Research Project
9478837
ABSTRACT The development of Sanaria?s Plasmodium falciparum (Pf) sporozoite (SPZ)-based vaccines is receiving overwhelming global support after the publication in 2013 in Science of clinical data showing 100% protection against controlled human malaria infection (CHMI) following intravenous administration of 5 doses of Sanaria® PfSPZ Vaccine, composed of purified, aseptic, radiation-attenuated, cryopreserved PfSPZ meeting all regulatory standards. This success led to the formation of the International PfSPZ Consortium, which in collaboration with Sanaria, developed and funded a 4-stage clinical development plan (CDP). Stage 1, encompassing six trials and completed in 2015, showed that direct venous inoculation of PfSPZ Vaccine was safe and well tolerated, and demonstrated high-level protection against CHMI after 3 doses of vaccine and durable (6 month) protection against naturally transmitted malaria in Africa. Now 11 new trials involving ~1,500 adult and pediatric subjects are underway or will soon start in the USA, Germany, Mali, Burkina Faso, Ghana, Tanzania, Kenya, and Equatorial Guinea (CDP Stage 2). These trials extend testing to infants and children and aim to finalize highly protective regimens for Phase 3 testing (CDP Stage 3). By mid- 2018, Sanaria will submit a Biologics License Application (BLA) to the FDA for an initial indication to protect adult travelers from malaria, and a year later will extend the indication for use in malaria endemic areas. A major objective is to conduct mass vaccination administration (MVA) campaigns in endemic populations to achieve regional malaria elimination, the first such campaign slated for the >250,000 residents of Bioko Island, Equatorial Guinea (Stage 4 of the CDP). To support this ambitious plan, Sanaria is scaling up manufacturing and improving its manufacturing facility to meet phase 3 and launch compliance. However there are critically important, unfunded components that are key to rapid uptake by the travelers market post-licensure. These are addressed in this CRPP project through five specific aims: 1) Conduct a market assessment and develop a strategic plan; 2) Create a commercial development plan; 3) Develop infrastructure components and equipment for liquid nitrogen vapor phase (LNVP) delivery of PfSPZ Vaccine; 4) Model distribution logistics, and 5) Test LNVP cold chain distribution to travel clinics to establish operational readiness. The overarching goal is to position Sanaria to market and distribute vaccine immediately after BLA approval and thus to start generating funds as rapidly as possible in order to finance the increased scale-up and delivery needed to support use of the vaccine in MVA campaigns in malaria endemic areas. Sales for use in travelers will initially target the DoD, State Department, Peace Corps, mining and energy industry companies, and large, multi-site travel clinics. Funding of this proposal will significantly shorten the time to market following product licensure and launch and will increase the likelihood of success. This will lead to sales, income and profits earlier than otherwise possible, and ultimately lead to saving many lives.
