🏛️ Verified NIH Record • Updated 2026-08-20

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Nationwide Children's Hospital

🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (67 items) and avoid the listed exclusions (16 items).

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 Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria for all strata:
  • Pregnancy or Breast-Feeding:
  • Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-monarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after drug cessation.
  • Study Specific:
  • Active infection requiring treatment
  • Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history
  • Known immunosuppressive disease
  • Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or moderate to severe pulmonary problems generally defined by need for medical intervention (e.g., oxygen, medications) and/or limiting activities of daily living (generally CTCAE Grade 2 or higher) or shortness of breath with limited exertion are not eligible. Pulmonary conditions include (but are not limited to) COPD, asthma, and hemi-pneumectomy
  • Patients receiving concomitant immunosuppressive agents for medical conditions; inhaled corticosteroids for asthma are allowed.
  • Patients receiving concomitant tumor-directed therapy
  • Patients receiving any other investigational drug therapy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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.
  • 💵 Compensation indicated: Patients will receive one course of temozolomide 200 mg/m2/day x 5 days on Days 1-5 of cycle 1 and receive PEP-CMV vaccine intradermally at dose level 1 (250 μg/m2 ) on Days 21, 35 ±2 days, and 49 ...

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