A Randomized Controlled Study to Assess SARS CoV-2 Infection, Viral Shedding, and Subsequent Potential Transmission in Individuals Immunized With Moderna COVID-19 Vaccine
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,923
- Locations
- 99
- Primary Endpoint
- Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 29 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effect of Moderna COVID-19 Vaccine on Mean Peak Nasal Viral Load
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Efficacy of Moderna Vaccine Regardless of Baseline Serostatus (SARS-CoV-2 Infection by PCR)(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)
- Effect of Moderna Vaccine on Viral Load Regardless of Baseline Serostatus (Viral Load)(Measured through Month 4 study visit)
- Immunogenicity of Moderna COVID-19 Vaccine(Measured through Month 2)
- Immune Responses as Correlates of Risk of SARS-CoV-2 Acquisition, Viral Load, Secondary Infection, and COVID-19 Disease(Measured through Month 2)
- Efficacy of Moderna COVID-19 Vaccine Against Asymptomatic SARS-CoV-2 Infection(Measured through Month 4 study visit)
- Effect of Moderna COVID-19 Vaccine on Magnitude of Viral Load Over Time(Measured through Month 4 study visit)
- Efficacy of Moderna COVID-19 Vaccine Against SARS-CoV-2 Infection and COVID-19 Disease(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)
- Effect of Moderna Vaccine on Secondary Status Regardless of Baseline Serostatus (Secondary Transmission Events)(Measured through Month 4 study visit)
- Effect of Moderna COVID-19 Vaccine on Viral Load(Measured through Month 4 study visit)
- Effect of Moderna COVID-19 Vaccine on Secondary Transmission(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)