Intercell starts an additional efficacy trial for its patch-based investigational Travelers’ Diarrhea Vaccine System in Asia

Phase II pilot efficacy trial - placebo controlled field study to evaluate efficacy and enterotoxigenic E. coli (ETEC) incidence of vaccinated European travelers to India

05-Jan-2010 - Austria

Intercell AG announced the start of a Phase II study in India as part of its clinical development program for the investigational Travelers’ Diarrhea (TD) Vaccine system. This placebo controlled field study with vaccinated travelers from the EU to India will test the efficacy of the Intercell TD vaccine. The primary objective of this clinical trial is prevention of all moderate/severe diarrheal cases in which LT, LT/ST or ST toxins (ETEC) are detected. The trial will enroll approximately 800 travelers from the UK and Germany.

“The start of our next important TD trial underlines our dynamic route to licensure and earliest possible commercialization with our marketing partner GSK. Positive results from this study can greatly support our expected product target profile” stated Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA.

The TD vaccine system is a combination of a patch containing the dry‐formulated LT (heatlabile toxin from E. coli, the vaccine antigen) with a skin preparation system (SPS). The skin preparation system (SPS) disrupts the stratum corneum of the skin and prepares the skin for the antigen delivery. The antigen is dissolved from the patch by transepidermal water loss and diffuses into the skin. Activated Langerhans cells take the vaccine antigen to the draining lymph nodes where the immune response is initiated. Currently, this product candidate is undergoing pivotal Phase III testing in about 1,800 European travelers to Latin America. First results are expected end 2010 / early 2011.

https://www.bionity.com/en/news/111347/intercell-starts-an-additional-efficacy-trial-for-its-patch-based-investigational-travelers-diarrhea-vaccine-system-in-asia.html