Host Immune Response to Novel RNA COVID-19 Vaccination

Cancer Clinical Trial

Official title:

Host Immune Response to Novel RNA COVID-19 Vaccination in Patients With Cancer (CTMS# 21-0012)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784689
• Other study ID #: CTMS 21-0012
• Status: Completed
• Start date: February 24, 2021
• Est. completion date: May 18, 2022

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 18, 2022
• Est. primary completion date: May 18, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• COVID-19
• COVID-19 Vaccine

Intervention

Biological:
• COVID-19 Vaccine
COVID-19 Vaccine

Locations

Country	Name	City	State
United States	Mays Cancer Center, UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody response level in patients with cancer to the COVID-19 vaccination.	Antibody response change over time	Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months