Crucell malaria vaccine starts trials in Africa
pharmafile | May 11, 2010 | News story | Research and Development | Crucell, malaria
Dutch biopharma firm Crucell has started a phase I trial of its AdVac-based malaria vaccine in Burkina Faso, West Africa.
It’s the first study to evaluate the vaccine candidate in a population living in a malaria endemic area, and follows a recent phase I study conducted in the US that showed the candidate had an acceptable safety and immunogenicity profile.
Crucell is developing its vaccine 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 of the AdVac-based malaria vaccine vector Ad35-CS is funded by NIAID/NIH and will be conducted by Burkinabè researchers at the CNRFP.
“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.
“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 will be a randomised, controlled, double-blinded, dosage-escalation clinical trial evaluating the immunogenicity and safety of Ad35-CS in malaria semi-immune, healthy adult volunteers living in Burkina Faso.
Crucell’s AdVac technology works by supporting the insertion of genetic material from the disease-causing virus or parasite into a vehicle called a vector, which then delivers it directly to the immune system. In the case of malaria, this parasite is the circumsporozoite stage of the P. falciparum.
In April, Crucell entered an agreement with GlaxoSmithKline to combine its AdVac vector technology in conjunction with GSK’s own malarial vaccine RTS,S/AS that is currently in phase III trials.
The companies are now looking for third party funding to advance the Ad35-CS and RTS,S/AS phase I/IIa clinical trial in the US and will partner with private or public bodies to develop a second generation malaria vaccine candidate.
Ben Adams
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