None listed
Conditions
Brief summary
The objectives of this study are to improve the delivery of venom immunotherapy (VIT) by assessing the efficacy and safety of different approaches to venom immunotherapy, namely ultra-rush (ultra-rapid initiation over 2 days) versus semi-rush (initiation over 10 weeks) and half-dose (50 microgram) versus standard dose (100 microgram) maintenance treatment. Specific hypotheses are that: (i) ultra-rush initiation will be equivalent to outpatient semi-rush initiation in terms of allergic reaction rates to immunotherapy; (ii) A maintenance dose of 50 mcg will be as efficacious as a 100 mcg maintenance dose, and; (iii) VIT with both initiation methods and maintenance doses will have a sustained positive impact (reduced reaction risk) after cessation of VIT. The study will have important implications. If the different approaches are equivalent, we will be able to significantly reduce the amount of venom extract used and thus increase the number of patients that we can treat, given that our venom supplies are expensive and limited. Because it will be impossible to conceal treatment allocations, the different initiation methods will be unblinded. Maintenance doses will be single blinded (known to the treating doctor but not the patient) because of the significant day-to-day dose adjustments required during immunotherapy would make double-blinding difficult and potentially dangerous. The main outcome measures will be (1) the occurence of systemic allergic reactions to immunotherapy (safety of treatment) and (2) systemic allergic reactions to deliberate sting challenges and accidental stings (effectiveness of treatment)
Interventions
Venom immunotherapy by subcutaneous injection; randomised 2 x 2 factorial design; ultra-rush (treatment initiation over 2 days) versus semi-rush (treatment initiation over 10 weeks), and 50 mcg versus 100 mcg maintenance dosing every three months for 3-5 years. A patient's choice arm is also available for part of the study where the patient may select either or both of initiation method and maintenance dose.
Sponsors
Department of Health and Human Services, Tasmanian Government
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Adults and children with a history of one or more systemic allergic reactions to a known or suspected JJA sting.
Exclusion criteria
Negative intradermal skin and serum (RAST) tests for venom-specific IgE; pregnancy at time of treatment initiation; psychiatric illness rendering the patient unable to understand the study; severe cardiac or respiratory disease such that there is a high risk of decompensation to the mild-moderate allergic reactions that commonly occur with immunotherapy.
Outcome results
None listed