Immune Response to the COVID-19 Vaccine

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

Detailed Description
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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.

Official Title
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Immune Response to the COVID-19 Vaccine

Conditions
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Malignancy, Covid19, Cancer, Vaccine Response Impaired

Intervention / Treatment
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* Biological: SARS-COV2 Pfizer Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have active solid tumor malignancy diagnosis On active chemotherapy Received two prior SARS-COV2 Pfizer vaccines Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent Agree to comply with study procedures Subjects previously enrolled under the main study Exclusion Criteria: History of HIV or organ/bone marrow transplant Actively receiving immunotherapy On active, chronic immunosuppression (>10 mg daily dose of prednisone equivalent) Currently incarcerated or residence of another state Speaks a language other than English.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3rd COVID-19 vaccine (2nd booster)<br>Patients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine. | Biological: SARS-COV2 Pfizer Vaccine<br>* Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19 vaccine, Pfizer Covid-a9 vaccine, Covid vaccine study