Cancer, Covid19
Conditions
Keywords
Covid19, Cancer
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-1273 vaccine relative to starting treatment for cancer, adding booster immunizations or incorporation of medications that to enhance the immune response.
Interventions
OTHERBlood 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.
Sponsors
University of Rochester
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunological response to the vaccine | 1 year | Vaccine response, as determined by blood concentrations of serum IgG reactive to the RBD domain of spike protein from the original SARS-CoV-2 virus will be measured by ELISA |
Countries
United States
Outcome results
None listed