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

September 5, 2023 updated by: Deepak Sahasrabudhe, University of Rochester

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects are between 50 and 75 years of age

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental:
Blood Sample Taken
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2021

Primary Completion (Actual)

March 15, 2022

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMLT21037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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