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Immunotherapy
PVX-108 for Peanut Allergy
Phase 2
Waitlist Available
Led By Brian Vickery, MD
Research Sponsored by Aravax Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 74 weeks
Summary
This trial tests a new treatment to reduce allergic reactions to peanuts in kids and teens with peanut allergies.
Who is the study for?
This trial is for children and adolescents with a doctor-confirmed peanut allergy, demonstrated by specific blood tests and skin prick tests. They must have had a reaction to a small amount of peanut protein in a controlled test. Kids with moderate or severe asthma are excluded, as well as those who've tried desensitizing treatments before.
What is being tested?
The study is testing PVX108 immunotherapy against a placebo to see if it's safe and can reduce allergic reactions to peanuts. Participants will be randomly assigned to receive either the real treatment or the placebo.
What are the potential side effects?
While not specified here, potential side effects may include typical allergic responses such as itching, swelling at the injection site, respiratory issues, or more serious reactions like anaphylaxis due to exposure to allergen components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 74 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 74 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Therapeutic procedure
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: PVX108 50 nmol in childrenExperimental Treatment1 Intervention
Twelve 4-weekly ID doses of PVX108 at 50 nmol in children (Cohort 2)
Group II: PVX108 50 nmol in adolescentsExperimental Treatment1 Intervention
Twelve 4-weekly intradermal (ID) doses of PVX108 at 50 nmol in adolescents (Cohort 1)
Group III: PVX108 5 nmol in childrenExperimental Treatment1 Intervention
Twelve 4-weekly ID doses of PVX108 at 5 nmol in children (Cohort 2)
Group IV: Placebo in adolescentsPlacebo Group1 Intervention
Twelve 4-weekly ID doses of placebo matching PVX108 in adolescents (Cohort 1)
Group V: Placebo in childrenPlacebo Group1 Intervention
Twelve 4-weekly ID doses of placebo matching PVX-108 in children (Cohort 2)
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Who is running the clinical trial?
Aravax Pty LtdLead Sponsor
Brian Vickery, MDPrincipal InvestigatorEmory University