Intercell starts European Pivotal Phase III clinical trial for the patch-based Travelers' Diarrhea Vaccine

16-Oct-2009 - Austria

Intercell AG announced that its travelers' diarrhea (TD) Vaccine Patch has entered clinical Phase III development. A pivotal efficacy field study started with the first subjects vaccinated in the United Kingdom. The randomized and placebo-controlled study with travelers from Europe to Mexico and Guatemala will evaluate the efficacy of the TD Vaccine Patch to actively immunize against moderate to severe ETEC (enterotoxigenic E. coli) disease in a field setting. The trial will be conducted in the European Union, mainly the UK and Germany, and will include 1,800 subjects travelling to Mexico and Guatemala.

“The start of our pivotal efficacy Phase III trial is a key achievement in the clinical development of the worldwide first vaccine delivered with a patch,” stated Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA. “ETEC is the main cause for diarrhea in travelers. Therefore, a patch-based TD vaccine has the potential to significantly reduce the disease burden, severity and incidence of travelers’ diarrhea episodes.”

The TD vaccine system consists of a self-adhesive patch containing the vaccine antigen, the LT - heat-labile toxin - from E. coli, and a single-use device used to prepare the skin at the site of patch administration, the Skin Preparation System (SPS). Intercell combines the classical toxin approach to vaccination with its patch-based, needle-free delivery system. The SPS partially disrupts the stratum corneum of the skin. The dry patch contains the antigen in a stabilizing excipient formulation and delivers the antigen to the skin. Activated Langerhans cells take up the antigen and deliver it to the draining lymph nodes.

In an earlier randomized, double blind placebo-controlled Phase II field trial the vaccine showed excellent immunogenicity and reduced the risk of clinically significant diarrheal episodes in travelers to Mexico and Guatemala. The started Phase III trial with 1,800 subjects will evaluate the efficacy of the TD Vaccine for prevention of moderate to severe ETEC disease in the same field setting.

https://www.bionity.com/en/news/107995/intercell-starts-european-pivotal-phase-iii-clinical-trial-for-the-patch-based-travelers-diarrhea-vaccine.html