NCT05238467

Immunological Responses of COVID-19 Vaccination

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-05-21
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2022-02-14
• Last updated: 2023-02-21

Locations

1 site across 1 country: United States