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OpenTrials
Completed

NCT Number: NCT04784689

Host Immune Response to Novel RNA COVID-19 Vaccination

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

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Key information

Conditions

COVID-19 Vaccine Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

COVID-19 vaccine

Biological

COVID-19 Vaccine

Primary outcomes

  1. Antibody response level in patients with cancer to the COVID-19 vaccination.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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