Immune Response to the COVID-19 Vaccine

University of Arizona

Status and phase: Completed; Early Phase 1

Conditions: Vaccine Response Impaired; Covid19; Cancer; Malignancy

Treatments: Biological: SARS-COV2 Pfizer Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04936997

2012325795-B

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

3rd COVID-19 vaccine (2nd booster)

Experimental group

Description:

Patients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine.

Treatment:

Biological: SARS-COV2 Pfizer Vaccine