Cancer, Covid19, Malignancy, Vaccine Response Impaired
Conditions
Keywords
Covid-19 vaccine, Pfizer Covid-a9 vaccine, Covid vaccine study
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.
Interventions
BIOLOGICALSARS-COV2 Pfizer Vaccine
Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed