INTERCELL, SSI REPORT POSITIVE DATA ON TB VACCINE

Intercell and Statens Serum Institut (SSI) have announced that their collaborative novel tuberculosis (TB) vaccine has been shown to be safe and very immunogenic in healthy individuals in a Phase I clinical trial.

Based on these results, the partners will initiate a clinical trial with latent TB-infected individuals and those who have been vaccinated with Bacille Calmette-Guérin (BCG) later this year.

The new H1 vaccine is a recombinant subunit vaccine based on two important TB antigens resulting from SSI's research pipeline combined with Intercell's proprietary adjuvant IC31. The Phase I clinical trial was supported by the European Union-funded program TB-VAC.

The vaccine "is designed to function in a standalone schedule, as well as in combination with previous exposure to BCG or other closely related mycobacteria," Peter Andersen, director of vaccine R&D at SSI, said. "It seems that our decision to combine our antigen with IC31 has been a sound judgment on the basis of our preclinical data."

IC31 was shown in the trial to stimulate a strong T-cell immune response in humans as already previously seen in a variety of animal models.