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Intercell completes Phase I clinical trial for an improved seasonal Influenza vaccine formulated with IC31
Intercell's strategic Flu partner Novartis to include IC31® in further clinical trials
29 Feb 2008 -
Intercell AG announced the completion of Phase I clinical trials of the companys adjuvant IC31® in combination with the seasonal, trivalent influenza vaccine Agrippal® from Novartis.
In this randomized, controlled Phase I trial, 72 individuals received one shot of either Agrippal®, or Agrippal® combined with one of two different concentrations of IC31®. All study subjects were healthy, adult volunteers, with an average age of approximately 31 years. The majority of participants had preexisting immune responses against influenza strains prior to the trial. Subjects were followed for general safety and local tolerability. Vaccine specific immune responses were analyzed 10 and 21 days after the vaccination. The study was conducted at Vienna Medical University, Department of Clinical Pharmacology. The IC31® adjuvanted vaccine showed even in the highest IC31® dose group an excellent safety and tolerability profile, which was comparable to the nonadjuvanted standard vaccine.
Furthermore in all study groups vaccination with the test vaccine led to the induction of virus specific Tcells and protective levels of antibody responses against the three included influenza strains.
We are excited about the excellent safety and tolerability profile of our IC31® in combination with seasonal influenza antigens in humans, states Gerd Zettlmeissl, Chief Executive Officer of Intercell. This result in combination with the outstanding immunogenicity data in immunocompromised animals has paved the way towards the development of improved Flu vaccines.
IC31® has potential as adjuvant for improved influenza vaccines. Novartis will include IC31® in its further clinical development program.
As part of the agreement between Novartis and Intercell, signed in July 2007, Novartis has an exclusive license for development of Intercell's IC31® adjuvant in novel influenza vaccines with milestones for Intercell of up to approximately EUR 100 m during the development period and doubledigit royalty rates tied to sales performance.
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