Immunotherapy Clinical Trial
— JumpvaxOfficial 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.
Verified date | August 2020 |
Source | Central Adelaide Local Health Network Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 2021 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Lead Sponsor | Collaborator |
---|---|
Central Adelaide Local Health Network Incorporated | Vaxine Pty Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Specific IgG4 responses to JJA venom during treatment | Specific IgG4 responses (mcgA/L) to JJA venom immunotherapy by group | 18 months | |
Primary | Specific IgE responses to JJA venom during treatment | Specific IgE responses (kU/L) to JJA venom immunotherapy by group | 18 months | |
Secondary | Changes in VST to JJA venom during treatment | Venom skin test responses (concentration of venom which results in a positive intradermal test - mcg/ml) to JJA venom immunotherapy by group | 15 months | |
Secondary | Adverse reactions to JJA venom immunotherapy | Number of events per group and number of subjects per group experiencing clinical adverse reactions attributable to JJA VIT | 18 months | |
Secondary | Incidental reactions to field stings during JJA venom immunotherapy | Number of events per group and number of subjects per group experiencing systemic allergic reactions to incidental JJA stings | 18 months |
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