Immune Response to the COVID-19 Vaccine

Early Phase 1CompletedNCT04936997

University of Arizona20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19 Cancer Malignancy Vaccine Response Impaired

Interventions

SARS-COV2 Pfizer VaccineBIOLOGICAL

Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Arizona

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Immune response

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.

Time frame: 3 months

Secondary Outcomes

Adverse events

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.

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.