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Immune Response to the COVID-19 Vaccine

Primary Purpose

Covid19, Cancer, Malignancy

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
SARS-COV2 Pfizer Vaccine
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Covid-19 vaccine, Pfizer Covid-a9 vaccine, Covid vaccine study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Arizona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3rd COVID-19 vaccine (2nd booster)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 18, 2021
Last Updated
May 19, 2022
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT04936997
Brief Title
Immune Response to the COVID-19 Vaccine
Official Title
Immune Response to the COVID-19 Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
May 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Cancer, Malignancy, Vaccine Response Impaired
Keywords
Covid-19 vaccine, Pfizer Covid-a9 vaccine, Covid vaccine study

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3rd COVID-19 vaccine (2nd booster)
Arm Type
Experimental
Arm Description
Patients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine.
Intervention Type
Biological
Intervention Name(s)
SARS-COV2 Pfizer Vaccine
Intervention Description
Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Primary Outcome Measure Information:
Title
Immune response
Description
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 Outcome Measure Information:
Title
Adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachna Shroff, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34594036
Citation
Shroff RT, Chalasani P, Wei R, Pennington D, Quirk G, Schoenle MV, Peyton KL, Uhrlaub JL, Ripperger TJ, Jergovic M, Dalgai S, Wolf A, Whitmer R, Hammad H, Carrier A, Scott AJ, Nikolich-Zugich J, Worobey M, Sprissler R, Dake M, LaFleur BJ, Bhattacharya D. Immune responses to two and three doses of the BNT162b2 mRNA vaccine in adults with solid tumors. Nat Med. 2021 Nov;27(11):2002-2011. doi: 10.1038/s41591-021-01542-z. Epub 2021 Sep 30.
Results Reference
derived

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Immune Response to the COVID-19 Vaccine

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