NCT05518487已完成2 期
Safety and Immunogenicity of a Dose of the Sanofi-GSK Monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 Vaccine in Kidney Transplant Recipients With a Persistently Low SARS CoV-2 Antibody Titer (COVID19-TB-04)
National Institute of Allergy and Infectious Diseases (NIAID)6 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年2月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL
研究概览
简要总结
An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have ≤2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate..
The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer >2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide informed consent
- •Individual ≥ 18 years of age.
- •Recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment
- •Maintenance immunosuppressive regimen consisting of CNI and mycophenolate mofetil or mycophenolate, with or without ≤ 5mg/day prednisone or equivalent
- •Received completed primary series (3 doses) of mRNA vaccine (either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) as specified in the respective package inserts
- •Receipt a COVID-19 bivalent mRNA booster (Moderna or Pfizer-BioNTech) >30 days prior to enrollment.
- •Serum antibody titer up to 2500 U/mL at ≥ 30 days from the last dose of mRNA COVID-19 vaccine and
- •30 days following receipt of a monoclonal antibody product or convalescent plasma for COVID-19, measured using the Roche Elecsys(R) anti-SARS-CoV-2 S assay
- •Platelet count greater than 30,000/cu mm must be confirmed in participants with a known history of bleeding disorder or thrombocytopenia (platelet count <50,000/cu mm)
- •A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence for 12 weeks post vaccine and while taking mycophenolate mofetil/mycophenolic acid
排除标准
- •Recipient of any number of doses of any COVID vaccine product other than the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine
- •Recipient of any organ other than a kidney
- •Known current or prior Donor Specific Antibody (DSA)
- •Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
- •Known diagnosis of COVID-19 since last antibody test
- •Receipt of a monoclonal antibody product or convalescent plasma within the last 30 days
- •Known history of hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. (components listed in Section 6, and the CoV2 and AS03 Investigator's Brochure)
- •Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating intramuscular (IM) vaccination based on Investigator's judgment
- •Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- •Receipt of any vaccine in the 30 days preceding the study vaccine or planned vaccines in the 30 days following the study vaccine
- •Estimated Glomerular Filtration Rate <30mL/min/1.73m^2
- •Receipt of any cellular depleting agent (e.g. Antithymocyte globulin (ATG), Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
- •Receiving systemic immunomodulatory medication(s) for any condition other than transplant
- •Any uncontrolled active infection
- •Infection with human immunodeficiency virus (HIV)
- •Maintenance immunosuppressive regimen that includes anything other than a CNI, mycophenolate/mycophenolate mofetil, and ≤ 5mg/day prednisone or equivalent
- •Recent (within one year) or ongoing treatment for malignancy, except for definitive surgical treatment of localized skin cancers
- •Any unstable acute or chronic illness, treatments, or findings which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the c candidate's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
研究组 & 干预措施
Kidney transplant recipients
Experimental
This single-arm trial will administer a single dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine to kidney transplant recipients who demonstrate a persistently low (≤ 2500 u/mL) anti-spike antibody response after completion of primary series and bivalent booster of either the Moderna COVID-19 Vaccine or the Pfizer-BioNTech Vaccine, as described in their respective Food and Drug Administration (FDA) Emergency Use Authorizations (EUAs)
干预措施: Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine (Biological)
结局指标
主要结局
The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL
时间窗: At 30 days following a dose of vaccine
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
次要结局
- Composite That Includes Death, Graft Loss, Need for Dialysis, and Acute Rejection(Within 30 days following the study dose of vaccine)
- Death(Within 30 days or within 60 days of the study dose of vaccine)
- Graft Loss(Within 30 days or within 60 days of the study dose of vaccine)
- Need for Dialysis(Within 30 days or within 60 days of the study dose of vaccine)
- Acute Rejection(Within 30 days or within 60 days of the study dose of vaccine)
- Local Vaccine Reactogenicity(Collected for 7 days following the study dose of vaccine))
- Systemic Vaccine Reactogenicity(Collected for 7 days following the study dose of vaccine))
- Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases(1 year following the study dose of vaccine)
- Treated Acute Cell-mediated Allograft Rejection (Clinical or Biopsy-proven)(Within 60 days following the study dose of vaccine)
- Treated Antibody-mediated Allograft Rejection (Clinical or Biopsy-proven)(Within 60 days following the study dose of vaccine)
- Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody(Within 90 days of the vaccine and up to 12-months post vaccine)
- Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody(From study entry to 90 days post vaccine and up to 12-months post vaccine)
- Anti-RBD Antibody Concentration(At 30 days after the study dose of vaccine)
- Fold Rise (FR) in Anti-RBD Antibody Concentration(From baseline to 30 days after the study dose of vaccine)
- Monogram Pseudovirus Antibody Titers(At 14 and 30 days after the study vaccine dose)
- Median Range of Fold Rise (FR) in Monogram Pseudovirus Antibody Titers(From baseline to 14 and 30 days after the study vaccine dose)
研究者
研究点 (6)
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