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

Phase 3
Completed
Conditions
SARS-CoV-2 Infection
Registration Number
NCT04811664
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral LoadMeasured 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 InfectionMeasured 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 LoadMeasured 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
NameTimeMethod
Efficacy of Moderna COVID-19 Vaccine to Prevent Serologically Confirmed SARS-CoV-2 InfectionMeasured 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

Efficacy of Moderna COVID-19 Vaccine Against COVID-19 Disease Confirmed by PCR Test and SymptomsMeasured 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 NegativityMeasured 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 VaccineMeasured 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 DiseaseMeasured 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 InfectionMeasured 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 TimeMeasured 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 DiseaseMeasured 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 InfectionMeasured 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

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 LoadMeasured 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 TransmissionMeasured 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)

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

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Alabama CRS
🇺🇸Birmingham, Alabama, United States
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