Recruiting
Phase 2

Immune Function

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04948619

Conditions

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

Interventions

Vaccine

Study Details

Brief summary:

Pediatric cancer survivors have increased infection-related morbidity and mortality. This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable. The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors.

Conditions

Pediatric Cancer

Study ID

NCT04948619

Start date

Aug 8, 2022

Status verified date

Jul, 2026

Completion date

Oct, 2030

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
2. Age greater than or equal to 2 years and less than 22 years at the time of consent
3. Lansky/Karnofsky Performance Status of greater than 50 (ECOG less than 2) within 60 days prior to date of enrollment/randomization
4. Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital
5. History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy
6. Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment/randomization
7. As determined by the enrolling physician, ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study

Exclusion Criteria:

1. Malignant disease treated with observation, surgery, or radiotherapy alone
2. Known coexisting immunodeficiency
3. Subjects with normal baseline titers for all investigated vaccines
4. Known pregnancy
5. Documented previous severe allergic reaction to any vaccine or component of a vaccine
6. Documented current/active, severe infection, as determined by the investigator

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Arm A - Single booster vaccines

Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. Boosters for live vaccines will be given at the 6 month visit. Boosters will only be given as applicable for low titers tested at the baseline assessment visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.

other: Arm B - Staged revaccination series

Those subjects randomized to Arm B, the full revaccination series, will receive applicable vaccines when titers are low (below normal range) at baseline. When indicated, non-live vaccines will be given at the 3, 6, and 9 month visits, live vaccines will be given at the 6 and 9 month visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.

Interventions

Vaccine

Patients will have lab evaluations for immune function at baseline, 3, 6, 9 and 24 months post completion of treatment. At 3 months off therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies.

Primary outcome measure

  • Vaccination comparison via objective lab measurements of vaccine titers [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Pediatric Oncology
  • Vaccine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-23.