A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine

NCT ID: NCT04811664

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1923 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-24
• Study Completion Date: 2021-12-30

Brief Summary

The purpose of this study is to assess SARS CoV-2 infection, viral shedding, and subsequent potential transmission in individuals immunized with the Moderna COVID-19 vaccine.

Detailed Description

This study will evaluate the efficacy of the Moderna COVID-19 vaccine against SARS-CoV-2 infection, as well as its effect on peak nasal viral load as a measure of infection and a proxy of infectiousness, in adults aged 18-29.

In the Main study, up to 12,000 participants will be randomized 1:1 to Immediate Vaccination Group 1 (at Months 0 and 1) or Standard of Care Group 2, with vaccination given at Months 4 and 5 if not received off-study previously. Up to an additional 6,000 participants will be enrolled into the Vaccine Declined Group 3 and will also be offered vaccine at Months 4 and 5.

Additional study visits for Group 1 will occur at Months 2 and 4; for Groups 2 and 3, at Months 0 and 2. Study visits may include medical history, vaccine injections, blood collection, nasal swab, SARS-CoV-2 screening, COVID-19 symptom check, and questionnaires.

In addition to the main study participants, the study will also evaluate infectiousness following close contacts with main study participants. Study procedures for close contacts include questionnaires and blood samples; for those who become SARS-CoV-2 infected, study procedures will also include nasal swabs.

Conditions

SARS-CoV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Immediate Vaccination

Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 1 and Day 29.

Group Type: EXPERIMENTAL

Moderna COVID-19 Vaccine

Intervention Type: BIOLOGICAL

A lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available). It is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.

Standard of care

Participants will receive Moderna COVID-19 Vaccine in 100 mcg dose given as 0.5 ml Intramuscular into the deltoid muscle on Day 113 and Day 141.

Group Type: EXPERIMENTAL

Moderna COVID-19 Vaccine

Intervention Type: BIOLOGICAL

A lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available). It is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.

Vaccine Declined

Participants who prefer not to be vaccinated, If requested, participant will be offered vaccine if they have not received vaccine outside of the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Moderna COVID-19 Vaccine

A lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available). It is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.

Intervention Type: BIOLOGICAL

Other Intervention Names

mRNA-1273

Eligibility Criteria

Inclusion Criteria

• Age of 18 through 29 years.
• Ability and willingness to provide informed consent.
• Prefers not to receive COVID-19 vaccine.
• Willingness to be followed for the planned duration of the study.
• Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire with demonstration of understanding of all questionnaire items answered incorrectly.
• Access to device and internet for completion of study procedures.

• Age of 18 years or older, at the time of signing the informed consent.
• Willing and able to provide informed consent.
• Expected to be in frequent close physical proximity with Main Cohort participant during the study.
• Willing to share results of SARS-CoV-2 testing.
• Access to device and internet for completion of study procedures

• Age of 18 years or older, at the time of signing the informed consent.
• Willing and able to provide informed consent.
• Access to device and internet for completion of study procedures.
• Willing to share results of SARS-CoV-2 testing.
• Had close contact with Main Cohort participant with known PCR-confirmed SARS-CoV-2 infection (eg, index case). Close contacts will have had exposure to the index participant, generally within 72 hours of an index diagnosis, and may include individuals that meet any of the following guidelines:

Prolonged close physical proximity with Main Cohort participant within a residence/vehicle/enclosed space without maintaining social distance,

Medical staff, first responders, or other care persons who cared for the index case without appropriate personal protective equipment.

Further information on the definition of close contact can be found in the CoVPN 3006 Study Specific Procedures (SSP).

