Sanaria reports positive results from Phase II trial of PfSPZ Vaccine for malaria
US-based biotechnology company Sanaria has reported positive results from a Phase II clinical trial of its PfSPZ Vaccine to fight malaria.
The trial was conducted by a team of clinical investigators at the Naval Medical Research Center and Walter Reed Army Institute of Research and was headed by Captain Judith Epstein and Major Kris Paolino.
It enrolled 69 volunteers aged between 19 and 45, out of whom 45 volunteers were administered three to five rapid 0.5mL injections by direct venous inoculation of the PfSPZ Vaccine.
The PfSPZ Vaccine is composed of live, purified, weakened malaria parasites that cannot cause malaria.
After being treated for three weeks, 89% volunteers received protection against Plasmodium falciparum malaria parasites, which were similar to those in the vaccine transmitted after being exposed to malaria-infected mosquitoes.
Four out of five or 80% of the volunteers were immune to parasites that were different from those in the vaccine and following 24 weeks after the last dosage, 63% of volunteers were protected against parasites similar to those in the vaccine.
Sanaria founder and CEO Stephen Hoffman said: “The findings from this research, particularly the protection achieved with just three doses of vaccine and the protection against parasites significantly different than those administered, lays a solid foundation for the ongoing clinical trial expected to finalise the immunisation regimen required for licensure of Sanaria PfSPZ Vaccine.”
Sanaria is planning to conduct future clinical trials of the PfSPZ Vaccine in Africa, the US, and Europe to obtain license of the product for its usage in mass vaccination programmes in the countries most affected by malaria.
Image: Photomicrograph displaying Plasmodium falciparum parasite. Photo: courtesy ofCenters for Disease Control and Prevention/Dr Mae Melvin/Transwiki approved by: w:en:User:Dmcdevit/Wikipedia.