
Phase 1 Studies: AVX-001 and AVX-001-EXT
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PVX108 has been studied in AVX-001, a First in Human Phase 1 randomised double blind clinical trial to evaluate the safety and tolerability of PVX108 administered intradermally in adult participants with peanut allergy. The trial comprised 2 stages: a single ascending dose in 8 cohorts and a multiple dose stage in which participants received 6 doses over 16 weeks. During the study, participants were monitored for safety and tolerability and samples were collected for biomarker and immunological studies.
AVX-001-EXT was a follow-up study to AVX-001. Participants who completed Stage 2 in the AVX-001 study were followed up at Month 18. Blood samples taken for immunological and biomarker studies.
The studies demonstrated that PVX108 was safe and well tolerated in participants with peanut allergy, including participants with asthma. Biomarker and immunological studies demonstrated directional immunological changes which are relevant to the induction of tolerance to peanut protein.
Phase 2 Studies: AVX-201
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AVX-201 is a double blind randomised Phase 2 study in adolescents and children with peanut allergy. The aims of the trial are to evaluate the efficacy and safety of PVX108 when administered intradermally in monthly doses over a 12 month period. An FDA IND is now open and the trial has been initiated in Australia. Sites in the United States are anticipated to open towards the end of the year.
Are you interested in participating in AVX-201?
Australia
South Australia
Currently Recruiting
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Women's and Children's Hospital, Adelaide
North Adelaide, SA 5006
Victoria
Currently Recruiting
Murdoch Children's Research Institute,
Royal Children's Hospital
Melbourne Parkville, VIC 3052
Email: aravax.peanut@mcri.edu.au
Western Australia
Currently Recruiting
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Perth Children's Hospital
Nedlands, WA 6009
New South Wales
Currently Recruiting
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Children's Hospital at Westmead
Westmead, NSW 2145
Email: SCHN-CHW-AllergyResearch@health.nsw.gov.au
Not yet recruiting
Sydney Children's Hospital
Randwick, NSW 2031
United States
Arkansas
Not yet recruiting
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Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
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Maryland
Not yet recruiting
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Johns Hopkins Hospital
Baltimore, Maryland, 21205
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California
Not yet recruiting
Peninsula Research Associates
Rolling Hills Estates, California, 90274
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Massachusetts
Not yet recruiting
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Massachusetts General Hospital
Boston, Massachusetts, 02114
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Georgia
Not yet recruiting
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Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
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North Carolina
Not yet recruiting
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
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