drugset / Trial / NCT03066986

Study of Sting Challenge and Serological Responses to Jack Jumper Venom Immunotherapy With Inulin as Adjuvant (Jumpvax)

NCT03066986 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to assess the potential use of delta-inulin as an adjuvant to facilitate the desired immune response to Jack Jumper Ant (JJA) venom with a lower dose of venom, thus reducing adverse reactions, venom requirements and costs of treatment. Specifically we aim to compare outcomes of in-hospital JJA sting challenges and JJA venom specific IgE, and IgG4 responses to semi-rush JJA VIT at maintenance doses of 25 and 50 mcg of JJA venom, with and without delta-inulin adjuvant.

Timeline

Start
2016-10
Primary completion
2021-12
Completion
2021-12

Outcome

Missed primary endpoint

paper There was no difference between groups for sting challenge outcome (p = 0.98) PMID 41748259 ↗

paper Challenge outcomes were similar for all groups, with no significant difference found between 25 and 50 mcg maintenance dose or between treatment with and without Advax. PMID 41748259 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Delta Inulin Other / unclassified 5 mg —