Planned COVID-19 vaccine trials require screening, enrolling, and following over 150,000 volunteer study participants over 24 months. The trial participants will be selected based on their risk of COVID-19 infection, with trial participants coming from settings with high rates of community transmission, groups with higher risk of progression to symptomatic disease, or both. Study staff working on COVID-19 vaccine trials will need to interact with trial participants during regular visits as well as conducting in-person assessments of all vaccine trial participants with symptoms that could be due to COVID-19 disease. This will result in close contact between study staff and high-risk participants or infected participants. As a result, study staff need to access a regular supply of personal protective equipment (PPE), including surgical masks, face shields or goggles, gowns, and disposable gloves, as well as the ability to sanitize hands frequently. This combination of PPE will be used during all risky interactions with study participants, such as during nasal swab collection and during evaluation of participants for possible study endpoints, including symptomatic COVID-19 disease. In addition, all staff will need to wear surgical face masks during and throughout their normal workday in the health care setting or on site for mobile study satellite sites. Without appropriate PPE, health care workers are vulnerable to infection with COVID-19, as well as passively transmitting to persons with whom they are in close physical contact. Access to adequate PPE is a critical component of the safe and effective conduct of COVID-19 vaccine trials, and will enable accurate determination of the study endpoints, especially symptomatic COVID- 19 disease.
COVID-19 vaccine trials will entail surveillance, testing and monitoring of an estimated 30,000 trial volunteers in each of 4-6 planned vaccine trials to enroll in the next 12 months. Vaccine trial staff will be in close contact with community volunteers selected for risk of COVID-19 acquisition or higher risk of progression to severe disease. To safely conduct this trial, study staff will need access to personal protective equipment (PPE) as they interact with study participants, especially as they evaluate participants for the primary endpoint of COVID-19 disease.
