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

NCT04811664 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CoVPN 3006
• Study Type: interventional
• Target: 1,923
• Locations: 1 country
• Sites: 51

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.

Conditions

SARS-CoV-2 Infection

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection

  Incidence of SARS-CoV-2 infection diagnosed by study PCR among baseline negative participants, with exposure starting from first study PCR and censored at last PCR/outside vaccination and exposure period for the Immediate arm additionally limited to period after the second vaccine dose (period unrestricted for Standard of Care and Vaccine Declined arms: by definition corresponds to unvaccinated exposure). Exact confidence interval.

  Measured through Month 4 study visit

• Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load

  As a measure of infection and a proxy of infectiousness, mean observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.

  Measured through Month 4 study visit

• Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load

  As a measure of infection and a proxy of infectiousness, median observed peak viral load (minimum cycle threshold) in nasal samples from FAS-P participants diagnosed with SARS-CoV-2 infection, stratified by lab and target (nucleocapsid gene N1 or N2). Nasal swabs were to be collected daily, and viral load was measured on available specimens taken between the first and last days of PCR-confirmed SARS-CoV-2 infection. Due to early termination, the study was underpowered to look at the vaccine effect on viral load and limited descriptive analysis was performed. The number participants analyzed per row is less than the overall number analyzed as participants were only analyzed by one of the two labs and in few cases the N2 target values could not be measured.

  Measured through Month 4 study visit

Secondary Outcomes (15)

• Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms

  Measured through Month 4 study visit

• Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity

  Measured through Month 4 study visit

• Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection

  Measured through Month 4 study visit

• Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection

  Measured through Month 4 study visit

• Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms

  Measured through Month 4 study visit

Study Arms (3)

Immediate Vaccination

EXPERIMENTAL

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.

Biological: Moderna COVID-19 Vaccine

Standard of care

EXPERIMENTAL

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.

Biological: Moderna COVID-19 Vaccine

Vaccine Declined

NO INTERVENTION

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

Interventions

Moderna COVID-19 Vaccine 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.

Also known as: mRNA-1273

Immediate Vaccination; Standard of care

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (51)

Alabama CRS

Birmingham, Alabama, 35222, United States

Location

Headlands Research Scottsdale

Scottsdale, Arizona, 85260, United States

Location

AMR Phoenix

Tempe, Arizona, 85281, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Charles Drew University

Los Angeles, California, 90059, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

University of Colorado- Boulder

Boulder, Colorado, 80301, United States

Location

JEM Headlands LLC

Atlantis, Florida, 33462, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

UF CARES

Jacksonville, Florida, 32209, United States

Location

Orlando Immunology Center CRS

Orlando, Florida, 32803, United States

Location

Headlands Research Sarasota

Sarasota, Florida, 34243, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Morehouse University

Atlanta, Georgia, 30310, United States

Location

The Hope Clinic of the Emory Vaccine Center CRS

Decatur, Georgia, 30030, United States

Location

Champaign-Urbana Public Health District

Champaign, Illinois, 61820, United States

Location

Rush University CRS

Chicago, Illinois, 60612, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Indiana University

Bloomington, Indiana, 47405-7000, United States

Location

Univ, of Kansas School of Medicine CRS

Wichita, Kansas, 67214, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Centex Studies, Inc. - Lake Charles

Lake Charles, Louisiana, 70601, United States

Location

University of Maryland College Park

College Park, Maryland, 20742-2611, United States

Location

Fenway Health (FH) CRS

Boston, Massachusetts, 02215-4302, United States

Location

Wayne State - Harper Hospital

Detroit, Michigan, 48201, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Columbia - Missouri VTEU

Columbia, Missouri, 65201, United States

Location

Washington University Therapeutics CRS

St Louis, Missouri, 63110, United States

Location

University of Nebraska

Omaha, Nebraska, 68105, United States

Location

AMR Las Vegas

Las Vegas, Nevada, 89119, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

NYU Long Island Vaccine Center

Mineola, New York, 11501, United States

Location

NYU Bellevue Vaccine Center

New York, New York, 10016, United States

Location

Harlem Prevention Center CRS

New York, New York, 10027, United States

Location

New York Blood Center CRS

New York, New York, 10065, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Bronx Prevention Research Center CRS

The Bronx, New York, 10451, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

The Miriam Hopsital CRS

Providence, Rhode Island, 02904, United States

Location

Clemson University

Clemson, South Carolina, 29634, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

Texas Tech

Amarillo, Texas, 79106, United States

Location

Centex Studies, Inc. - Brownsville

Brownsville, Texas, 78526, United States

Location

Texas A&M University

College Station, Texas, 77843, United States

Location

Centex Studies, Inc. - Houston

Houston, Texas, 77058, United States

Location

Centex Studies, Inc. - Westfield

Houston, Texas, 77090, United States

Location

Texas A&M - Kingsville

Kingsville, Texas, 77843, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (2)

• 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.

  PMID: 39182315 DERIVED

• 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.

  PMID: 38023544 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
• Organization: Fred Hutchinson Cancer Center

hvtn.covpn.sdmc@hvtn.org

206-667-5812

Study Officials

• Kathryn Stephenson

  Harvard University School of Medicine

  STUDY CHAIR

• Audrey Pettifor

  Gillings School of Global Public Health, University of North Carolina

  STUDY CHAIR

• Jasmine Marcelin

  University of Nebraska

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: March 24, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 2, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Locations

US (51)