MedTrace Logo

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

NCT03066986 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-08-11

No results posted yet for this study

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.

Conditions

  • Ant Sting
  • Immunotherapy

Interventions

DRUG

Delta-inulin

Addition of adjuvant, delta-inulin to JJA VIT regime, to determine if this will allow lower doses and shorter regimes to promote protective responses, reducing costs and morbidity of JJA VIT.

BIOLOGICAL

Dose finding comparison

Define minimum effective maintenance dose (50mcg vs 25mcg). In "real world" sting challenges after 12 months of JJA VIT objective systemic reaction rates after 50 and 100 mcg maintenance doses respectively 14/130 and 12/126 subjects vs reaction rates to stings in similar subjects without JJA VIT 70-76%. Venom delivery in sting likely \<20mcg. Therefore minimum effective maintenance dose not yet defined.

Sponsors & Collaborators

  • Vaxine Pty Ltd

    collaborator INDUSTRY

  • Central Adelaide Local Health Network Incorporated

    lead OTHER_GOV

Principal Investigators

  • Pravin Hissaria, FRACP FRCPA · Royal Adelaide Hospital and SA Pathology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03066986 on ClinicalTrials.gov