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

NCT ID: NCT04854980

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-03
• Study Completion Date: 2024-07-23

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.

Conditions

Covid19; Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental:

Blood Sample Taken

Blood Sample

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Deepak Sahasrabudhe

Professor - Department of Medicine , Hematology/Oncology (SMD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

UMLT21037

Identifier Type: -

Identifier Source: org_study_id