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

NCT04854980 | Completed

• 1 other identifier: UMLT21037
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19; Cancer

Keywords

Covid19; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental:

Blood Sample Taken

Other: Blood Sample

Interventions

Blood Sample OTHER

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.

Experimental:

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are between 50 and 75 years of age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

COVID-19; Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: August 3, 2021
• Primary Completion: March 15, 2022
• Study Completion: July 23, 2024
• Last Updated: March 30, 2025

Record last verified: 2023-09

Locations

US (1)