NCT04936997

Immune Response to the COVID-19 Vaccine

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Explore the effects on immune response to include a potential third vaccine for the cancer cohort.

Detailed description

In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.

Conditions

• Covid19
• Cancer
• Malignancy
• Vaccine Response Impaired

Interventions

Type	Name	Description
BIOLOGICAL	SARS-COV2 Pfizer Vaccine	Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Timeline

• Start date: 2021-06-07
• Primary completion: 2021-08-25
• Completion: 2022-05-08
• First posted: 2021-06-23
• Last updated: 2022-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study