PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma (NCT05096481)
Phase 2 Trial of a Novel Peptide Vaccine (PEP-CMV) Targeting CMV Antigen for Newly Diagnosed Pediatric High-grade Glioma and Diffuse Intrinsic Pontine Glioma and Recurrent Medulloblastoma
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Colorado — Aurora, Colorado
Age range: 3 Years to 39 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Children's Hospital Colorado — Aurora, Colorado
- Children's National Medical Center — Washington D.C., District of Columbia
- Nicklaus Children's Hospital — Miami, Florida
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Dana-Farber Cancer Institute — Boston, Massachusetts
- C.S. Mott Children's Hospital — Ann Arbor, Michigan
- St. Louis Children's Hospital — St Louis, Missouri
- Duke Cancer Center — Durham, North Carolina
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Texas Children's Hospital — Houston, Texas
- Seattle Children's Hospital — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (614) 722-3284
Email: kelsey.troyer@nationwidechildrens.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in High Grade Glioma
- Study of DSP-0390 in Patients With Recurrent High-Grade Glioma — San Francisco, California
- Circulating Tumor DNA Collection From Patients With High Grade Gliomas — Toronto, Ontario
- A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma — Aurora, Colorado
- Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors — Aurora, Colorado
- MRI in High-Grade Glioma Patients Undergoing Chemoradiation — Winston-Salem, North Carolina
Explore by condition: All High Grade Glioma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.