Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy

Summary

The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by: * skin prick testing * grass pollen inhalation challenge * antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.

Timeline

Start

2011-10

Primary completion

2012-03

Completion

2012-10

Outcome

Met primary endpoint

paper TNSS significantly decreased with mean changes of -1.41 (BM32/20μg) (P=0.03) and -1.34 (BM32/40μg) (P=0.003) PMID 27650868 ↗

Publications

• Zieglmayer P, Focke-Tejkl M, Schmutz R, Lemell P, Zieglmayer R, Weber M, Kiss R, Blatt K, Valent P, Stolz F, Huber H, Neubauer A, Knoll A, Horak F, Henning R, Valenta R. Mechanisms, safety and efficacy of a B cell epitope-based vaccine for immunotherapy of grass pollen allergy. EBioMedicine. 2016 Sep;11:43-57. doi: 10.1016/j.ebiom.2016.08.022. Epub 2016 Aug 20.

Drugs

Indications