Symposium by Sanaria, USA

PfSPZ-Based Malaria Vaccines from Concept to Licensure

The development of an effective malaria vaccine has proven elusive, despite decades of effort. The most advanced candidate, RTS,S/AS01B is being considered for licensure in Africa, but provides only partial protection against clinical disease and little or no lasting protection against infection. Moreover, intensive use of currently available tools for malaria control, including insecticide-impregnated bed nets, indoor residual spraying of insecticides, intermittent treatment of vulnerable populations such as infants and pregnant women, and rapid case finding and treatment, have achieved only modest reductions in malaria-related morbidity in endemic areas, and are insufficient to halt transmission. A highly effective vaccine is urgently needed. In this setting, Sanaria Inc. has developed the world's first whole sporozoite (SPZ)-based malaria vaccines for parenteral injection, and demonstrated 100% protection against the vaccine-strain Plasmodium falciparum (Pf) parasite by controlled human malaria infection (CHMI), and the highest protection ever recorded against infection in the field. Eight trials of two related PfSPZ vaccine candidates are completed or ongoing, and 11 more are scheduled to begin in 9 countries in the next few months. These studies, designed to optimize immunization regimens for these vaccines, aim for long-lasting (e.g., 6 month) high-level protection against heterologous CHMI and against naturally acquired infection in the field. Manufactured according to GMPs, extremely safe and well tolerated, causing essentially no adverse events at current doses, and suitable for transport to remote locations, these vaccines are poised to fill the gap in the malaria control toolkit, and enable regional malaria elimination through mass administration campaigns. In this symposium, Sanaria staff will describe the fascinating story of the development of these award-winning vaccine candidates, including manufacturing, cryostabilization, cold chain distribution, regulatory strategies, clinical development, immunological correlates of protection, and our international partnerships and strategy for licensure to prevent malaria in travelers and in persons living in endemic areas, and eventually to achieve regional malaria elimination and worldwide eradication.

1. Introduction: Stephen L. Hoffman, MD, Chief Executive Officer and Chief Scientific Officer
2. Challenges and Successes in Developing a New GMP Manufacturing Process: Aseptic, Purified, Cryopreserved Malaria Sporozoites from Mosquitoes. B. Kim Lee Sim, PhD, Executive Vice President for Process Development and Manufacturing
3. Creating a New, Improved, Cost-Effective Distribution System for a Live, Whole Eukaryotic Cell Vaccine: Liquid Nitrogen Vapor Phase Storage for Human Vaccines. Eric R. James, PhD, Head, Vaccine Stabilization and Logistics
4. The Road Less Traveled: the Pathway to Licensure of a Malaria Vaccine for Travelers and Elimination Campaigns, Regulatory Obstacles and Opportunities Encountered on the Way. Tooba Murshedkar, MS, Associate Director Regulatory Affairs
5. Clinical Development of Plasmodium falciparum Sporozoite (PfSPZ)-Based Products: A Multistage Clinical Development Plan spanning 15 sites in the USA and 10 Countries in Africa and Europe. Thomas L Richie, MD PhD, Chief Medical Officer
6. Using Immunology and Systems Biology to Optimize PfSPZ-based Vaccine Regimens. Sumana Chakravarty, PhD, Senior Director, Sporozoite Extraction, Immunology and Model Systems
7. A Collaborative Approach to Success. The International PfSPZ Consortium (I-PfSPZ-C). Peter F. Billingsley, PhD, Vice President International Projects and Strategy