Pharmaceutical Business review

Crucell, NIH Initiate Malaria Vaccine Phase I Clinical Study

Crucell is developing the malaria vaccine vector in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the 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 randomised, 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.

Crucell said that the study is funded by NIAID/NIH and conducted by Burkinabe researchers at the CNRFP, lead by the director of the CNRFP Sodiomon Sirima.

A Phase I clinical study recently completed in the US demonstrated that the Ad35-CS vector has an acceptable safety and immunogenicity profile in malaria naïve, healthy adult volunteers.

Jerald Sadoff, chief medical officer at Crucell, said: “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.”