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

Serologic Response to the SARS-CoV-2 MRNA-1273 Vaccine in Select Subsets of Oncology Patients - a Pilot Study

To explore the immune response to the COVID-19 vaccine in cancer patients and compare to the 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.

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