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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04854980
Other study ID # UMLT21037
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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