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Immunotherapy

PVX-108 for Peanut Allergy

Phase 2

Recruiting

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 74 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Placebos

Secondary outcome measures

Change from baseline in peak expiratory flow

Frequency of events of each severity grade during the Week 46 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo

Frequency of events of each severity grade during the Week 71 DBPCFC in children aged 4 to 11 years treated with PVX108 compared to placebo

+14 more

Other outcome measures

Change from baseline in FAIM score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo

Change from baseline in FAQLQ-Parent Form (FAQLP-PF) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in children enrolled in Cohort 2 treated with PVX108 compared to placebo

Change from baseline in FAQLQ-Parent Form Teenager (FAQLQ-PFT) score (Range 1-7, higher score indicates worse outcome) at Week 46 and at Week 71 in adolescents enrolled in Cohort 1 treated with PVX108 compared to placebo

+17 more

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)

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Aravax Pty LtdLead Sponsor

Brian Vickery, MDPrincipal InvestigatorEmory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the recruitment process for this trial include individuals over twenty years of age?

"This research project is currently seeking participants who are between the ages of 4 and 17."

Answered by AI

How many people have enrolled in this medical experiment?

"The study necessitates 90 suitable patients to be recruited across two centres in California and Georgia: Peninsula Research Associates in Rolling Hills Estates, CA and Children's Healthcare of Atlanta."

Answered by AI

Is it possible to participate in this research project?

"This trial is searching for 90 volunteers aged between 4 and 17 years old that have been diagnosed with peanut allergies."

Answered by AI

How many medical facilities are engaged in conducting this trial?

"This clinical study is being conducted at Peninsula Research Associates in Rolling Hills Estates, Children's Healthcare of Atlanta and Johns Hopkins Hospital. Additionally there are 12 other sites where the trial is taking place."

Answered by AI

Has the FDA given clearance to utilize PVX108 50 nmol in teenage patients?

"Our assessment of PVX108 50 nmol's safety in adolescents is a 2, as Phase II trials have provided us with some evidence that the drug is not dangerous but no proof yet of its efficacy."

Answered by AI

Is it feasible to enroll in this clinical experiment at present?

"Affirmative. According to records accessible on clinicaltrials.gov, this medical research trial is currently recruiting participants and was initially posted in February of 2023 with its most current update taking place at the end of October that same year. Ninety patients are necessary for a successful enrolment from 12 distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy

2023. "A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05621317.

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