maximum of 900 adult study participants (up to 60 participants per arm).
Participants will be assigned to one of 3 cohorts based on their IS regimens:
- Cohort A: Receipt of MMF or MPA
- Cohort B: Receipt of MTX
- Cohort C: Receipt of any BCDT within the past 18 months.
Treatment Arms: Participants in Cohorts A, B, and C will be assigned to receive an additional dose of the same COVID-19 vaccine as their original vaccine series. The trial initially enrolled participants who were vaccinated with the Pfizer-BioNTech COVID-19 Vaccine, the Moderna COVID-19 Vaccine, and the Janssen COVID-19 Vaccine. Update: Arms to receive an additional homologous vaccine dose after an initial Janssen COVID 19 Vaccine were closed to enrollment after the CDC updated its recommendations to express a clinical preference for individuals to receive an mRNA COVID-19 vaccine over the Janssen COVID-19 vaccine. All Adult Stage 1 treatment arms were closed to enrollment on 15 August 2022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Adult Inclusion Criteria:
- •1. Willing and able to sign informed consent
- •Documented full COVID-19 vaccination (CDC card or documentation in medical records) that was completed at least 4 weeks prior and no more than 52 weeks prior to the Stage 1 Screening visit, or if participating in Stage 2, no more than 48 weeks prior to the Stage 2 Screening visit.
排除标准
- •History of severe allergic reaction to the initial COVID-19 vaccine regimen, to any component of any of the COVID-19 vaccines, or to polyethylene glycol (PEG).
- •3. New diagnosis of malignancy that will require chemotherapy or immunotherapy, or ongoing treatment for a malignancy with chemotherapy or immunotherapy.
- •4. Active disease (per the Investigator's decision) resulting in inability to hold the IS therapy in the MMF/MPA or MTX arms of the study.
- •a. The potential impact of temporarily holding medication for participants with a recent mild disease flare within 4 weeks should be carefully considered.
- •5. Active disease during the Screening period resulting in:
- •An increase/addition of any IS medications, or
- •A suggestion of MS relapse per the investigator.
- •Recent or current SARS-CoV-2 infection defined as:
- •Documented SARS-CoV-2 infection in the past 30 days (from the day the participant is diagnosed by positive test to Screening).
- •Positive result on a molecular COVID-19 test at Screening.
- •Inflammatory myocarditis/pericarditis within 6 weeks of any COVID-19 vaccine doses.
- •9. Participants with active, ongoing chronic infections. Note: Participants are permitted to be on chronic prophylactic antimicrobial therapy. Adults with evidence of HIV, Hepatitis B indicated by surface antigen, and Hepatitis C indicated by anti-hepatitis C antibody positivity will be excluded. If an adult is negative for Hepatitis C viral load at Screening, he/she will be eligible to participate.
- •10. Participants with common variable immunodeficiency disease, as well as any participants currently receiving immune globulin replacement therapy. Note: Pediatric participants on IVIG therapeutically may enter the study provided they have sufficiently quiet disease that they can withhold their IVIG from 8 weeks prior to the Screening visit through 4 weeks after vaccination.
- •11. Participants who received licensed or investigational monoclonal antibodies or plasma products directed against SARS-CoV-2 within 30 days of Screening.
- •12. Participants who have received any live vaccines within 2 months of the anticipated study vaccine dose or who will have need of a live vaccine at any time during the study.
- •13. Currently pregnant or breastfeeding (For pediatric participants postmenarchal females must have a negative urine pregnancy test at Screening).
- •15. Hemoglobin (Hgb) <8.0 g/dL (80 g/L)
- •Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
- •17. Other investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of Screening.
- •18. Concurrent treatment with cyclophosphamide. Adult participants taking cladribine, alemtuzumab, or mitoxantrone will also be excluded.
- •19. Participants currently on any type of dialysis, or who have received a solid organ transplant.
- •20. Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
- •21. Taking both MMF/MPA and MTX.
- •Receiving other investigational BCDT as part of a clinical trial within 18 months of Screening, unless drug assignment is known and the participant received an anti-CD20 or CD19 drug.
- •23. Participants with active systemic infections who have received systemic antimicrobials within the 14 days prior to Screening.
