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

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT04854980
Collaborator
(none)
55
Enrollment
1
Location
11.9
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Sample

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 Design

Study Type:
Observational
Anticipated Enrollment :
55 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Serologic Response to the SARS-CoV-2 mRNA-1273 Vaccine in Select Subsets of Oncology Patients - A Pilot Study
Actual Study Start Date :
Aug 3, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Rochester New York United States 14642

Sponsors and Collaborators

  • University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deepak Sahasrabudhe, Professor - Department of Medicine , Hematology/Oncology (SMD), University of Rochester
ClinicalTrials.gov Identifier:
NCT04854980
Other Study ID Numbers:
  • UMLT21037
First Posted:
Apr 22, 2021
Last Update Posted:
Aug 10, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Deepak Sahasrabudhe, Professor - Department of Medicine , Hematology/Oncology (SMD), University of Rochester
Covid19
Cancer
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 10, 2021