Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer

Recruiting at 73 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

549 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or "boosts" (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.

Research Team

Emad K Salman

Principal Investigator

Children's Oncology Group

Eligibility Criteria

Inclusion Criteria

>= 6 months and =< 37 years of age at time of enrollment

Patient plans to receive one of the food and drug administration (FDA) approved/FDA-emergency use authorization (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

Treatment Details

Interventions

• COVID-19 Vaccine

Participant Groups

Group I: Observational (survey, biospecimen collection) Experimental Treatment 2 Interventions

Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+