Abstract
Rationale
There is no effective disease modifying treatment for peanut allergy available. A Phase I safety and tolerability study was performed with a chemically modified, Al(OH)3 adsorbed peanut extract (HAL-MPE1) for subcutaneous immunotherapy (SCIT).
Methods
In a randomized, double-blind, placebo controlled, single-centre, Phase I study, 17 Caucasian subjects with peanut allergy were randomized to receive 15-20 weekly incremental doses of either HAL-MPE1 (11 subjects) or placebo (6 subjects). The primary safety and tolerability endpoints were early (≤4 hrs) and late (>4 hrs) local and systemic reactions. In addition, changes in peanut specific immunoglobulin levels and basophil histamine release were assessed.
Results
Early and late local reactions were more frequently observed after HAL-MPE1 compared to placebo, were generally of mild intensity and mainly consisted of redness and no wheal sizes exceeding 5 cm were recorded. Early systemic reactions were only observed in the active treatment group. No late systemic reactions exceeding Grade I were observed after HAL-MPE1. Increased IgG and IgG4 levels specific for peanut extract, Ara h 1, Ara h 2, Ara h 3, Ara h 6 were noted following active treatment as compared to placebo. A trend towards reduced basophil histamine release after HAL-MPE1 was observed.
Conclusions
The observed incidence rates, time course and intensity of the early and late local and systemic reactions support that treatment with HAL-MPE1 was generally safe and well tolerated. Furthermore, HAL-MPE1 is capable of inducing immunological changes following 4-5 months of weekly dose escalations.
There is no effective disease modifying treatment for peanut allergy available. A Phase I safety and tolerability study was performed with a chemically modified, Al(OH)3 adsorbed peanut extract (HAL-MPE1) for subcutaneous immunotherapy (SCIT).
Methods
In a randomized, double-blind, placebo controlled, single-centre, Phase I study, 17 Caucasian subjects with peanut allergy were randomized to receive 15-20 weekly incremental doses of either HAL-MPE1 (11 subjects) or placebo (6 subjects). The primary safety and tolerability endpoints were early (≤4 hrs) and late (>4 hrs) local and systemic reactions. In addition, changes in peanut specific immunoglobulin levels and basophil histamine release were assessed.
Results
Early and late local reactions were more frequently observed after HAL-MPE1 compared to placebo, were generally of mild intensity and mainly consisted of redness and no wheal sizes exceeding 5 cm were recorded. Early systemic reactions were only observed in the active treatment group. No late systemic reactions exceeding Grade I were observed after HAL-MPE1. Increased IgG and IgG4 levels specific for peanut extract, Ara h 1, Ara h 2, Ara h 3, Ara h 6 were noted following active treatment as compared to placebo. A trend towards reduced basophil histamine release after HAL-MPE1 was observed.
Conclusions
The observed incidence rates, time course and intensity of the early and late local and systemic reactions support that treatment with HAL-MPE1 was generally safe and well tolerated. Furthermore, HAL-MPE1 is capable of inducing immunological changes following 4-5 months of weekly dose escalations.
| Original language | English |
|---|---|
| Number of pages | 1 |
| DOIs | |
| Publication status | Published - 2017 Feb |
| Externally published | Yes |
| Event | 2017th AAAAI Annual Meeting - Atlanta, United States Duration: 2017 Mar 3 → 2017 Mar 6 |
Conference
| Conference | 2017th AAAAI Annual Meeting |
|---|---|
| Country/Territory | United States |
| City | Atlanta |
| Period | 2017/03/03 → 2017/03/06 |
Subject classification (UKÄ)
- Dermatology and Venereal Diseases