- •Adult General Criteria
- •Inclusion Criteria:
- •Individuals 18 years of age or older that meet classification criteria for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), rheumatoid arthritis (RA), multiple sclerosis (MS), or pemphigus
- •Participants must meet the 2019 ACR/EULAR or 2012 SLICC classification criteria for SLE, the 2010 ACR/EULAR classification criteria for RA, the 2013 EULAR/ACR classification criteria for SSc, the 2017 McDonald criteria for MS, and the international consensus criteria for pemphigus.
- •If a participant has been diagnosed with more than one autoimmune disease, the participant will be assessed based on the disease that is selected for study entry
- •Must be currently taking one of the following IS medications with or without additional disease-related medications: MMF (minimum of 1000 mg per day)/MPA (minimum of 720 mg per day), MTX (minimum of 7.5mg per week), or B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, ofatumumab).
- •If taking MMF/MPA or MTX, the participant must have initiated therapy at least 8 weeks prior to randomization and be taking the same medications (regardless of dose) as at the time of the initial COVID-19 vaccine regimen. Note: Participants who withheld their IS medications around their initial vaccinations are eligible to participate.
- •If enrolling in the BCDT cohort, the participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months.
- •7. No changes in background IS medications, including MMF/MPA or MTX, in the 4 weeks prior to Screening, excluding the following:
- •Intraarticular steroids,
- •The addition of prednisone at ≤10mg per day or prednisone at any dose when given for ≤3 days, and
- •Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or COPD, are permitted.
- •Adult General Exclusion Criterion
- •Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- •14. Adult female participants who are planning a pregnancy during the course of the trial.
- •Adult Stage 1-Specific Inclusion Criterion
- •Negative or suboptimal serologic response to initial COVID-19 vaccine regimen, defined as an Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL, at Screening visit.
- •Initial COVID-19 vaccine regimen is defined as either:
- •i.2 doses of the Pfizer-BioNTech COVID-19 Vaccine ii. 2 doses of the Moderna COVID-19 Vaccine
- •Adult Stage 1-Specific Exclusion Criterion
- •Receipt of a COVID-19 vaccine booster prior to Screening with the Moderna COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, or Janssen COVID-19 Vaccine.
- •Adult Stage 2 (Newly Recruited)-Specific Inclusion Criteria
- •History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG.
- •5. Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:
- •3 doses of the Pfizer-BioNTech COVID-19 Vaccine
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研究组 & 干预措施
Cohort A, Arm A2: BNT162b2 + Continue IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: BNT162b2 (Biological)
Cohort A, Arm A3: Ad26.COV2.S + Continue IS (MMF or MPA)
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Ad26.COV2.S (Biological)
Cohort A, Arm A5: BNT162b2 + Withhold IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: BNT162b2 (Biological)
Cohort A, Arm A6: Ad26.COV2.S + Withhold IS (MMF or MPA)
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
干预措施: Ad26.COV2.S (Biological)
Cohort B, Arm B2: BNT162b2 + Continue IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: BNT162b2 (Biological)
Cohort B, Arm B3: Ad26.COV2.S + Continue IS (MTX)
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Ad26.COV2.S (Biological)
Cohort B, Arm B5: BNT162b2 + Withhold IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
干预措施: BNT162b2 (Biological)
Cohort B, Arm B6: Ad26.COV2.S + Withhold IS (MTX)
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
干预措施: Ad26.COV2.S (Biological)
Cohort C, Arm C2: BNT162b2 + Continue IS (B cell depletion therapy)
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: BNT162b2 (Biological)
Cohort C, Arm C3: Ad26.COV2.S + Continue IS (B cell depletion therapy)
Arm closed, effective protocol version 3.0. Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Ad26.COV2.S (Biological)
Cohort D, Arm D1: Ad26.COV2.S + Withhold IS (MMF or MPA)
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
干预措施: Ad26.COV2.S (Biological)
Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: BNT162b2 (Biological)
Cohort E, Arm E1: Ad26.COV2.S + Withhold IS (MTX)
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
干预措施: Ad26.COV2.S (Biological)
Cohort F, Arm F1: Ad26.COV2.S + Withhold IS (B cell depletion therapy)
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
干预措施: Ad26.COV2.S (Biological)
Cohort B, Arm B2: BNT162b2 + Continue IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MTX) (Drug)
Cohort F, Arm F4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (B cell depletion therapy)
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction
干预措施: Withhold IS (B cell depletion therapy) (Drug)
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Moderna mRNA-1273 (Biological)
Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MMF or MPA) (Drug)
Cohort A, Arm A2: BNT162b2 + Continue IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MMF or MPA) (Drug)
Cohort A, Arm A3: Ad26.COV2.S + Continue IS (MMF or MPA)
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MMF or MPA) (Drug)
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Moderna mRNA-1273 (Biological)
Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort A, Arm A5: BNT162b2 + Withhold IS (MMF or MPA)
Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort A, Arm A6: Ad26.COV2.S + Withhold IS (MMF or MPA)
Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Moderna mRNA-1273 (Biological)
Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MTX) (Drug)
Cohort B, Arm B3: Ad26.COV2.S + Continue IS (MTX)
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MTX) (Drug)
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Adult Participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Moderna mRNA-1273 (Biological)
Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
Adult Participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort B, Arm B5: BNT162b2 + Withhold IS (MTX)
Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort B, Arm B6: Ad26.COV2.S + Withhold IS (MTX)
Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (B cell depletion therapy)
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Moderna mRNA-1273 (Biological)
Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (B cell depletion therapy)
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (B cell depletion therapy) (Biological)
Cohort C, Arm C2: BNT162b2 + Continue IS (B cell depletion therapy)
Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (B cell depletion therapy) (Biological)
Cohort C, Arm C3: Ad26.COV2.S + Continue IS (B cell depletion therapy)
Arm closed, effective protocol version 3.0. Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (B cell depletion therapy) (Biological)
Cohort D, Arm D1: Ad26.COV2.S + Withhold IS (MMF or MPA)
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: BNT162b2, Bivalent (Biological)
Cohort D, Arm D3: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort D, Arm D3: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort E, Arm E1: Ad26.COV2.S + Withhold IS (MTX)
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort E, Arm E2: Alternative mRNA Vaccine + Withhold IS (MTX)
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Withhold IS (MTX) (Drug)
Cohort E, Arm E2: Alternative mRNA Vaccine + Withhold IS (MTX)
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort E, Arm E2: Alternative mRNA Vaccine + Withhold IS (MTX)
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: BNT162b2, Bivalent (Biological)
Cohort A, Arm A2P: BNT162b2, Bivalent + Continue IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: BNT162b2, Bivalent (Biological)
Cohort E, Arm E3: Moderna mRNA-1273 + Withhold IS (MTX)
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Withhold IS (MTX) (Drug)
Cohort E, Arm E3: Moderna mRNA-1273 + Withhold IS (MTX)
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort F, Arm F1: Ad26.COV2.S + Withhold IS (B cell depletion therapy)
Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (B cell depletion therapy) (Drug)
Cohort F, Arm F2: Alternative mRNA Vaccine + Withhold IS (B cell depletion therapy)
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Withhold IS (B cell depletion therapy) (Drug)
Cohort F, Arm F2: Alternative mRNA Vaccine + Withhold IS (B cell depletion therapy)
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort F, Arm F2: Alternative mRNA Vaccine + Withhold IS (B cell depletion therapy)
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: BNT162b2, Bivalent (Biological)
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (B cell depletion therapy)
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Withhold IS (B cell depletion therapy) (Drug)
Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (B cell depletion therapy)
Adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort D, Arm D4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
干预措施: Monovalent [B.1.351] CoV2 preS dTM-AS03 (Biological)
Cohort D, Arm D4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MMF or MPA)
Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort E, Arm E4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MTX)
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
干预措施: Monovalent [B.1.351] CoV2 preS dTM-AS03 (Biological)
Cohort E, Arm E4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MTX)
Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort F, Arm F4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (B cell depletion therapy)
Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction
干预措施: Monovalent [B.1.351] CoV2 preS dTM-AS03 (Biological)
Cohort A, Arm A1P: Moderna mRNA-1273, Bivalent + Continue IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MMF or MPA) (Drug)
Cohort A, Arm A1P: Moderna mRNA-1273, Bivalent + Continue IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort A, Arm A2P: BNT162b2, Bivalent + Continue IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MMF or MPA) (Drug)
Cohort A, Arm A4P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort A, Arm A4P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort A, Arm A5P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort A, Arm A5P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: BNT162b2, Bivalent (Biological)
Cohort B, Arm B1P: Moderna mRNA-1273, Bivalent + Continue IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MTX) (Drug)
Cohort B, Arm B1P: Moderna mRNA-1273, Bivalent + Continue IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort B, Arm B2P: BNT162b2, Bivalent + Continue IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (MTX) (Drug)
Cohort B, Arm B2P: BNT162b2, Bivalent + Continue IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: BNT162b2, Bivalent (Biological)
Cohort B, Arm B4P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort B, Arm B4P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort B, Arm B5P: BNT162b2, Bivalent + Withhold IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort B, Arm B5P: BNT162b2, Bivalent + Withhold IS (MTX)
Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.
