Pevion Biotech reported that it has met the clinical endpoints of the phase I trial for two components of its PeviPROTM-based synthetic malaria vaccine PEV3A. The trial, started in November 2003, was designed to evaluate safety, tolerability and immunogenicity of the vaccine candidate in healthy volunteers.

In close co-operation with the Swiss Tropical Institute, the Swiss Innovation Promotion Agency (CTI) and the University hospital Basel, two synthetic peptide vaccine components were administered alone and in combination to 46 healthy participants as a randomised, placebo-controlled blind study.

The clinical trial compared different doses in five study groups with eight volunteers in each group. Six volunteers received virosomes alone. After two vaccinations the clinical data show that the peptide vaccine components are well tolerated, safe and highly immunogenic, which confirms the preclinical data and marks the achievement of all goals set for this trial.

Rinaldo Zurbriggen, CSO of Pevion Biotech, states, "I am highly satisfied with the immunogenicity of the first malaria vaccine candidate. The very positive results also represent the first proof of concept of PeviPROTM, virosomal formulated peptide vaccines, in humans. It's a great achievement of our team to bring a vaccine candidate successfully trough clinical testing within two years after founding of the company."

The study is to be continued with a third vaccination to evaluate further immunological aspects of the vaccination. The data obtained allow rational selection of the optimal dose and formulation for the planned phase II study. In parallel Pevion Biotech will proceed in the preclinical development of further malaria vaccine components, the release from the company added.

Pevion Biotech is specialised in the development of vaccines, based on the proprietary virosome technology platforms, from the research phase to clinical trials.