A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
- Conditions
- SARS-CoV-2
- Interventions
- Registration Number
- NCT05137236
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.
- Detailed Description
Part A of this study will assess whether a single dose of mRNA-1283 at three different dose levels or mRNA-1283.211 at two different dose levels will boost antibody responses to the Wuhan-Hu-1 (ancestral strain of SARS-CoV-2) virus, and to the B.1.351 variant, and potentially other SARS-CoV-2 variants, and it will also be used to select a dose for subsequent clinical evaluation. The study will include an active comparator group of participants who will receive mRNA-1273.
Participants in Part A who received the primary series of mRNA-1273 with appropriate documentation at least 6 months prior will be randomized 1:1:1:1:1:1 to receive a single boost of mRNA-1283 at one of three dose levels, a single boost of mRNA-1283.211 at one of two dose levels, or a single dose of the active comparator, mRNA-1273.
Part B of this study will assess whether a single dose of mRNA-1283.529 at two different dose levels as the second booster after a first booster of mRNA- 1273, at least 3 months prior, will boost antibody response to the ancestral strain of the SARS-CoV-2 virus, the B.1.1.529 variant, and potentially other SARS-CoV-2 variants, and inform dose selection for mRNA-1283.529 booster vaccine candidate for subsequent clinical evaluation.
Participants in Part B who received the primary series of mRNA 1273 and who received a first booster dose of mRNA-1273 at least 3 months prior will be enrolled in a 1:1 ratio to receive a single boost of mRNA 1283.529 at one of two dose levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as bilateral tubal ligation >1 year prior to screening, bilateral oophorectomy, hysterectomy, or menopause.
- Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of vaccination (Day 1), practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreed to continue adequate contraception through 3 months following the last vaccine administration, and not currently breastfeeding.
- Participant must have received their second dose of the mRNA-1273 primary series at least 6 months prior to screening and enrollment (Part A) or have received the mRNA-1273 series and an mRNA-1273 booster dose at least 3 months prior to screening and enrollment (Part B).
- Had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, defined by the US Centers for Disease Control and Prevention (CDC) as a close contact of someone who has COVID-19.
- Is acutely ill or febrile (temperature ≥38.0 degree Celsius [°C]/100.4 degree Fahrenheit [°F]) less than 72 hours prior to or at the screening visit or Day 1.
- Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
- Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Has received or plans to receive any licensed vaccine ≤28 days prior to the injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.
- Has received systemic immunoglobulins or blood products within 3 months prior to the screening visit, or plans to receive these during the study.
- Has donated ≥ 450 milliliters (mL) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study.
- Plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.
Note: Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: mRNA-1283 Dose Level 1 mRNA-1283 Participants will receive single intramuscular (IM) injection of mRNA-1283 at Dose Level 1 on Day 1. Part A: mRNA-1283 Dose Level 2 mRNA-1283 Participants will receive single IM injection of mRNA-1283 at Dose Level 2 on Day 1. Part A: mRNA-1283 Dose Level 3 mRNA-1283 Participants will receive single IM injection of mRNA-1283 at Dose Level 3 on Day 1. Part A: mRNA-1283.211 Dose Level 1 mRNA-1283.211 Participants will receive single IM injection of mRNA-1283.211 at Dose Level 1 on Day 1. Part A: mRNA-1283.211 Dose Level 2 mRNA-1283.211 Participants will receive single IM injection of mRNA-1283.211 at Dose Level 2 on Day 1. Part A: mRNA-1273 mRNA-1273 Participants will receive single IM injection of mRNA-1273 on Day 1. Part B: mRNA-1283.529 Dose Level 1 mRNA-1283.529 Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 1 on Day 1. Part B: mRNA-1283.529 Dose Level 2 mRNA-1283.529 Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 2 on Day 1.
- Primary Outcome Measures
Name Time Method Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs) Up to Day 7 An AR is any adverse event (AE) related to the IP injection. Solicited local ARs included pain at injection site, erythema (redness) at injection site, swelling (hardness) at injection site, localized axillary swelling or tenderness ipsilateral to the injection arm, and groin or underarm swelling or tenderness ipsilateral to the side of injection. Solicited systemic ARs included headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, fever, chills, irritability/crying, sleepiness, and loss of appetite. Note, not all solicited ARs were considered AEs. The Investigator determined if solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Parts A and B: Number of Participants With Unsolicited AEs Up to Day 28 An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs) Day 1 to Day 366 SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Part A: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Day 29 The GMT (50% inhibitory dose \[ID50\]) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 variant B.1.351 are reported.
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Day 29 The GMFR measures the changes in immunogenicity titers or levels within participants.
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Day 29 Seroresponse was defined as an increase of SARS-CoV-2 specific binding antibody (bAb) level or nAb titer to at least 4x lower limit of quantification (LLOQ) if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) Day 29 The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) Day 29 The GMFR measures the changes in immunogenicity titers or levels within participants.
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529) Day 29 Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
- Secondary Outcome Measures
Name Time Method Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Days 1, 29, 91, 181, and 366 The GMT (ID50) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 Variant B.1.351 are reported.
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Days 1, 29, 91, 181, and 366 The GMT of bAb against ancestral SARS-CoV-2 and against SARS-CoV-2 Variant B.1.351 are reported.
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) Days 1, 29, 91, 181, and 366 The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) Days 1, 29, 91, 181, and 366 The GMT of bAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Days 29, 91, 181, and 366 The GMFR measures the changes in immunogenicity titers or levels within participants.
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Days 29, 91, 181, and 366 The GMFR measures the changes in immunogenicity titers or levels within participants.
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) Days 29, 91, 181, and 366 The GMFR measures the changes in immunogenicity titers or levels within participants.
Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) Days 29, 91, 181, and 366 The GMFR measures the changes in immunogenicity titers or levels within participants.
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351 Days 29, 91, 181, and 366 Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529) Days 29, 91, 181, and 366 Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.
Trial Locations
- Locations (17)
MedPharmics, LLC
🇺🇸Phoenix, Arizona, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Tekton Research
🇺🇸Chamblee, Georgia, United States
MedPharmics
🇺🇸Metairie, Louisiana, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Clinical Research Institute, Inc - CRN
🇺🇸Minneapolis, Minnesota, United States
Meridian Clinical Research (Nebraska)
🇺🇸Lincoln, Nebraska, United States
MedPharmics, LLC. - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Scroll for more (7 remaining)MedPharmics, LLC🇺🇸Phoenix, Arizona, United States