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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04813796
Recruitment Status : Active, not recruiting
First Posted : March 24, 2021
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: mRNA-1283 Biological: mRNA-1273 Biological: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants who are offered an opportunity to receive an additional injection of mRNA-1273, will participate in an open-label part of the study.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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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: mRNA-1283
Sterile liquid for injection

Biological: Placebo
0.9% sodium chloride (normal saline) injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after second dose) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after second dose) ]
  3. Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]

Secondary Outcome Measures :
  1. Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 ]
  2. GM of SARS-CoV-2-Specific Binding Antibody (bAb) [ Time Frame: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 ]
  3. Seroconversion as Measured by an Increase of SARS-CoV-2-Specific nAb Titer or bAb Titer [ Time Frame: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394 ]
    Seroconversion measured as defined for the study.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813796


Locations
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United States, Arizona
Synexus Clinical Research US Phoenix Southeast, Inc.
Chandler, Arizona, United States, 85224
United States, California
Optimal Research San Diego, LLC
San Diego, California, United States, 92108
United States, Florida
Optimal Research Melbourne, LLC
Melbourne, Florida, United States, 32934
United States, Illinois
Optimal Research Illinois, LLC
Peoria, Illinois, United States, 61614
United States, Texas
Optimal Research Texas, LLC
Austin, Texas, United States, 78705
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04813796    
Other Study ID Numbers: mRNA-1283-P101
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1283 vaccine
mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
 Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna