Intercell completes Phase I influenza vaccine trial

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 pre-existing 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 non-adjuvanted standard vaccine. Furthermore in all study groups vaccination with the test vaccine led to the induction of virus specific T-cells and protective levels of antibody responses against the three included influenza strains. IC31 has potential as adjuvant for improved influenza vaccines. Novartis has reported that it will include IC31 in its further clinical development program.

Gerd Zettlmeissl, CEO of Intercell, said: “This result in combination with the immunogenicity data in immuno-compromised animals has paved the way towards the development of improved flu vaccines.”