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Immunological Responses of COVID-19 Vaccination

Sponsor
University Hospitals Cleveland Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05238467
Collaborator
(none)
100
Enrollment
1
Location
25.3
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: COVID antibody titers in the blood

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Immunological Responses of COVID-19 Vaccination in Cancer Patients on Chemotherapy: a Pilot Study
Actual Study Start Date :
May 21, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Seroprotection rate [05/2021-12/31/2022]

    had an antibody titer protective (1:40) at any point in testing

Secondary Outcome Measures

  1. Seroconversion rate [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

    1. 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.
    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106-5047

Sponsors and Collaborators

  • University Hospitals Cleveland Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alberto J. Montero, Professor of Medicine, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT05238467
Other Study ID Numbers:
  • CASE 3Y21
First Posted:
Feb 14, 2022
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Antibodies

Study Results

No Results Posted as of Feb 14, 2022