Status:
COMPLETED
Serologic Response to the SARS-CoV-2 (COVID-19) MRNA-1273 Vaccine in Select Subsets of Oncology Patients
Lead Sponsor:
University of Rochester
Conditions:
Covid19
Cancer
Eligibility:
All Genders
50-75 years
Brief Summary
To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.
Detailed Description
The purpose of this study is to measure the immune response to the COVID-19 vaccine in cancer patients and compare to the general population. This information can help optimize the timing of the mRNA-...
Eligibility Criteria
Inclusion
- Subjects are between 50 and 75 years of age;
- Have not had known or suspected infection with SARS-CoV-2 at any time;
- Subjects must fall into one of the following subsets of cancer patients:
- Localized prostate cancer on radiotherapy or have completed radiotherapy in the last three months
- Prostate cancer on androgen-deprivation therapy for biochemical recurrence
- Colon cancer on adjuvant chemotherapy for stage III disease
- CLL on a BTK inhibitor as a first-line single agent for at least 3 months
- Melanoma patients on adjuvant immunotherapy with PD-1 checkpoint inhibitors for at least 3 months
- Have received both doses of SARS-CoV-2 mRNA-1273 vaccine with proof of vaccination or are scheduled to do so;
- Have at least a one-year life expectancy;
- Prior radiation therapy is allowed, as long as it was completed more than 6 months prior to vaccination
Exclusion
- Subjects have a known hypersensitivity to a vaccine component;
- Have had known or suspected infection with SARS-CoV-2 at any time;
- Are organ transplant recipient on immunosuppression;
- Had received or are scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post second dose;
- Had received or are scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post second dose;
- Received high-dose corticosteroids at any time after receiving the vaccine;
- Are unable to give informed consent;
- Are receiving treatment for CLL with another agent (such as rituximab) in addition to a BTK inhibitor
Key Trial Info
Start Date :
August 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 23 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04854980
Start Date
August 3 2021
End Date
July 23 2024
Last Update
March 30 2025
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642