Immune Response to the COVID-19 Vaccine

May 19, 2022 updated by: University of Arizona
Explore the effects on immune response to include a potential third vaccine for the cancer cohort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Biological: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 7, 2021

Primary Completion (ACTUAL)

August 25, 2021

Study Completion (ACTUAL)

May 8, 2022

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (ACTUAL)

June 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012325795-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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