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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Adelaide Local Health Network Incorporated
• Collaborator: Vaxine Pty Ltd

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