A Study of SARS CoV-2 Infection and Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine
- Conditions
- SARS-CoV-2 Infection
- Interventions
- Biological: Moderna COVID-19 Vaccine
- Registration Number
- NCT04811664
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1923
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Standard of care Moderna COVID-19 Vaccine 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. Immediate Vaccination Moderna COVID-19 Vaccine 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.
- Primary Outcome Measures
Name Time Method Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load Measured through Month 4 study visit 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.
Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Measured through Month 4 study visit 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.
Effect of Moderna COVID-19 Vaccine on Median Peak Nasal Viral Load Measured through Month 4 study visit 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.
- Secondary Outcome Measures
Name Time Method Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and Symptoms Measured through Month 4 study visit Evaluated by SARS-CoV-2 infection confirmed by PCR among participants who were SARS-CoV-2 seronegative at enrollment; reporting at least 2 of the following systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sore throat; or reporting at least one of the following signs/symptoms: cough, shortness of breath or difficulty breathing, new olfactory or taste disorder, clinical or radiographical evidence of pneumonia, thromboembolic event, myocardial infarction, myocarditis, chilblains, or multi-inflammatory syndrome
Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR) Measured through Month 4 study visit Evaluated by SARS-CoV-2 infection diagnosed by PCR
Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection Regardless of Baseline Negativity Measured through Month 4 study visit Incidence of SARS-CoV-2 infection diagnosed by study PCR among FAS-P 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.
Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load) Measured through Month 4 study visit Evaluated by peak viral load in nasal samples from diagnosed participants
Immunogenicity of Moderna COVID-19 Vaccine Measured through Month 2 Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease Measured through Month 2 Magnitude and response rate of immune responses to vaccination as measured by binding antibody and neutralization assays
Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection Measured through Month 4 study visit SARS-CoV-2 infection by PCR or periodic serology
Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time Measured through Month 4 study visit Summary measures of the viral load curve, all evaluated among participants diagnosed with SARS-CoV-2 infection who were SARS-CoV-2 seronegative at enrollment
Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease Measured through Month 4 study visit SARS-CoV-2 infection diagnosed by PCR among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
Impact of Moderna COVID-19 Vaccine on Secondary Transmission of SARS-CoV-2 Infection Measured through Month 4 study visit Evaluated by the number of secondary transmission events in close-contact cohorts from main study participants who were SARS-CoV-2 seronegative at enrollment
Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 Infection Measured through Month 4 study visit Evaluated by SARS-CoV-2 antibodies to the nucleocapsid protein post Month 1 visit among participants who were SARS-CoV-2 seronegative at enrollment
Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events) Measured through Month 4 study visit Evaluated by number of secondary transmission events in close-contact cohorts
Effect of Moderna COVID-19 Vaccine on Viral Load Measured through Month 4 study visit Measure of peak viral load among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
Effect of Moderna COVID-19 Vaccine on Secondary Transmission Measured through Month 4 study visit Measure of secondary transmission events among participants who were SARS-CoV-2 seronegative at enrollment and who received all planned immunizations at designated immunization visits
Trial Locations
- Locations (51)
Charles Drew University
🇺🇸Los Angeles, California, United States
The Hope Clinic of the Emory Vaccine Center CRS
🇺🇸Decatur, Georgia, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
Fenway Health (FH) CRS
🇺🇸Boston, Massachusetts, United States
Centex Studies, Inc. - Westfield
🇺🇸Houston, Texas, United States
Centex Studies, Inc. - Houston
🇺🇸Houston, Texas, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Univ, of Kansas School of Medicine CRS
🇺🇸Wichita, Kansas, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Alabama CRS
🇺🇸Birmingham, Alabama, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Vanderbilt Vaccine CRS
🇺🇸Nashville, Tennessee, United States
Headlands Research Scottsdale
🇺🇸Scottsdale, Arizona, United States
AMR Phoenix
🇺🇸Tempe, Arizona, United States
University of Colorado- Boulder
🇺🇸Boulder, Colorado, United States
JEM Headlands LLC
🇺🇸Atlantis, Florida, United States
UF CARES
🇺🇸Jacksonville, Florida, United States
Morehouse University
🇺🇸Atlanta, Georgia, United States
Headlands Research Sarasota
🇺🇸Sarasota, Florida, United States
Champaign-Urbana Public Health District
🇺🇸Champaign, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Rush University CRS
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Bloomington, Indiana, United States
Centex Studies, Inc. - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
University of Maryland College Park
🇺🇸College Park, Maryland, United States
Wayne State - Harper Hospital
🇺🇸Detroit, Michigan, United States
AMR Las Vegas
🇺🇸Las Vegas, Nevada, United States
Columbia - Missouri VTEU
🇺🇸Columbia, Missouri, United States
Washington University Therapeutics CRS
🇺🇸Saint Louis, Missouri, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
NYU Long Island Vaccine Center
🇺🇸Mineola, New York, United States
Bronx Prevention Research Center CRS
🇺🇸Bronx, 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
The Miriam Hopsital CRS
🇺🇸Providence, Rhode Island, United States
Texas Tech
🇺🇸Amarillo, Texas, United States
Texas A&M University
🇺🇸College Station, Texas, United States
Centex Studies, Inc. - Brownsville
🇺🇸Brownsville, Texas, United States
Texas A&M - Kingsville
🇺🇸Kingsville, Texas, United States
Orlando Immunology Center CRS
🇺🇸Orlando, Florida, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
UC Davis
🇺🇸Sacramento, California, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Clemson University
🇺🇸Clemson, South Carolina, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States