EANS-News: Intercell AG Intercell starts the second part of a Phase I clinical
trial with vaccine candidate to prevent Clostridium difficile infections
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Research & Development
Wien (euro adhoc) - -
» Trial in vaccine target group of elderly subjects (elderly >65 years)
initiated
» First data from Phase I clinical trial showed good safety and immunogenicity
of the vaccine candidate against Clostridium difficile, the major cause of
nosocomial diarrhea, in healthy young adults
» Study aims to obtain safety and immunogenicity data in elderly subjects with
results expected in Q2 2013
Vienna (Austria), March 1, 2012 - Intercell AG (VSE: ICLL) today announced the
start of the second half of a Phase I clinical trial with the company's vaccine
candidate IC84 to prevent disease caused by the bacterium Clostridium difficile
(C. difficile).
First data from the Phase I study (Phase Ia) in a population of healthy adults
aged 18-65 years showed good safety and immunogenicity of the vaccine candidate,
and indicated functionality of induced antibodies in this study population. This
supported the decision to carry forward the vaccine candidate for safety and
dose-confirmation in the elderly.
The second part of the Phase I study (Phase Ib) will enroll 80 healthy elderly
subjects above 65 years of age, as this age group represents the main target
population for a C. difficile vaccine. Two vaccine concentrations will be tested
with and without alum to confirm the vaccine dose and necessity of the adjuvant
in the elderly. Compared to the Phase Ia part of the study in healthy young
adults, the vaccination schedule has been modified to potentially optimize the
immune response in elderly subjects who might respond differently to the
vaccination due to their immunosenescence.
Intercell's vaccine candidate is a recombinant fusion protein consisting of two
truncated toxins A and B from C. difficile. The toxins are known to be
disease-causing and anti-toxin immunity can be protective.
The pathogen C. difficile is one of the main causes of nosocomial diarrhea.
Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com
end of announcement euro adhoc
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company: Intercell AG
Campus Vienna Biocenter 3
A-1030 Wien
phone: +43 1 20620-0
FAX: +43 1 20620-800
mail: investors@intercell.com
WWW: www.intercell.com
sector: Biotechnology
ISIN: AT0000612601
indexes: ATX Prime
stockmarkets: official market: Wien
language: English