- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05137236
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters
A Phase 2A, Randomized, Stratified, Observer-Blind Study to Evaluate the Immunogenicity and Safety of mRNA-1283 Vaccine Boosters for SARS-CoV-2
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85015-1105
- MedPharmics, LLC
-
-
Florida
-
Hollywood, Florida, United States, 33024-2709
- Research Centers of America
-
Sunrise, Florida, United States, 33351-7311
- Precision Clinical Research
-
-
Georgia
-
Chamblee, Georgia, United States, 30341
- Tekton Research
-
-
Louisiana
-
Metairie, Louisiana, United States, 70006
- MedPharmics
-
-
Massachusetts
-
Worcester, Massachusetts, United States, 01655-0002
- UMass Memorial Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55402-2700
- Clinical Research Institute, Inc - CRN
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68510
- Meridian Clinical Research (Nebraska)
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102-3876
- MedPharmics, LLC. - Albuquerque
-
-
New York
-
Rochester, New York, United States, 14609
- Rochester Clinical Research, Inc.
-
-
Ohio
-
Cincinnati, Ohio, United States, 45212
- CTI Clinical Research Center
-
Cincinnati, Ohio, United States, 45246-2316
- Meridian Clinical Research (Cincinnati)
-
Columbus, Ohio, United States, 43213-6517
- Aventiv Research Inc
-
-
South Carolina
-
North Charleston, South Carolina, United States, 29405-4986
- Coastal Carolina Research Center
-
-
Texas
-
Frisco, Texas, United States, 75033-4135
- ACRC Trials
-
Houston, Texas, United States, 77008
- Ventavia Research Group
-
-
Virginia
-
Newport News, Virginia, United States, 23606-4537
- Health Research of Hampton Roads Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A: mRNA-1283 Dose Level 1
Participants will receive single intramuscular (IM) injection of mRNA-1283 at Dose Level 1 on Day 1.
|
Sterile liquid for injection
|
Experimental: Part A: mRNA-1283 Dose Level 2
Participants will receive single IM injection of mRNA-1283 at Dose Level 2 on Day 1.
|
Sterile liquid for injection
|
Experimental: Part A: mRNA-1283 Dose Level 3
Participants will receive single IM injection of mRNA-1283 at Dose Level 3 on Day 1.
|
Sterile liquid for injection
|
Experimental: Part A: mRNA-1283.211 Dose Level 1
Participants will receive single IM injection of mRNA-1283.211
at Dose Level 1 on Day 1.
|
Sterile liquid for injection
|
Experimental: Part A: mRNA-1283.211 Dose Level 2
Participants will receive single IM injection of mRNA-1283.211
at Dose Level 2 on Day 1.
|
Sterile liquid for injection
|
Active Comparator: Part A: mRNA-1273
Participants will receive single IM injection of mRNA-1273 on Day 1.
|
Sterile liquid for injection
|
Experimental: Part B: mRNA-1283.529 Dose Level 1
Participants will receive single IM injection of mRNA-1283.529
as a second booster at Dose Level 1 on Day 1.
|
Sterile liquid for injection
|
Experimental: Part B: mRNA-1283.529 Dose Level 2
Participants will receive single IM injection of mRNA-1283.529
as a second booster at Dose Level 2 on Day 1.
|
Sterile liquid for injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parts A and B: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame: Up to Day 7 (7-day follow-up after vaccination)
|
Up to Day 7 (7-day follow-up after vaccination)
|
Parts A and B: Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 28 (28-day follow-up after vaccination)
|
Up to Day 28 (28-day follow-up after vaccination)
|
Parts A and B: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs)
Time Frame: Day 1 to end of study (EOS) (Day 366)
|
Day 1 to end of study (EOS) (Day 366)
|
Part A: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
Time Frame: Day 29
|
Day 29
|
Part A: GMT of SARS-CoV-2 Specific Binding Antibody (bAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
Time Frame: Day 29
|
Day 29
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29
Time Frame: Day 29
|
Day 29
|
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29
Time Frame: Day 29
|
Day 29
|
Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
Time Frame: Day 29
|
Day 29
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
Time Frame: Day 29
|
Day 29
|
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29
Time Frame: Day 29
|
Day 29
|
Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29
Time Frame: Day 29
|
Day 29
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Day 29
Time Frame: Day 29
|
Day 29
|
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Day 29
Time Frame: Day 29
|
Day 29
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part A: GMFR of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part B: GMFR of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variants, Including B.1.351 at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529) at Days 1, 15, 29, 181, and 366
Time Frame: Days 1, 15, 29, 90, 181, and 366
|
Days 1, 15, 29, 90, 181, and 366
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- mRNA-1283-P201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on SARS-CoV-2
-
Argorna Pharmaceuticals Co., LTDCompleted
-
Argorna Pharmaceuticals Co., LTDCompleted
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Active, not recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Active, not recruiting
-
Arcturus Therapeutics, Inc.Terminated
-
University Hospital Inselspital, BerneUniversity of Bern; Lucerne University of Applied Sciences and ArtsCompleted
-
Centre Hospitalier Universitaire DijonUnknown
-
AIM Vaccine Co., Ltd.Zhejiang Provincial Center for Disease Control and PreventionNot yet recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Not yet recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical CollegeActive, not recruiting
Clinical Trials on mRNA-1273
-
ModernaTX, Inc.Completed
-
National Institute of Allergy and Infectious Diseases...ModernaTX, Inc.CompletedCOVID-19 | COVID-19 ImmunisationUnited States
-
ModernaTX, Inc.CompletedInfluenza | SARS-CoV-2United States
-
ModernaTX, Inc.Completed
-
ModernaTX, Inc.Completed
-
ModernaTX, Inc.Active, not recruitingCytomegalovirus | SARS-CoV-2 | Seasonal Influenza | Respiratory Syncytial VirusUnited States
-
ModernaTX, Inc.Biomedical Advanced Research and Development AuthorityCompleted
-
ModernaTX, Inc.Recruiting
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceNot yet recruiting