Immune Response to the COVID-19 Vaccine

Early Phase 1

Completed

• Conditions: Cancer; Malignancy; Covid19; Vaccine Response Impaired
• Interventions: Biological: SARS-COV2 Pfizer Vaccine

• Registration Number: NCT04936997
• Lead Sponsor: University of Arizona

Brief 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.

Study Timeline

• Study Start: 2021-06-07
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-23
• Primary Completion: 2021-08-25
• Status Verified: 2022-05
• Study Completion: 2022-05-08
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients must have active solid tumor malignancy diagnosis
2. On active chemotherapy
3. Received two prior SARS-COV2 Pfizer vaccines
4. Age ≥ 18 years
5. Ability to understand and the willingness to sign a written informed consent
6. Agree to comply with study procedures
7. Subjects previously enrolled under the main study

Exclusion Criteria

1. History of HIV or organ/bone marrow transplant
2. Actively receiving immunotherapy
3. On active, chronic immunosuppression (>10 mg daily dose of prednisone equivalent)
4. Currently incarcerated or residence of another state
5. Speaks a language other than English.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3rd COVID-19 vaccine (2nd booster)	SARS-COV2 Pfizer Vaccine	Patients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine.

Primary Outcome Measures

Name	Time	Method
Immune response	3 months	Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by antibody quantification in blood samples.

Secondary Outcome Measures

Name	Time	Method
Adverse events	3 months	Evaluating immune response to a second COVID-19 vaccination booster (3rd vaccine) in patients with solid tumor malignancies on immunosuppressive cancer therapies by T-cell quantification in blood samples.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States