Evaluating immune response to vaccines in pediatric cancer survivors
Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer
This study tests how well booster vaccines or full revaccination help improve the immune response in kids who have survived cancer compared to their healthy siblings.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 2 Years to 21 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT04948619 on ClinicalTrials.gov |
What this trial studies
This study investigates immune dysfunction in pediatric cancer survivors after completing cancer-directed therapy. It focuses on assessing infection rates and immune responses by comparing these survivors to healthy siblings. The trial involves a randomized approach where patients will receive either booster vaccines or a full revaccination series starting three months post-therapy. Immune function will be evaluated at multiple time points to determine the effectiveness of the vaccination strategies employed.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 2 to 21 who have completed cancer-directed systemic therapy for any malignancy.
Not a fit: Patients who have not undergone cancer-directed systemic therapy or those treated solely with observation, surgery, or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies and improve immunity in pediatric cancer survivors, reducing their risk of serious infections.
How similar studies have performed: Other studies have shown promising results in improving immune responses through tailored vaccination strategies in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 30 days prior to date of enrollment 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 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
Where this trial is running
Charlotte, North Carolina
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ashley Hinson, MD — Wake Forest University Health Sciences
- Study coordinator: Sceria Jenkins, RN
- Email: Sceria.Jenkins@advocatehealth.org
- Phone: 980-442-2323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.