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Phase I for Influenza vaccine adjuvanted with Intercell’s IC31(TM) started |
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19 Jun 2007 |
Phase I clinical trial for a superior seasonal Influenza vaccine formulated with IC31™ started
VIENNA, Austria | June 18, 2007 | Vaccine company Intercell AG (VSE: ICLL) announced today the start of Phase I clinical trials for a seasonal Flu vaccine which is formulated with Intercell’s proprietary adjuvant IC31™.
The currently available, mostly non-adjuvanted vaccine products have a suboptimal efficacy profile, especially in the population groups with the highest disease burden (elderly and infants). Furthermore, these vaccines only offer limited cross-protection against other influenza strains, with no or low T-cell responses. Due to these limitations, novel vaccines with improved efficacy and T-cell immunity are needed.
The IC31™ adjuvanted Flu vaccine is expected to overcome these shortcomings, which would be also desired for pre-pandemic vaccines.
Preclinical animal models already showed that the vaccine could increase Haemaglutinin titers and specific T-cell responses significantly. Furthermore, the presence of IC31™ induces very long-lasting and high levels of Flu-specific T-cells as well as IgG2a, both markers for an immune response known to improve and broaden protection from Influenza infections.
In this Phase I trial, a single dose of the IC31™ adjuvanted Flu vaccine will be applied to healthy volunteers. Three different dose groups (no IC31™ – low IC31™ – high IC31™) will be tested. The primary endpoints of the study comprise the safety and immunogenicity of the vaccine at day 21.
“Both the encouraging preclinical data and the outstanding immunogenicity profile in humans have opened a new and attractive market for our adjuvant IC31™ in the development of vaccines. With this study, an important development step for the next generation Influenza vaccines has begun”, stated Gerd Zettlmeissl, CEO of Intercell.
About IC31™
Adjuvants enhance the effectiveness of vaccines. Existing adjuvants on the market induce antibodies but no or little T-cell immunity.
IC31™ is an adjuvant inducing both T-cell and B-cell responses with a unique synthetic formulation, which combines the immunostimulating properties of an anti-microbial peptide, KLK, and an immunostimulatory oligodeoxynucleotide, ODN1a. The two-component solution can simply be mixed with antigens: no conjugation is required.
SOURCE: Intercell |
