Immune Response to the COVID-19 Vaccine

Cancer Clinical Trial

Official title:

Immune Response to the COVID-19 Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936997
• Other study ID #: 2012325795-B
• Status: Completed
• Phase: Early Phase 1
• Start date: June 7, 2021
• Est. completion date: May 8, 2022

Study information

• Verified date: May 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 8, 2022
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• COVID-19
• Covid19
• Malignancy
• Vaccine Response Impaired

Intervention

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).

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months