Serologic Response to the SARS-CoV-2 (COVID-19) MRNA-1273... | NCT04854980

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

NCT04854980

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Mar 30, 2025Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Covid19
Cancer

Interventions

Blood Sample

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2021Actual

Primary Completion Date

Mar 15, 2022Actual

Completion Date

Jul 23, 2024Actual

First Submitted Date

Apr 20, 2021

First Submission Date that Met QC Criteria

Apr 20, 2021

First Posted Date

Apr 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2025

Last Update Posted Date

Mar 30, 2025Actual

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
Experimental:		Blood Sample Taken	Other: Blood Sample

Name	Type	Description	Arm Group Labels	Other Names
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:

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects are between 50 and 75 years of age

Sampling Method

Non-Probability Sample

ID	Term
D000086382	COVID-19
D009369	Neoplasms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis