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

Completed

• Conditions: Covid19; Cancer
• Interventions: Other: Blood Sample

• Registration Number: NCT04854980
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Study Start: 2021-08-03
• Primary Completion: 2022-03-15
• Status Verified: 2023-09
• Study Completion: 2024-07-23
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental:	Blood Sample	Blood Sample Taken

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States