Serologic Response to the SARS-CoV-2 (COVID-19) MRNA-1273 Vaccine in Select Subsets of Oncology Patients
Purpose
To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.
Conditions
- Covid19
- Cancer
Eligibility
- Eligible Ages
- Between 50 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Experimental: | Blood Sample Taken |
|
Recruiting Locations
More Details
- NCT ID
- NCT04854980
- Status
- Completed
- Sponsor
- University of Rochester
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-1273 vaccine relative to starting treatment for cancer, adding booster immunizations or incorporation of medications that to enhance the immune response.