Study of Sting Challenge and Serological Responses to Jack Jumper Venom Immunotherapy With Inulin as Adjuvant (Jumpvax)
Jumpvax
A Dose Ranging Study of Sting Challenge and Specific lgE, and IgG4 Responses to Jack Jumper Ant (JJA) [Myrmecia Pilosula] Venom Immunotherapy (VIT) With and Without Delta-inulin as an Adjuvant.
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 11, 2020
August 1, 2020
5.2 years
February 20, 2017
August 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Response to in-hospital JJA sting following 12 months of maintenance treatment
Number of subjects in each group experiencing systemic allergic reaction to in-hospital JJA sting after 12 months of maintenance treatment.
15 months
Specific IgG4 responses to JJA venom during treatment
Specific IgG4 responses (mcgA/L) to JJA venom immunotherapy by group
18 months
Specific IgE responses to JJA venom during treatment
Specific IgE responses (kU/L) to JJA venom immunotherapy by group
18 months
Secondary Outcomes (3)
Changes in VST to JJA venom during treatment
15 months
Adverse reactions to JJA venom immunotherapy
18 months
Incidental reactions to field stings during JJA venom immunotherapy
18 months
Study Arms (4)
25mcg JJA venom
EXPERIMENTALSubjects will receive semi-rush JJA VIT (without delta-inulin) aiming to achieve a maintenance dose of JJA venom of 25mcg (dose finding comparison).
25mcg JJA venom + 5mg delta-inulin
EXPERIMENTALSubjects will receive semi-rush JJA VIT with delta-inulin (at a fixed dose of 5 mg with each dose of venom) aiming to achieve a maintenance dose of JJA venom of 25mcg (dose finding comparison, adjuvant comparison).
50mcg JJA venom
ACTIVE COMPARATORSubjects will receive semi-rush JJA VIT (without delta-inulin) aiming to achieve a maintenance dose of JJA venom of 50mcg, ie. the current standard of care.
50mcg JJA venom + 5mg delta-inulin
EXPERIMENTALSubjects will receive semi-rush JJA VIT with delta-inulin (at a fixed dose of 5 mg with each dose of venom) aiming to achieve a maintenance dose of JJA venom of 50mcg (adjuvant comparison).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Previous immediate systemic allergic reaction to definite or possible JJA sting.
- Venom-specific lgE response to JJA venom (by intradermal skin testing or serological analysis).
- Age between 18 and 65 years at the time of starting treatment.
- Gives informed consent, including acknowledgement that any protection from JJA sting anaphylaxis may be short lived and that JJA VIT and in particular, JJA sting challenges have the potential to cause systemic allergic reactions, including anaphylaxis.
You may not qualify if:
- Pregnant (women of child-bearing age will have a urine pregnancy test on first day of treatment) or intended pregnancy during treatment.
- Beta-blocker, ACE-inhibitor or mono-amine oxidase therapy for any reason.
- Unstable heart disease.
- Poorly controlled lung disease; defined as being severe enough to cause breathlessness on mild or moderate exertion, i.e. unable to walk up a modest incline.
- Any other chronic or severe medical condition which puts the patient at increased risk if they participated in this study in the investigators opinion.
- Previous JJA VIT, any ongoing immunotherapy or use of immunosuppressive drugs.
- Raised baseline mast cell tryptase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Adelaide Local Health Network Incorporatedlead
- Vaxine Pty Ltdcollaborator
Study Sites (1)
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Pravin Hissaria, FRACP FRCPA
Royal Adelaide Hospital and SA Pathology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Adriana Le, Clinical Immunologist/Allergist, Royal Adelaide Hospital
Study Record Dates
First Submitted
February 20, 2017
First Posted
March 1, 2017
Study Start
October 1, 2016
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
August 11, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Primary and secondary outcome data to be shared with collaborators until end of study (end 2021)
- Access Criteria
- Data access will be limited to collaborators and data safety monitor
IPD will be shared with collaborating institutions/organisations, specifically Royal Hobart Hospital JJA Program and Vaxine Pty Ltd, Flinders Medical Centre. We are prepared to share de-identified data with other researchers. We do not expect any substantive results to be available until February 2018. Enquries for obtaining data should be directed to the primary investigators P Hissaria or TA Le.