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
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
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.
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
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
Learn more about this trial
Immune Response to the COVID-19 Vaccine
We'll reach out to this number within 24 hrs