Immune Response to the COVID-19 Vaccine

• Sponsor: University of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT04936997
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 11
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19; Cancer; Malignancy; Vaccine Response Impaired	Biological: SARS-COV2 Pfizer Vaccine	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Immune Response to the COVID-19 Vaccine
• Actual Study Start Date: Jun 7, 2021
• Actual Primary Completion Date: Aug 25, 2021
• Actual Study Completion Date: May 8, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Immune response [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.

Secondary Outcome Measures

1. Adverse events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85719

Sponsors and Collaborators

• University of Arizona

Investigators

• Principal Investigator: Rachna Shroff, MD, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Arizona
• ClinicalTrials.gov Identifier: NCT04936997
• Other Study ID Numbers: 2012325795-B
• First Posted: Jun 23, 2021
• Last Update Posted: May 20, 2022
• Last Verified: May 1, 2022

• 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
• Keywords provided by University of Arizona: Covid-19 vaccine; Pfizer Covid-a9 vaccine; Covid vaccine study
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of May 20, 2022