Immunological Responses of COVID-19 Vaccination

February 17, 2023 updated by: Alberto J. Montero, University Hospitals Cleveland Medical Center

Long Term Immunological Responses of COVID-19 Vaccination in Cancer Patients on Chemotherapy: a Pilot Study

Cancer patients with COVID-19 have a 30% higher mortality rate compared to the general population and are considered a high-risk group by the American Association for Cancer Research that should be given "high priority" during COVID-19 vaccine administration. Although studies have suggested that vaccination during active treatment with chemo and/or radiation therapy provides suboptimal antibody response, the studies were underpowered and heterogeneous thus putting this conclusion into question. We need data in cancer patients on immunosuppressive chemotherapy at the time of COVID vaccination to understand how immune responses compare to healthy controls and cancer patients not on immunosuppressive therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5047
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group A will consist of 50 participants with a diagnosis of one of the following cancers: breast, colorectal, or prostate cancers who received myelosuppressive cytotoxic chemotherapy at the time of COVID vaccination, or who received chemotherapy within 30 days prior to the initial or booster vaccination, or who started on chemotherapy within 30 days after the initial or booster COVID vaccination. Group B will consist of 25 participants with a diagnosis of breast, colorectal, or prostate cancers who are on non-myelosuppressive treatment including endocrine therapy, tyrosine kinase inhibitor or anti-HER 2 therapy. Group C will consist of 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and >12 months from completion of chemotherapy or radiation.

Description

Inclusion Criteria:

  • Participants must meet all of the following inclusion criteria to be eligible for enrollment:

    1. Willing and able to provide written informed consent for the trial.
    2. Male or female participants >18 years of age on the day of signing informed consent.
    3. a. Participants (>18 years) with gastrointestinal (gastroesophageal, pancreatic, small bowel, colon, anal) solid tumors, breast, or prostate cancers who received myelosuppressive chemotherapy within 60 days prior to initial or booster COVID vaccination, or who started on chemotherapy within 60 days after the initial or booster COVID vaccination; or b. Adult participants (>18 years) not receiving chemotherapy at the time of initial or booster COVID vaccination, but who were on non-immunosuppressive treatments (endocrine therapy, treatment with tyrosine kinase inhibitor or antiHER-2 therapy); or c. Adult participants > 18 years either: (i) with no history of cancer or (ii) prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and >12 months from completion of chemotherapy or radiation.
    4. a. Participants in groups A and B who have a planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine, or previous COVID vaccination within 90 days from study enrollment are eligible provided they meet all other above eligibility criteria; or b. Participants in group C who have planned COVID vaccination within the next 90 days of study enrollment with any FDA approved vaccine; or previous COVID vaccination within six months from study enrollment are eligible provided they meet all other above eligibility criteria

Exclusion Criteria:

  • Participants will be considered ineligible for enrollment with the following criteria:

    1. Participants currently on immunotherapy
    2. Participants with documented COVID 19 infection within < 6 months from study enrollment
    3. Prior history of autoimmune disorder and are currently on immunosuppressive therapy or have received immunosuppressive therapy within the last 6-12 months prior to enrollment
    4. No planned and no prior COVID vaccination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Group A will consist of 50 participants with a diagnosis of one of the following cancers: breast, colorectal, or prostate cancers who received myelosuppressive cytotoxic chemotherapy at the time of COVID vaccination, or who received chemotherapy within 30 days prior to the initial or booster vaccination, or who started on chemotherapy within 30 days after the initial or booster COVID vaccination. Cytotoxic chemotherapy can be given either in the neoadjuvant/adjuvant setting or metastatic setting.
Other: COVID antibody titers in the blood
COVID antibody titers will be quantitatively assessed at baseline, 8 weeks and approximately 6, 9, and 12 months from date of study enrollment. Titers will be compared to levels in 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent,.and in 25 age matched cancer participants who are on non-immunosuppressive treatments as defined below.
B
Group B will consist of 25 participants with a diagnosis of breast, colorectal, or prostate cancers who are on non-myelosuppressive treatment including endocrine therapy, tyrosine kinase inhibitor or anti-HER 2 therapy.
Other: COVID antibody titers in the blood
COVID antibody titers will be quantitatively assessed at baseline, 8 weeks and approximately 6, 9, and 12 months from date of study enrollment. Titers will be compared to levels in 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent,.and in 25 age matched cancer participants who are on non-immunosuppressive treatments as defined below.
C
Group C will consist of 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent, without evidence of disease recurrence, and >12 months from completion of chemotherapy or radiation.
Other: COVID antibody titers in the blood
COVID antibody titers will be quantitatively assessed at baseline, 8 weeks and approximately 6, 9, and 12 months from date of study enrollment. Titers will be compared to levels in 25 age matched adult participants with no prior history of cancer or prior history of non-metastatic solid cancer invasive cancer treated with a curative intent,.and in 25 age matched cancer participants who are on non-immunosuppressive treatments as defined below.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprotection rate
Time Frame: 05/2021-12/31/2022
had an antibody titer protective (1:40) at any point in testing
05/2021-12/31/2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroconversion rate
Time Frame: 05/2021-12/31/2022
the proportion of participants who had an antibody titer fourfold increase in their antibody titer to 1:40 or greater after vaccination over baseline
05/2021-12/31/2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Actual)

February 13, 2023

Study Completion (Actual)

February 13, 2023

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20210455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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