A Study of SARS CoV-2 Infection and Potential Transmission in University Students Immunized With Moderna COVID-19 Vaccine
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- SARS CoV-2 Infection
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 26 years
- Gender
- Both males and females
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 university students aged 18-26. Participants will be randomly assigned to 1 of 2 groups. Part...
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 university students aged 18-26. Participants will be randomly assigned to 1 of 2 groups. Participants in Group 1 will receive the Moderna COVID-19 vaccine by injection at Months 0 and 1; participants in Group 2 will receive the Moderna COVID-19 vaccine by injection at Months 4 and 5. Additional study visits for Group 1 will occur at Months 2 and 4; for Group 2, 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.
Tracking Information
- NCT #
- NCT04811664
- Collaborators
- Not Provided
- Investigators
- Study Chair: 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
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