Currently, there is no effective causal treatment for peanut allergy. A chemically modified, aluminium hydroxide adsorbed peanut extract (HAL-MPE1) for subcutaneous administration has been developed. Results from in vitro and in vivo preclinical studies demonstrate the immunotherapeutic potential of HAL-MPE1. Therefore, a phase I, single-centre clinical trial has been designed to assess the safety and tolerability of HAL-MPE1 in peanut allergic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Carsten Bindslev-Jensen
Odense, Denmark
Safety of a SCIT-treatment with HAL-MPE1 in patients with peanut allergy.
* Occurrence of early and late local reactions * Occurrence of early and late systemic reactions * Occurrence of adverse events (clinically relevant abnormalities of the physical examination will be documented as adverse events) * Changes in laboratory values, vital signs, ECG and lung function.
Time frame: up to 20 weeks
Change in serum levels of allergen specific immunoglobulins
Time frame: before and after 15-20 weeks of treatment
Change in basophil histamine release test
Time frame: before and after 15-20 weeks treatment
Change in titrated skin prick test
Time frame: before and after 15-20 weeks of treatment
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