Clinical Trial 21355

Study Title

Prospective Cohort Study Of The Immune Response To Severe Acute Respiratory Coronavirus 2 (SARS-Cov2) In Oncology Workers: Protect Covid-19 Study

Summary

Objective

The main long-term goal of this proposal is to assess measures of immune activation after vaccination for SARS-CoV2 among oncology workers. Note: The study population includes oncology workers from any health care institution in the state of Florida who is willing to come to Moffitt Cancer for study participation. 2.1 PRIMARY OBJECTIVE AND ENDPOINT To assess measures of immune activation against SARS-CoV2 (longitudinally) in the study population which consists of vaccinated oncology workers. Note: Longitudinal assessments of serum IgG titers and CD4+ (ELISPOT) immune response against SARS-CoV2 spike protein. Note: Vaccinations will be conducted as part of standard of care and NOT as part of the study. There are no interventions planned for this observational cohort study. 2.2 SECONDARY OBJECTIVES 1. To compare longitudinal measures of immune activation (i.e., serum IgG titers and CD4+[ELISPOT]) at baseline, 12 months, and 24 months. 2. To assess the absolute risk of Covid-19 infection among participants treated with SARSCoV2 during study period. Note: Confirmed Covid-19 is defined according to the Food and Drug Administration (FDA) criteria as the presence of at least one of the following symptoms: fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea, or vomiting, combined with a respiratory specimen obtained during the symptomatic period or within 4 days before or after it that was positive for SARS-CoV-2 by nucleic acid amplification based testing. 3. To assess correlations between measures of immune activation against SARS-CoV2 and participant-associated characteristics (e.g., age, comorbidities, previous diagnosis of covid-19 infection).