This study examines the immune response in patients with cancer to the novel RNA-based COVID-19 vaccination. Collecting and analyzing blood samples and nasal swabs in the laboratory from cancer patients receiving the COVID vaccination, may help doctors learn more about the safety and effectiveness of the COVID-19 vaccine and their bodies’ immune response to the COVID-19 vaccination.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04784689.
PRIMARY OBJECTIVE:
I. To determine the antibody response level in patients with cancer to the coronavirus 2019 (COVID-19) vaccination.
SECONDARY OBJECTIVES:
I. Vaccination related adverse events (AEs) (as determined by treated physician).
II. To comprehensively examine the host-virus immune monitoring, next generation sequencing and subsequent outcomes in patients with cancer who received COVID-19 vaccination will be studied to:
IIa. Identify cytokines/interferons and gene expression changes throughout the study period and assess their role as predictors/biomarkers for COVID-19 immune response and vaccine efficacy.
IIb. Determine the cell-mediated immune response to COVID-19 vaccination.
IIc. Develop and validate a risk-stratification algorithm to identify patients who would develop adequate response to COVID-19 vaccination versus those that will not.
IId. Determine the relationship of microbiome changes and predominance of certain species in response COVID-19 vaccination.
IIe. Correlate the changes in microbiome & metabolome to clinical outcomes following COVID-19 vaccination.
IIf. Identify vaccine efficacy against SARS-CoV-2 and other variants and prevention of severe clinical COVID-19 complications
IIg. Other biomarkers as to be determined.
OUTLINE:
Patients' medical charts are reviewed. Patients undergo collection of blood samples and nasal swabs as part of their standard of care on day 1 (1st vaccination), 2nd dose of vaccination, 14 days after 2nd dose of vaccination, as well as during their follow up visits at months 3-6, 6-12, and 12-18 if follow up is not done via telemedicine.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorKate Ida Lathrop