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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04854980
• Other study ID #: UMLT21037
• Status: Active, not recruiting
• Start date: August 3, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: July 31, 2024
• Est. primary completion date: March 15, 2022
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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