The proposed project is a randomized controlled open-label multicenter study to assess SARS-CoV-2 infection, viral shedding, and subsequent potential transmission in university students immunized with Moderna COVID-19 vaccine. Ongoing phase 3 COVID-19 vaccination studies are designed to evaluated vaccine efficacy against symptomatic disease. Further research is needed to estimate all infections, including asymptomatic infection, and vaccine effects on infectiousness as measured by viral shedding and onward transmission of infection. University students were selected for this study as young adults are particularly at risk for acquiring and transmitting SARS-CoV-2 and many universities have implemented intensive testing for SARS-CoV-2 among their students. This will allow for infections to be identified among participants in real time. The primary objectives are to evaluate efficacy of Moderna COVID-19 vaccine against SARS-CoV-2 infection and the effect on peak nasal viral load as a measure of infection and a proxy of infectiousness. Study wide, approximately 12,000 healthy university student volunteers aged 18 through 26 years old will be randomized to immediate vaccination or delayed vaccination. Participants will be monitored for approximately 5 months. At Northwestern, we will aim to enroll between 500 and 1000 participants. Up to 24,000 volunteers subject to university SARS-CoV-2 testing who are in frequent close physical proximity with main study participants will be recruited to participate in a prospective close contact cohort. And approximately 3 contacts per incident case will be recruited as part of a case-ascertained closed contact cohort. Participants will be required to record symptoms daily in an electronic diary and perform daily nasal swabs in addition to twice weekly testing for SARS-CoV-2 through Northwestern University.
|Effective start/end date||2/1/21 → 11/30/21|
- Fred Hutchinson Cancer Research Center (0001060752 // 3UM1AI068614-14S1)
- National Institute of Allergy and Infectious Diseases (0001060752 // 3UM1AI068614-14S1)
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