Host Immune Response to Novel RNA COVID-19 Vaccination

Completed

Conditions studied: COVID-19 Vaccine, Cancer

In brief

To determine the antibody response level in patients with cancer to the COVID-19 vaccination.

Key facts

Study ID

NCT04784689

Run by

The University of Texas Health Science Center at San Antonio

People needed

50

Starts

2021-02-24

Expected to finish

2022-05-18

Last updated by the study team

2023-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mays Cancer Center, UT Health San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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