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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: Placebo; Biological: mRNA-1273; Biological: mRNA-1283

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synexus Clinical Research US Phoenix Southeast, Inc.
  • California
    • San Diego, California, United States, 92108
      • Optimal Research San Diego, LLC
  • Florida
    • Melbourne, Florida, United States, 32934
      • Optimal Research Melbourne, LLC
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Optimal Research Illinois, LLC
  • Texas
    • Austin, Texas, United States, 78705
      • Optimal Research Texas, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1283 Dose Level 1; Participants will receive 2 intramuscular (IM) injections of mRNA-1283 at Dose Level 1 on Day 1 and Day 29.	Biological: mRNA-1283; Sterile liquid for injection
Experimental: mRNA-1283 Dose Level 2; Participants will receive 2 IM injections of mRNA-1283 at Dose Level 2 on Day 1 and Day 29.	Biological: mRNA-1283; Sterile liquid for injection
Experimental: mRNA-1283 Dose Level 3; Participants will receive 2 IM injections of mRNA-1283 at Dose Level 3 on Day 1 and Day 29.	Biological: mRNA-1283; Sterile liquid for injection
Experimental: mRNA-1273; Participants will receive 2 IM injections of mRNA-1273 at a pre-specified dose for this study on Day 1 and Day 29.	Biological: mRNA-1273; Sterile liquid for injection
Experimental: Placebo / mRNA-1283; Participants 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.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: mRNA-1283; Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Seroconversion measured as defined for the study.	Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394

Collaborators and Investigators

• Sponsor: ModernaTX, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; SARS-CoV-2 Vaccine; Virus Diseases; Moderna; Messenger RNA; COVID-19 Vaccine; mRNA-1273 vaccine; mRNA-1273; mRNA-1283 vaccine
• Other Study ID Numbers: mRNA-1283-P101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No