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Phase 1 Studies: AVX-001 and AVX-001-EXT

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

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

Women's and Children's Hospital, Adelaide

North Adelaide, SA 5006

Email: health.wchnallergyresearch@sa.gov.au

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

Perth Children's Hospital

Nedlands, WA 6009

Email: foodallergyresearch@health.wa.gov.au

New South Wales

Currently Recruiting

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

Email: SCHN-SCHClinicalTrials@health.nsw.gov.au

United States

Arkansas

Not yet recruiting

Arkansas Children's Research Institute
Little Rock, Arkansas,
 72202

Maryland

Not yet recruiting

Johns Hopkins Hospital

Baltimore, Maryland, 21205

California

Not yet recruiting


Peninsula Research Associates

Rolling Hills Estates, California, 90274

Massachusetts

Not yet recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Georgia

Not yet recruiting

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329

North Carolina

Not yet recruiting

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

For further information, click here

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