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Clinical Trials of PVX108 for Peanut Allergy

Examination of a child
Phase 1 Studies: AVX-001 and AVX-001-EXT (complete)

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AVX-001 was 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 blood 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 were collected for biomarker and immunological 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. Results from these studies have been published in the journal Allergy.

Phase 2 Studies: AVX-201 (currently recruiting)

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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. The AVX-201 trial is being run under an IND and is currently recruiting at clinics in Australia and the United States.

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

Email: health.wchnallergyresearch@sa.gov.au

Victoria

Active, Not 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

Email: foodallergyresearch@health.wa.gov.au

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
 

Currently Recruiting

Sydney Children's Hospital

Randwick, NSW 2031

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

United States

Arkansas

Currently Recruiting

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

Email: NorrisKD@archildrens.org

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California

Currently Recruiting


Peninsula Research Associates

Rolling Hills Estates, California, 90274

Email: dominic.venardi@peninsularesearch.com

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Georgia

Currently Recruiting

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Children's Healthcare of Atlanta

Atlanta, Georgia, 30329

Email: jessica.stafford@choa.org

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Maryland

Currently Recruiting

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Johns Hopkins Hospital

Baltimore, Maryland, 21205

Email: mhairst4@jh.edu

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Massachusetts

Currently Recruiting

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Massachusetts General Hospital

Boston, Massachusetts, 02114

Email: takhtar@mgh.harvard.edu

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North Carolina

Currently Recruiting

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Email: foodallergy@unc.edu

For further information, click here

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