Dutch biopharmaceutical company Crucell NV has started phase-I clinical study in Burkina Faso of its AdVac-based malaria vaccine vector. Crucell is developing its malaria vaccine vector in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), the Centre National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso, and the Noguchi Memorial Institute for Medical Research at the University of Ghana.
The study is a randomized, controlled, double-blinded, dosage-escalation clinical trial evaluating the immunogenicity and safety of the recombinant malaria vaccine vector Ad35-CS in malaria semi-immune, healthy adult volunteers living in Burkina Faso. This is the first study evaluating the safety and immunogenicity of this AdVac-based malaria vaccine vector candidate in a population residing in a malaria endemic area.
"We are very pleased that the collaboration with NIH enables us to enter into this new trial," said Dr Jerald Sadoff, Crucell's chief medical officer at Crucell. "Using Crucell's technologies, we are on a joint mission to develop a vaccine against malaria, one of the top three killers in the world, causing close to a million deaths every year, mostly amongst children."
The study is funded by NIAID/NIH and conducted by Burkinabè researchers at the CNRFP, lead by the director of the CNRFP Dr Sodiomon B Sirima. "The innovative approach in designing this malaria vaccine vector gives us confidence that it could open a new, promising era in the quest for an effective malaria vaccine, which would save the lives of millions of our children," said Dr Sirima.
A phase-I clinical study recently completed in the United States demonstrated that the Ad35-CS vector has an acceptable safety and immunogenicity profile in malaria naïve, healthy adult volunteers.
AdVac technology is a vaccine technology developed by Crucell and is considered to play an important role in the fight against emerging and reemerging infectious diseases, and in biodefense.
Crucell's PER.C6 technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines.
Crucell is developing a recombinant malaria vaccine, Ad35-CS, based on the company's AdVac technology and PER.C6 manufacturing platform.