Exclusion Criteria

• Prior administration of a coronavirus (SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19 (participation in studies of other investigational research agents allowed).
• Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, or a volunteer's ability to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn Stephenson

Role: STUDY_CHAIR

Harvard University School of Medicine

Audrey Pettifor

Role: STUDY_CHAIR

Gillings School of Global Public Health, University of North Carolina

Jasmine Marcelin

Role: STUDY_CHAIR

University of Nebraska

Locations

Alabama CRS

Birmingham, Alabama, United States

Headlands Research Scottsdale

Scottsdale, Arizona, United States

AMR Phoenix

Tempe, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Charles Drew University

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

University of California, San Diego

San Diego, California, United States

University of Colorado- Boulder

Boulder, Colorado, United States

JEM Headlands LLC

Atlantis, Florida, United States

University of Florida

Gainesville, Florida, United States

UF CARES

Jacksonville, Florida, United States

Orlando Immunology Center CRS

Orlando, Florida, United States

Headlands Research Sarasota

Sarasota, Florida, United States

University of South Florida

Tampa, Florida, United States

Morehouse University

Atlanta, Georgia, United States

The Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia, United States

Champaign-Urbana Public Health District

Champaign, Illinois, United States

Rush University CRS

Chicago, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Indiana University

Bloomington, Indiana, United States

Univ, of Kansas School of Medicine CRS

Wichita, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Centex Studies, Inc. - Lake Charles

Lake Charles, Louisiana, United States

University of Maryland College Park

College Park, Maryland, United States

Fenway Health (FH) CRS

Boston, Massachusetts, United States

Wayne State - Harper Hospital

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Columbia - Missouri VTEU

Columbia, Missouri, United States

Washington University Therapeutics CRS

St Louis, Missouri, United States

University of Nebraska

Omaha, Nebraska, United States

AMR Las Vegas

Las Vegas, Nevada, United States

University of New Mexico

Albuquerque, New Mexico, United States

NYU Long Island Vaccine Center

Mineola, New York, United States

NYU Bellevue Vaccine Center

New York, New York, United States

Harlem Prevention Center CRS

New York, New York, United States

New York Blood Center CRS

New York, New York, United States

Stony Brook University

Stony Brook, New York, United States

Bronx Prevention Research Center CRS

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

The Miriam Hopsital CRS

Providence, Rhode Island, United States

Clemson University

Clemson, South Carolina, United States

Vanderbilt Vaccine CRS

Nashville, Tennessee, United States

Texas Tech

Amarillo, Texas, United States

Centex Studies, Inc. - Brownsville

Brownsville, Texas, United States

Texas A&M University

College Station, Texas, United States

Centex Studies, Inc. - Houston

Houston, Texas, United States

Centex Studies, Inc. - Westfield

Houston, Texas, United States

Texas A&M - Kingsville

Kingsville, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

Vielot NA, Kelly NK, Ludema C, Rosenberg M, Brown ER, Janes HE, Kublin JG, Stephenson KE, Marcelin JR, Pettifor A. Patterns and predictors of COVID-19 vaccination among young adults at 44 US sites: Secondary analysis of a randomized, controlled, open-label trial, March - December 2021. Vaccine. 2024 Oct 3;42(23):126237. doi: 10.1016/j.vaccine.2024.126237. Epub 2024 Aug 24.

Reference Type: DERIVED

PMID: 39182315 (View on PubMed)

Stephenson KE, Marcelin JR, Pettifor AE, Janes H, Brown E, Neradilek M, Yen C, Andriesen J, Grunenberg N, Espy N, Trahey M, Fischer RSB, DeSouza CA, Shisler JL, Connick E, Houpt ER, Chu HY, McCulloh RJ, Becker-Dreps S, Vielot NA, Kalbaugh CA, Cherabuddi K, Krueger KM, Rosenberg M, Greenberg RN, Joaquin A, Immergluck LC, Corey L, Kublin JG. Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021. Open Forum Infect Dis. 2023 Nov 2;10(11):ofad511. doi: 10.1093/ofid/ofad511. eCollection 2023 Nov.

Reference Type: DERIVED

PMID: 38023544 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CoVPN 3006

Identifier Type: -

Identifier Source: org_study_id