Immunological Responses of COVID-19 Vaccination

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.

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Key information

Conditions

Cancer; Chemotherapy Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-5047, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Willing and able to provide written informed consent for the trial.
Male or female participants >18 years of age on the day of signing informed consent.
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.
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:

Participants currently on immunotherapy
Participants with documented COVID 19 infection within < 6 months from study enrollment
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
No planned and no prior COVID vaccination

Treatment and study plan

COVID antibody titers in the blood

Other

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.

Primary outcomes

Seroprotection rate

Time frame: 05/2021-12/31/2022

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Feb 14, 2022
Registry last updated: Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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