A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19
A Phase 1, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18-55 Years
1 other identifier
interventional
104
1 country
5
Brief Summary
The primary goal for this study is to evaluate the safety and reactogenicity of 3 dose levels of mRNA-1283 and 1 dose level of mRNA-1273 vaccine given to healthy adults in 2 doses, 28 days apart, and 1 dose level of mRNA-1283 administered as a single dose to healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2021
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2021
CompletedFirst Submitted
Initial submission to the registry
March 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2023
CompletedAugust 1, 2023
July 1, 2023
2.4 years
March 22, 2021
July 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Up to Day 36 (7 days after second dose)
Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 57 (28 days after second dose)
Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Up to Day 394 (1 year after second dose)
Secondary Outcomes (3)
Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
GM of SARS-CoV-2-Specific Binding Antibody (bAb)
Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
Seroconversion as Measured by an Increase of SARS-CoV-2-Specific nAb Titer or bAb Titer
Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
Study Arms (5)
mRNA-1283 Dose Level 1
EXPERIMENTALParticipants will receive 2 intramuscular (IM) injections of mRNA-1283 at Dose Level 1 on Day 1 and Day 29.
mRNA-1283 Dose Level 2
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1283 at Dose Level 2 on Day 1 and Day 29.
mRNA-1283 Dose Level 3
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1283 at Dose Level 3 on Day 1 and Day 29.
mRNA-1273
EXPERIMENTALParticipants will receive 2 IM injections of mRNA-1273 at a pre-specified dose for this study on Day 1 and Day 29.
Placebo / mRNA-1283
EXPERIMENTALParticipants will receive 1 IM injection of study drug-matching placebo on Day 1 and 1 IM injection of mRNA-1283 at a pre-specified dose on Day 29. Participants may be offered an opportunity to receive an additional injection of mRNA-1273 at the pre-specified dose on Open-Label Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Understands and agrees to comply with the study procedures and provides written informed consent.
- According to the assessment of the investigator, is in good general health and can comply with study procedures.
- Body mass index (BMI) of 18 kilograms/square meter (kg/m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit (Day 0).
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding.
You may not qualify if:
- Known history of SARS-CoV-2 infection or known exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 30 days.
- Positive serology results for SARS-CoV-2 at the Screening Visit. A negative serological test for SARS-CoV-2, performed on a blood sample obtained at the Screening Visit, is required before a participant can be dosed.
- Travel outside of the United States in the 28 days prior to the Screening Visit (Day 0).
- Prior administration of an investigational, authorized, or licensed CoV (for example, SARS-CoV-2, SARS-CoV, or Middle East Respiratory Syndrome \[MERS\]-CoV) vaccine, based on medical history interview.
- Current treatment with investigational agents for prophylaxis against COVID-19.
- Recent (within the last 12 months) use of a dermal filler.
- 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 first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before the first study injection or more than 14 days after the second study injection.
- Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study.
- Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine vapors).
- History of chronic smoking (1 cigarette a day) within 1 year of the Screening Visit.
- Resides in a nursing home.
- 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.
- Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (5)
Synexus Clinical Research US Phoenix Southeast, Inc.
Chandler, Arizona, 85224, United States
Optimal Research San Diego, LLC
San Diego, California, 92108, United States
Optimal Research Melbourne, LLC
Melbourne, Florida, 32934, United States
Optimal Research Illinois, LLC
Peoria, Illinois, 61614, United States
Optimal Research Texas, LLC
Austin, Texas, 78705, United States
Related Publications (1)
Yassini P, Hutchens M, Paila YD, Schoch L, Aunins A, Siangphoe U, Paris R. Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. Hum Vaccin Immunother. 2023 Dec 31;19(1):2190690. doi: 10.1080/21645515.2023.2190690. Epub 2023 Apr 19.
PMID: 37074202DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants who are offered an opportunity to receive an additional injection of mRNA-1273, will participate in an open-label part of the study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2021
First Posted
March 24, 2021
Study Start
March 11, 2021
Primary Completion
July 25, 2023
Study Completion
July 25, 2023
Last Updated
August 1, 2023
Record last verified: 2023-07