A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters

NCT ID: NCT05137236

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2023-03-23

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.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: mRNA-1283 Dose Level 1

Participants will receive single intramuscular (IM) injection of mRNA-1283 at Dose Level 1 on Day 1.

Group Type: EXPERIMENTAL

mRNA-1283

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1283 Dose Level 2

Participants will receive single IM injection of mRNA-1283 at Dose Level 2 on Day 1.

Group Type: EXPERIMENTAL

mRNA-1283

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1283 Dose Level 3

Participants will receive single IM injection of mRNA-1283 at Dose Level 3 on Day 1.

Group Type: EXPERIMENTAL

mRNA-1283

Intervention Type: BIOLOGICAL

Sterile liquid for injection

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.

Group Type: EXPERIMENTAL

mRNA-1283.211

Intervention Type: BIOLOGICAL

Sterile liquid for injection

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.

Group Type: EXPERIMENTAL

mRNA-1283.211

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1273

Participants will receive single IM injection of mRNA-1273 on Day 1.

Group Type: ACTIVE_COMPARATOR

mRNA-1273

Intervention Type: BIOLOGICAL

Sterile liquid for injection

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.

Group Type: EXPERIMENTAL

mRNA-1283.529

Intervention Type: BIOLOGICAL

Sterile liquid for injection

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.

Group Type: EXPERIMENTAL

mRNA-1283.529

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Interventions

mRNA-1283

Sterile liquid for injection

Intervention Type: BIOLOGICAL

mRNA-1283.211

Sterile liquid for injection

Intervention Type: BIOLOGICAL

mRNA-1273

Sterile liquid for injection

Intervention Type: BIOLOGICAL

mRNA-1283.529

Sterile liquid for injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

CTI Clinical Research Center

Cincinnati, Ohio, United States

Meridian Clinical Research (Cincinnati)

Cincinnati, Ohio, United States

Aventiv Research Inc

Columbus, Ohio, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

ACRC Trials

Frisco, Texas, United States

Ventavia Research Group

Houston, Texas, United States

Health Research of Hampton Roads Inc.

Newport News, Virginia, United States

Countries

United States

References

Chalkias S, Pragalos A, Akinsola A, Berman G, Ampajwala M, Meyer J, Schoch L, Zhou W, Paila YD, Deng W, Feng J, de Windt E, Edwards D, Miller J, Das R. Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine. J Infect Dis. 2025 Apr 15;231(4):e754-e763. doi: 10.1093/infdis/jiaf022.

Reference Type: DERIVED

PMID: 39792478 (View on PubMed)

Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Domain-based mRNA vaccines encoding spike protein N-terminal and receptor binding domains confer protection against SARS-CoV-2. Sci Transl Med. 2023 Sep 13;15(713):eadf4100. doi: 10.1126/scitranslmed.adf4100. Epub 2023 Sep 13.

Reference Type: DERIVED

PMID: 37703353 (View on PubMed)

Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Development of SARS-CoV-2 mRNA vaccines encoding spike N-terminal and receptor binding domains. bioRxiv [Preprint]. 2022 Oct 7:2022.10.07.511319. doi: 10.1101/2022.10.07.511319.

Reference Type: DERIVED

PMID: 36238717 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

mRNA-1283-P201

Identifier Type: -

Identifier Source: org_study_id