Host Immune Response to Novel RNA COVID-19 Vaccination
Study Details
Study Description
Brief Summary
To determine the antibody response level in patients with cancer to the COVID-19 vaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prospective - Cancer Patients that have received COVID-19 Vaccination
|
Biological: COVID-19 Vaccine
COVID-19 Vaccine
|
Outcome Measures
Primary Outcome Measures
- Antibody response level in patients with cancer to the COVID-19 vaccination. [Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months]
Antibody response change over time
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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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)
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Able to provide informed consent
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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 Criteria:
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Previously documented COVID infection
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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)
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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:
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Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
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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])
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Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
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Pregnant or breastfeeding
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Unable to comply with study related procedures as determined by the study team.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mays Cancer Center, UT Health San Antonio | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- The University of Texas Health Science Center at San Antonio
Investigators
- Principal Investigator: Dimpy Shah, MD PhD, University of Texas Health Science Center San Antonio
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTMS 21-0012