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Trial record 2 of 7 for:    Recruiting, Not yet recruiting, Available Studies | "Bites and Stings"

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

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ClinicalTrials.gov Identifier: NCT03066986
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
Vaxine Pty Ltd
Information provided by (Responsible Party):
Professor Robert Heddle, Central Adelaide Local Health Network Incorporated

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.

Condition or disease Intervention/treatment Phase
Ant Sting Immunotherapy Drug: Delta-inulin Biological: Dose finding comparison Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

Arm Intervention/treatment
Experimental: 25mcg JJA venom
Subjects will receive semi-rush JJA VIT (without delta-inulin) aiming to achieve a maintenance dose of JJA venom of 25mcg (dose finding comparison).
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.

Experimental: 25mcg JJA venom + 5mg delta-inulin
Subjects 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).
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.
Other Name: Advax

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.

Active Comparator: 50mcg JJA venom
Subjects 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.
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.

Experimental: 50mcg JJA venom + 5mg delta-inulin
Subjects 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).
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.
Other Name: Advax

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.




Primary Outcome Measures :
  1. Response to in-hospital JJA sting following 12 months of maintenance treatment [ Time Frame: 15 months ]
    Number of subjects in each group experiencing systemic allergic reaction to in-hospital JJA sting after 12 months of maintenance treatment.

  2. Specific IgG4 responses to JJA venom during treatment [ Time Frame: 18 months ]
    Specific IgG4 responses (mcgA/L) to JJA venom immunotherapy by group

  3. Specific IgE responses to JJA venom during treatment [ Time Frame: 18 months ]
    Specific IgE responses (kU/L) to JJA venom immunotherapy by group


Secondary Outcome Measures :
  1. Changes in VST to JJA venom during treatment [ Time Frame: 15 months ]
    Venom skin test responses (concentration of venom which results in a positive intradermal test - mcg/ml) to JJA venom immunotherapy by group

  2. Adverse reactions to JJA venom immunotherapy [ Time Frame: 18 months ]
    Number of events per group and number of subjects per group experiencing clinical adverse reactions attributable to JJA VIT

  3. Incidental reactions to field stings during JJA venom immunotherapy [ Time Frame: 18 months ]
    Number of events per group and number of subjects per group experiencing systemic allergic reactions to incidental JJA stings



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066986


Contacts
Contact: Robert (Bob) J Heddle, FRACP PhD +61401672081 Bob.Heddle@sa.gov.au
Contact: Pravin Hissaria, FRACP FRCPA +61432 003 558 Pravin.Hissaria@sa.gov.au

Locations
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Robert (Bob) J Heddle, FRACP PhD    +61401672081    Bob.Heddle@sa.gov.au   
Contact: Pravin Hissaria, FRACP FRCPA    +61432003558    Pravin.Hissaria@sa.gov.au   
Sponsors and Collaborators
Central Adelaide Local Health Network Incorporated
Vaxine Pty Ltd
Investigators
Principal Investigator: Robert (Bob) J Heddle, FRACP PhD Royal Adelaide Hospital and SA Pathology

Responsible Party: Professor Robert Heddle, Professor Robert Heddle, Head of Clinical Immunology Unit, Royal Adelaide Hospital; Chief Pathologist, SA Pathology (Frome Rd campus), Central Adelaide Local Health Network Incorporated
ClinicalTrials.gov Identifier: NCT03066986     History of Changes
Other Study ID Numbers: CALHN Ref No. R20151007
CT-2015-CTN-03308-1 v2 ( Registry Identifier: Therapeutics Good Administration )
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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-identidied 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 investigator R Heddle.

Keywords provided by Professor Robert Heddle, Central Adelaide Local Health Network Incorporated:
Venom anaphylaxis
Myrmecia piluosa
Immunological adjuvant
Immunotherapy
Jack jumper ant

Additional relevant MeSH terms:
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries