Serologic Response to the SARS-CoV-2 (COVID-19) mRNA-1273 Vaccine in Select Subsets of Oncology Patients

Study Overview
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Brief Summary
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To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the general population.

Detailed Description
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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.

Official Title
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Serologic Response to the SARS-CoV-2 mRNA-1273 Vaccine in Select Subsets of Oncology Patients - A Pilot Study

Conditions
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Covid19, Cancer

Intervention / Treatment
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* Other: Blood Sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental:<br>Blood Sample Taken | Other: Blood Sample<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological response to the vaccine | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Cancer