Status:
COMPLETED
Host Immune Response to Novel RNA COVID-19 Vaccination
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
COVID-19 Vaccine
Cancer
Eligibility:
All Genders
18+ years
Brief Summary
To determine the antibody response level in patients with cancer to the COVID-19 vaccination.
Eligibility Criteria
Inclusion
- Age 18 years or older
- Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
- Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
- Able to provide informed consent
- Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.
Exclusion
- Previously documented COVID infection
- Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
- Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:
- Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
- Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol \[PEG\])
- Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
- Pregnant or breastfeeding
- Unable to comply with study related procedures as determined by the study team.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04784689
Start Date
February 24 2021
End Date
May 18 2022
Last Update
May 25 2023
Active Locations (1)
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1
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, United States, 78229