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Immune Response to the COVID-19 Vaccine

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ClinicalTrials.gov Identifier: NCT04936997
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE June 18, 2021
First Posted Date  ICMJE June 23, 2021
Last Update Posted Date June 28, 2021
Actual Study Start Date  ICMJE June 7, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Response to the COVID-19 Vaccine
Official Title  ICMJE Immune Response to the COVID-19 Vaccine
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Cancer
  • Malignancy
  • Vaccine Response Impaired
Intervention  ICMJE 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).
Study Arms  ICMJE 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.
Intervention: Biological: SARS-COV2 Pfizer Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2021)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Pennington, BS (520) 694-9065 danielpennington@arizona.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04936997
Other Study ID Numbers  ICMJE 2012325795-B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachna Shroff, MD University of Arizona
PRS Account University of Arizona
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP