Host Immune Response to Novel RNA COVID-19 Vaccination

Completed

• Conditions: COVID-19 Vaccine; Cancer
• Interventions: Biological: COVID-19 Vaccine

• Registration Number: NCT04784689
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-24
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Primary Completion: 2022-05-18
• Study Completion: 2022-05-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective - Cancer Patients that have received COVID-19 Vaccination	COVID-19 Vaccine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mays Cancer Center, UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States