干预措施: BNT162b2, Bivalent (Biological)
Cohort C, Arm C1P: Moderna mRNA-1273, Bivalent + Continue IS (B cell depletion therapy)
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (B cell depletion therapy) (Biological)
Cohort C, Arm C1P: Moderna mRNA-1273, Bivalent + Continue IS (B cell depletion therapy)
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort C, Arm C2P: BNT162b2, Bivalent + Continue IS (B cell depletion therapy)
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: Continue IS (B cell depletion therapy) (Biological)
Cohort C, Arm C2P: BNT162b2, Bivalent + Continue IS (B cell depletion therapy)
Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.
干预措施: BNT162b2, Bivalent (Biological)
Cohort D, Arm D1P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort D, Arm D1P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: BNT162b2, Bivalent (Biological)
Cohort D, Arm D2P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MMF or MPA) (Drug)
Cohort D, Arm D2P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort E, Arm E1P: BNT162b2, Bivalent + Withhold IS (MTX)
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort E, Arm E1P: BNT162b2, Bivalent + Withhold IS (MTX)
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: BNT162b2, Bivalent (Biological)
Cohort E, Arm E2P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (MTX) (Drug)
Cohort E, Arm E2P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
Cohort F, Arm F1P: BNT162b2, Bivalent + Withhold IS (B cell depletion therapy)
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (B cell depletion therapy) (Drug)
Cohort F, Arm F1P: BNT162b2, Bivalent + Withhold IS (B cell depletion therapy)
Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.
干预措施: BNT162b2, Bivalent (Biological)
Cohort F, Arm F2P: Moderna mRNA-1273, Bivalent + Withhold IS (B cell depletion therapy)
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Withhold IS (B cell depletion therapy) (Drug)
Cohort F, Arm F2P: Moderna mRNA-1273, Bivalent + Withhold IS (B cell depletion therapy)
Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
干预措施: Moderna mRNA-1273, Bivalent (Biological)
结局指标
主要结局
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
时间窗: Week 4 Status Post Receipt of COVID-19 Vaccination
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4
时间窗: Week 4 Status Post Receipt of COVID-19 Vaccination
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4
时间窗: Week 4 Status Post Receipt of COVID-19 Vaccination
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
次要结局
- Change in Stage 1 Adult Anti-COVID-19 Antibody Response(Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination)
- Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples(Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination)
- Percentage of Stage 1 Adult Participants Who Seroconverted(Week 4 Status Post Receipt of COVID-19 Vaccination)
- Percentage of Stage 2 Adult Participants Who Seroconverted(Week 4 Status Post Receipt of COVID-19 Vaccination)
- Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels(Week 4 Status Post Receipt of COVID-19 Vaccination)
- Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels(Week 4 Status Post Receipt of COVID-19 Vaccination)
- Change in Stage 2 Adult Anti-COVID-19 Antibody Response(Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination)
- Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples(Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination)
- Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)(Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose)
- Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)(Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose)
- Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS(Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS(Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10)(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)(Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose)
- Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)(Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose)
- Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine(Up to Week 48 post study vaccination)
- Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine(Up to Week 48 post study vaccination)
- Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs)(Up to Week 48 post study vaccination)
- Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs)(Up to Week 48 post study vaccination)
- Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)(Up to Week 48 post study vaccination)
- Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)(Up to Week 48 post study vaccination)
- Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)(Up to Week 48 post study vaccination)
- Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)(Up to Week 48 post study vaccination)
- Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection(Up to Week 48 post study vaccination)
- Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection(Up to Week 48 post study vaccination)
- Percentage of Stage 2 Pediatric Participants Who Seroconverted(Week 4 Status Post Receipt of COVID-19 Vaccination)
- Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels(Week 4 Status Post Receipt of COVID-19 Vaccination)
- Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response(Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination)
- Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples(Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination)
- Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)(Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose)
- Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment(Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose)
- Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)(Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose)
- Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine(Up to Week 48 post study vaccination)
- Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs)(Up to Week 48 post study vaccination)
- Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs)(Up to Week 48 post study vaccination)
- Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)(Up to Week 48 post study vaccination)
- Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection(Up to Week 48 post study vaccination)