SCIT-treatment With a Chemically Modified, Aluminum Hydroxide Adsorbed Peanut Extract (HAL-MPE1) Was Generally Safe And Well Tolerated And Showed Immunological Changes In Peanut Allergic Patients
(2017) 2017th AAAAI Annual Meeting- 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... (More) - 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. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/6170569c-9c94-469e-88cd-a28dfec3dcbc
- author
- Bindslev-Jensen, Carsten ; de Kam, Pieter-Jan ; van Twuijver, Esther ; Boot, Diderik ; El Galta, Rachid ; Pahlow Mose, Anja LU ; Kring Tannert, Line and Opstelten, Dirk-Jan
- publishing date
- 2017-02
- type
- Contribution to conference
- publication status
- published
- subject
- pages
- 1 pages
- conference name
- 2017th AAAAI Annual Meeting
- conference location
- Atlanta, United States
- conference dates
- 2017-03-03 - 2017-03-06
- DOI
- 10.1016/j.jaci.2016.12.623
- language
- English
- LU publication?
- no
- id
- 6170569c-9c94-469e-88cd-a28dfec3dcbc
- date added to LUP
- 2023-09-28 08:21:09
- date last changed
- 2023-09-28 09:40:20
@misc{6170569c-9c94-469e-88cd-a28dfec3dcbc, abstract = {{Rationale<br/>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).<br/><br/>Methods<br/>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.<br/><br/>Results<br/>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.<br/><br/>Conclusions<br/>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.}}, author = {{Bindslev-Jensen, Carsten and de Kam, Pieter-Jan and van Twuijver, Esther and Boot, Diderik and El Galta, Rachid and Pahlow Mose, Anja and Kring Tannert, Line and Opstelten, Dirk-Jan}}, language = {{eng}}, title = {{SCIT-treatment With a Chemically Modified, Aluminum Hydroxide Adsorbed Peanut Extract (HAL-MPE1) Was Generally Safe And Well Tolerated And Showed Immunological Changes In Peanut Allergic Patients}}, url = {{http://dx.doi.org/10.1016/j.jaci.2016.12.623}}, doi = {{10.1016/j.jaci.2016.12.623}}, year = {{2017}}, }