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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-24)

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

๐ŸŸข Recruiting Phase 2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Nationwide Children's Hospital

๐Ÿฉบ Protocol Summary

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

Primary Research Facility: Children's Hospital Colorado (Aurora, Colorado)

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๐Ÿ“ Primary Site Map

Site: Children's Hospital Colorado โ€” Aurora, Colorado

๐Ÿ“ All Participating Trial Locations (13 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Children's Hospital Colorado โ€” Aurora, Colorado โ€ข Contact: (720) 777-0461
2. Children's National Medical Center โ€” Washington D.C., District of Columbia โ€ข Contact: (202) 476-5046
3. Nicklaus Children's Hospital โ€” Miami, Florida โ€ข Contact: (305) 662-8360
4. Ann & Robert H. Lurie Children's Hospital of Chicago โ€” Chicago, Illinois โ€ข Contact: (312) 227-4090
5. Dana-Farber Cancer Institute โ€” Boston, Massachusetts โ€ข Contact: (617) 632-4309
6. C.S. Mott Children's Hospital โ€” Ann Arbor, Michigan โ€ข Contact: (866) 909-4449
7. St. Louis Children's Hospital โ€” St Louis, Missouri
8. Duke Cancer Center โ€” Durham, North Carolina โ€ข Contact: (919) 684-5013
9. Cincinnati Children's Hospital Medical Center โ€” Cincinnati, Ohio โ€ข Contact: (513) 517-2068
10. Nationwide Children's Hospital โ€” Columbus, Ohio โ€ข Contact: (614) 722-6039
11. Children's Hospital of Philadelphia โ€” Philadelphia, Pennsylvania โ€ข Contact: (215) 590-5188
12. Texas Children's Hospital โ€” Houston, Texas โ€ข Contact: (832) 824-4681
13. Seattle Children's Hospital โ€” Seattle, Washington โ€ข Contact: (206) 987-2106

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05096481 โ€ข Last Synced: 2026-08-24
View on ClinicalTrials.gov โ†—
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