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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

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 (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)
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author
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publishing date
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 (&gt;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}},
}