Host Immune Response to Novel RNA COVID-19 Vaccination

The University of Texas System (UT)

Status: Completed

Conditions: COVID-19 Vaccine; Cancer

Treatments: Biological: COVID-19 Vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04784689

CTMS 21-0012

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. 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
3. 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)
4. Able to provide informed consent
5. 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

1. Previously documented COVID infection

2. 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)

3. 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)

4. Pregnant or breastfeeding

5. Unable to comply with study related procedures as determined by the study team.

Trial design

50 participants in 1 patient group

Prospective - Cancer Patients that have received COVID-19 Vaccination

Treatment:

Biological: COVID-19 Vaccine