Immune Response to the COVID-19 Vaccine
1 other identifier
interventional
20
1 country
1
Brief Summary
Explore the effects on immune response to include a potential third vaccine for the cancer cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 covid19
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2021
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2022
CompletedMay 20, 2022
May 1, 2022
3 months
June 18, 2021
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse events
3 months
Study Arms (1)
3rd COVID-19 vaccine (2nd booster)
EXPERIMENTALPatients who were a part of the non-interventional portion of the study are eligible to receive a third COVID-19 Pfizer vaccine.
Interventions
Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona
Tucson, Arizona, 85719, United States
Related Publications (1)
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.
PMID: 34594036DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachna Shroff, MD
University of Arizona
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 23, 2021
Study Start
June 7, 2021
Primary Completion
August 25, 2021
Study Completion
May 8, 2022
Last Updated
May 20, 2022
Record last verified: 2022-05