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Immunological Responses of COVID-19 Vaccination

NCT05238467 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2023-02-21

No results posted yet for this study

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.

Conditions

  • Cancer; Chemotherapy

Interventions

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.

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2023-02-13
Completion
2023-02-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238467 on ClinicalTrials.gov