Immune Response to the COVID-19 Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2022-05-08

Brief Summary

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

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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.

Conditions

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Covid19 Cancer Malignancy Vaccine Response Impaired

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3rd COVID-19 vaccine (2nd booster)

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

Group Type EXPERIMENTAL

SARS-COV2 Pfizer Vaccine

Intervention Type BIOLOGICAL

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

Interventions

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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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No