PfSPZ
PfSPZ
is a Malaria vaccine candidate composed of attenuated sporozoites
Under development by Sanaria Inc., with support of the i-PfSPZ-consortium
PfSPZ
Sanaria PfSPZ Vaccine is a radiation attenuated whole organism vaccine, meaning it is a weakened form of the parasite that causes malaria. It is capable of entering liver cells, but can’t develop further to cause disease. Rather than basing the vaccine on one or a small number of proteins from the pathogen, as most vaccines have done since the advent of gene cloning, Sanaria used the whole pathogen, providing the entire array of proteins. PfSPZ Vaccine elicits an immunological response in the body against the malaria pathogen, without the individual getting sick. This results in robust and durable protection. On the verge of Phase III clinical trials, PfSPZ Vaccine is positioned to be the world’s first malaria vaccine to receive marketing authorization (licensure) by the European Medicines Agency and the US Food and Drug Administration. PfSPZ Vaccine is safe, well tolerated and protective against malaria in multiple clinical trials in Africa, Germany, and the US.
PfSPZ Vaccine has demonstrated 92-100% vaccine efficacy (VE) against homologous (the same strain of parasite as the vaccine itself) controlled human malaria infection (CHMI) at 3-11 weeks after the last vaccine dose in the US, Germany, Tanzania, and Mali. VE against heterologous (a very divergent strain) CHMI, which more closely reproduces the heterogeneous array of parasites transmitted in nature, has been 80% at 3 weeks in the US, 78% through 9.5 weeks in Germany, and 54% at 33 weeks after last immunization in the US.
In 4 different clinical trials in adults in Mali and Burkina Faso living in settings of intense natural seasonal Pf transmission and with previous exposure to malaria, VE during 6 months against naturally transmitted Pf was 47% to 57%. In Burkina Faso, VE was undiminished during a second year of transmission, demonstrating 18 months of sustained protection.
Based on VE and safety results, Sanaria is scaling up manufacturing and has improved its vaccine manufacturing facility to meet Phase III and launch compliance, and will be ready to initiate clinical trials with Phase III compliant vaccine.
Sanaria Inc. is a Biotech company, located in Maryland, USA, developing vaccines against the parasite Plasmodium falciparum (Pf), one of the deadliest form of malaria parasites. The company has been working towards the goal of eliminating malaria in endemic regions since its foundation in 2003. Sanaria is the only vaccine company in the world dedicated solely to the development of malaria vaccines. It is part of several research collaborations in Europe, Asia and the USA.