PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD

NCT Number	NCT05096481
Lead Sponsor	Nationwide Children's Hospital Collaborators: Duke University
Conditions	High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma
Enrollment	120 participants
Start Date	2024-07-18
Primary Completion	2028-06-15 (estimated)
Study Completion	2030-06-15 (estimated)
Updated on ClinicalTrials.gov	2026-05-11