St. Jude Tracking of Viral and Host Factors Associated With COVID-19

Naive individuals will contribute a baseline blood sample at enrollment. Subsequent routine blood draws will occur to determine the proportion of participants who have asymptomatically seroconverted; the timing of these blood draws and proportion of participants required will be determined by the rate of documented SARS-CoV-2 infection in the cohort according to an adaptive study design. Participants will be tracked for SARS-CoV-2 specific antibodies and CD4, and CD8 T cell responses throughout the period and especially during the early stages after clearance of infection and subsequently to determine the quality and duration of memory responses.

In addition to blood samples, participants will intermittently provide nasal swabs for detection of SARS-CoV-2; this will occur either through a comprehensive proactive employee screening program, or specifically for the purposes of the research study if participants are required to attend campus but are not currently eligible for employee screening. These will determine duration and characteristics of viral shedding and identify reinfection. Seroprevalence estimates and asymptomatic conversion will also be determined.

Individuals with a diagnosis of COVID-19 infection will have two additional blood draws in the acute and convalescent phase to identify acute and late immune responses. These responses will be compared to the essential baseline sample data to characterize the generation of de novo and cross-reactive recall responses.

For those participants receiving vaccination, blood draws will be taken after COVID vaccine (3-8 weeks after completion of 1 or 2 dose course) and at completion of study.

At enrollment, subjects will complete a baseline online personal health and demographic questionnaire, and then monthly brief online health update questionnaires. Throughout the study period, subjects will complete a brief online symptom survey every 2 weeks.

Participants in the original SJTRC study will be asked to reconsent to complete a one-time questionnaire regarding their COVID-19 experience specifically during the time since they went off study. Once this questionnaire is complete, they will be taken off study and receive no further questionnaires related to the original study.

A subset of participants will be invited to re-enroll in a long-term follow-up phase to evaluate long-term immunity and protection against COVID-19 following infection and vaccination. Participants will provide blood samples every 6 months. They will also be invited to provide additional acute and convalescent samples (blood and saliva), if diagnosed with acute COVID-19 during this period. Participants will continue to complete regular questionnaires, but the frequency will decrease to 6 monthly (health questionnaires) and as needed (COVID-19 diagnosis or vaccination).

Inclusion criteria

• Adult St. Jude employees (Age ≥ 18 years of age) who are presumed to be SARS- CoV-2 naive, or have a recent diagnosis of COVID-19, and volunteer to participate.
• Willing to undergo blood draws on up to 5 occasions during the study.
• Receiving approximately twice-weekly SARS-CoV-2 screening by Occupational Health, or willing to provide up to twice weekly nasal self-swabs if attending campus.
• Have access to a personal smartphone that is able to receive and respond to text messages for data collection.
• Has ready access to the internet to log personal study information into the REDCap database.
• Self-identified as able to speak and read English well enough to understand the consent process and survey forms, and to report symptoms.

Inclusion criteria

for LTFU arm:

• Adult St. Jude employees (age ≥ 18 years of age) who participated in the original SJTRC study.
• Willing to undergo blood draws on up to five occasions during the LTFU arm. Willing to provide saliva samples at acute and convalescent episodes.
• Have access to a personal smartphone that is able to receive and respond to text messages for data collection.
• Have ready access to the internet to log personal study information into the REDCap database.
• Self-identified as able to speak and read English well enough to understand the consent process and questionnaires, and to report symptoms.

Exclusion criteria

• Employees who are first-degree relatives of, or directly or indirectly report up to, the PI or any of the clinical study investigators who will have access to participant identities.
• Employees who cannot complete the informed consent process.

Exclusion criteria

for LTFU arm:

• Employees who did not participate in the original SJTRC study.
• Employees who cannot complete the informed consent process.