To explore the immune response to the COVID-19 vaccine in cancer patients and compare tothe general population.
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.
Other: Blood Sample
Blood sample, 2- to 5 tea spoon full (between 10 to 25 mL approximately) between 43 to 96
days after first dose of the vaccine.
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
University of Rochester
Rochester, New York, United States
Not Provided