Host Immune Response to Novel RNA COVID-19 Vaccination

NCT04784689 | Completed DMC

• 1 other identifier: CTMS 21-0012
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19 Vaccine; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Prospective - Cancer Patients that have received COVID-19 Vaccination

Biological: COVID-19 Vaccine

Interventions

COVID-19 Vaccine BIOLOGICAL

COVID-19 Vaccine

Prospective - Cancer Patients that have received COVID-19 Vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mays Cancer Center patients eligible to receive the COVID-19 vaccination.

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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Dimpy Shah, MD PhD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: February 24, 2021
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

US (1)