PMAL03 |
Phase Ib trial on a potential malaria vaccine
Pevion Biotech and the Molecular Immunology unit of the Swiss TPH have jointly developed a virosome-based malaria vaccine candidate comprising a reconstituted empty influenza virus envelope presenting Plasmodium falciparum derived synthetic peptides on its outer surface.
Facing the demanding task of developing a malaria vaccine and encouraged by promising data from pre-clinical profiling, the PMU coordinated a Phase Ia safety trial at the University Hospital in Basel in 2004. This trial aimed at evaluating the malaria vaccine candidate to produce an appropriate immune response and to determine its safety and tolerability in healthy adult volunteers without pre-exposure to malaria.
Promising results led to a second clinical trial in the main target population: children living in African countries where the disease is highly prevalent. This Phase Ib trial deploys a lyophilised form of the malaria vaccine candidate. Coordinated by the PMU, the trial was started in January 2008 at the Ifakara Health Institute, Bagamoyo Branch, Tanzania. Ten adults and 40 children were enrolled in the joint "PMAL03" project. The trial aims to better understand the humoral and cellular immune response as well as to investigate the vaccine's safety within the malaria-exposed target population.
