IRB Study Number 23-081
Status Recruiting
Institute Taussig Cancer Institute
Description
1.1 Primary Objective
Characterize the immunologic response following SARS-CoV-2 vaccination in children, adolescents, and young adults with cancer who are currently receiving or who recently completed treatment with immunosuppressive therapy.
Inclusion Criteria
3.2.1 Age
≥6 months and ≤37 years of age at time of enrollment.
3.2.2 COVID-19 Vaccine
Patient plans to receive their first COVID-19 vaccine dose using one of the FDA approved/FDA-EUA approved COVID-19 vaccines; OR
Patient already received their first COVID-19 vaccine dose ≤24 months prior to enrollment using one of the FDA approved/FDA-EUA approved COVID-19 vaccines.
Note: for this observational study, the decision to vaccinate is according to local discretion and should be made prior to consideration of enrollment.
3.2.3 Diagnosis
Must have a diagnosis of cancer.
3.2.4 Cancer Treatment
Patient must be undergoing or have previously received one of the following cancer treatments within 12 months before their first COVID-19 vaccine dose:
a. Dosing with chemotherapy or immunotherapy agent, including tyrosine kinase inhibitors and small molecule inhibitors targeting cancer.
b. Dosing with monoclonal antibodies targeting B-cell antigens (e.g. Rituximab), or Bruton tyrosine kinase inhibitors or Janus Kinase inhibitors.
c. Stem cell infusion for bone marrow transplant or CAR-T infusion for cellular therapy.
3.2.5 Timing
A patient enrolling prior to their first COVID-19 vaccine dose is eligible only if it is feasible to collect required baseline study specimens within protocol mandated time period prior to the initial COVID-19 vaccine dose; OR
A patient who already received a COVID-19 vaccine is eligible only if feasible to collect at least one post-first-dose follow-up specimen (i.e., at minimum, collection of the 24m PFD follow-up specimen must be feasible as per timing requirements in Section 4.2).
Note: for this observational study, the vaccine timing and regimen will proceed according to local discretion. Patients enrolled prior to their first COVID-19 vaccine dose who do not receive initial vaccine dose within 3 months after enrollment will be taken off study. See requirements for timing in Section 3.1.4 and see Section 5.2 for relevant off study criteria.
Exclusion Criteria
3.2.6 Prior Therapy
Documented SARS-CoV-2 monoclonal antibody infusion or convalescent plasma after COVID-19 infection within last 90 days.
Note: patients with previous COVID-19 infection are eligible as long as Section 3.2.6 requirements are met. Patients receiving IVIG therapy (i.e., post BMT or CART) are eligible.
3.2.7 Patients undergoing radiation therapy only are ineligible.
Reminder: before the planned or prior first dose of COVID-19 vaccine, patient must be undergoing or have received cancer treatments meeting criteria in Section 3.2.4.
