A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Condition(s) studied
Investigational drug(s) / intervention(s)
PVX-108: PVX108 comprises a mixture of peptides that represent sequences from peanut allergens
Placebo: Matching placebo comprises the formulation vehicle without peptides
Study summary
The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with peanut allergy.
Eligibility
Primary outcome measure(s)
- Ratio of maximum tolerated dose (MTD) of peanut protein at the Week 46 double blind placebo-controlled food challenge (DBPCFC) relative to baseline in children aged 4 to 11 years treated with PVX108 compared to placebo — 46 weeks
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Arkansas Children's Research Institute | Little Rock | Arkansas | |
| Peninsula Research Associates | Rolling Hills Estates | California | |
| Children's Healthcare of Atlanta | Atlanta | Georgia | |
| Riley Children's Hospital at IU | Indianapolis | Indiana | |
| Johns Hopkins Hospital | Baltimore | Maryland | |
| IAA Clinical Research | Chevy Chase | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | |
| Sydney Children's Hospital | Randwick | New South Wales | |
| The Children's Hospital at Westmead | Westmead | New South Wales | |
| Queensland Children's Hospital | South Brisbane | Queensland | |
| Women's and Children's Hospital | North Adelaide | South Australia | |
| The Royal Children's Hospital Melbourne | Parkville | Victoria | |
| Perth Children's Hospital | Nedlands | Western Australia |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05621317 on ClinicalTrials.gov ↗ ← All trials in the USA