Intercell announces first data from its Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections
- Category: Vaccines
- Published on Monday, 24 October 2011 12:51
- Hits: 2473
» Intercell is progressing its vaccine candidate against Clostridium difficile, the major cause of nosocomial diarrhea, into the target population of elderly subjects based on initial data from its Phase I study
» Data show good safety and immunogenicity of the vaccine candidate and indicate functionality of the induced antibodies
» Second part of the study in the target population of elderly subjects will be initiated
VIENNA, Austria I October 24, 2011 I Intercell AG (VSE: ICLL) today announced first data from a Phase I clinical trial with the company's vaccine candidate IC84 to prevent disease caused by the bacterium Clostridium difficile (C. difficile). The pathogen is one of the main causes of nosocomial diarrhea.
Intercell's vaccine candidate is a recombinant protein vaccine 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.
This Phase I trial is a first-in-man study to obtain safety and immunogenicity data. The first part of the study is in a population of healthy adults up to 65 years. The second part is in healthy elderly subjects above 65 years of age as this age group is considered to represent the main target population for a C. difficile vaccine.
The first part of the study has enrolled 60 healthy adults (18-65 years). Three different alum-adjuvanted vaccine candidate concentrations were tested in a 3 times–vaccination schedule; two of the three vaccine concentrations were additionally tested without adjuvant.
An independent Data Safety Monitoring Board (DSMB) reviewed safety as primary objective of the study and did not identify any safety concern in any of the IC84 treatment arms.
IC84 induced antibodies reacted with both native toxins A and B of C. difficile. A dose response to the vaccine candidate could be observed; the non-adjuvanted candidates were at least as immunogenic as the adjuvanted for both toxins, respectively.
Functionality of IC84-induced antibodies could be shown in toxin-neutralizing assays.
Based on the data form the first part of the study, the two higher doses will be carried forward to the second part of the study for dose-confirmation in elderly. Also, the necessity of the adjuvant will need to be confirmed in the elderly, who might respond differently to vaccination than the younger subjects due to immunosenescence. Modification of the vaccination schedule will be implemented to potentially further optimize the immune response in elderly.
About Clostridium difficile infection
C. difficile is an anaerobic spore-forming bacterium that causes diarrhea and more serious intestinal conditions such as colitis. C. difficile is shed in faeces and any surface, device, or material that becomes contaminated with faeces may serve as a reservoir for the C. difficile spores. When the natural microbial flora of the gut is disturbed (e.g. as a result of antibiotic treatment) and a patient gets in contact with C. difficile spores - this can result in a broad range of gastrointestinal symptoms. The symptoms may include diarrhea, cramping, dehydration, fever, nausea and vomiting. In advanced stages it can cause bloody diarrhea and severe inflammation of the gut. C. difficile spores are transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item.
C. difficile rarely causes infections in healthy persons but is a significant threat for patients with gastrointestinal surgery, or for subjects in healthcare settings or with immunocompromising conditions.
Currently, no vaccine against C. difficile exists, and antibiotic treatment of the established disease has significant limitations. The incidence of nosocomial infections is steadily increasing due to the growing number of medical interventions and antibiotic resistance. Intercell aims at developing a vaccine for the prevention of recurring C. difficile Diarrhea, for hospital prophylaxis, and eventually for community-wide prophylaxis on an age- and risk-based vaccination strategy.
About Intercell AG
Intercell AG is a vaccine-biotechnology company with the clear vision to develop and commercialize novel immunomodulatory biologicals to prevent disease and reduce suffering across the world.
Intercell's vaccine to prevent Japanese Encephalitis (JE) is the Company's first product on the market.
The Company's technology base includes novel platforms, such as the patch-based delivery system and the proprietary human monoclonal antibody discovery system eMabs®, in addition to well-established technologies upon which Intercell has entered into strategic partnerships with a number of leading pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., and sanofi-aventis.
The Company's pipeline of investigational products includes a development program for the pediatric use of Intercell's JE-Vaccine IXIARO® in endemic markets (in collaboration with Biological E.) and non-endemic markets. Furthermore, the portfolio comprises different product candidates in clinical trials: a Pseudomonas aeruginosa vaccine candidate (Phase II/III) partnered with Novartis, a vaccine to prevent Pandemic Influenza by combining the Company's Vaccine Enhancement Patch with an injected vaccine (Phase I), a combination treatment approach for Hepatitis C (Phase II) partnered with Romark, a vaccine candidate against infections with C. difficile (Phase I) as well as partnered vaccine programs using the Company's IC31® adjuvant, e.g. in a Tuberculosis vaccine candidate.
Intercell is listed on the Vienna Stock Exchange under the symbol "ICLL" (U.S. level one ADR symbol "INRLY").
For more information, please visit: www.intercell.com
Campus Vienna Biocenter 3, A-1030 Vienna