6 billion doses. So far US$600 million has been spent in efforts to develop TB vaccine candidates. Efforts to develop a live attenuated (LA) tetravalent dengue vaccine in partnership with the National Institutes of Allergy and Infectious Diseases – NIH and the Butantan Institute were reported by A. Precioso. Dengue incidence has increased 30-fold over the last 50 years with up to 100 million infections annually in over 100 endemic countries, in tropical and sub-tropical areas. The LA vaccine approach stimulates both cellular and humoral immunity, inducing
a strong memory response and durable immune response. LA vaccines for other related flaviviruses such as yellow fever and Japanese encephalitis virus have been
successfully developed and LA vaccines click here can be very economical to produce, helping to secure vaccine access. Ideally, the vaccine must confer protective immunity against all selleck chemical four dengue virus serotypes. Regarding safety, the attenuated virus must not be transmissible via mosquitoes and must show genetic and potency stability. Six monovalent candidates, developed and tested in pre-clinical and initial clinical studies in the USA, demonstrated that each of monovalent vaccine candidates was attenuated and immunogenic in mice and Rhesus macaques. The monovalent candidate vaccines, evaluated in over 750 volunteers in US, were found to be safe and immunogenic when administered as a single subcutaneous dose of
103 PFU/mL. Subjects did not develop a dengue-like illness and local reactogenicity was minimal. Studies in flavivirus-naïve adults (US) demonstrated that the tetravalent mixtures are safe and viremia remained very low. Immunogenicity measured after 90 days demonstrated multivalent seroconversion rate of 74%. Phase II, stepwise, randomized, double-blind and controlled clinical trial to evaluate the safety and immunogenicity of the lyophilized formulation of the vaccine made at Butantan started in Brazil in October 2013. L. Yang provided an overview of a successful partnership between CNBG and PATH2 for the development and global supply of a live attenuated Japanese encephalitis old (JE) vaccine at the Chengdu Institute for Biological Products (CDIBP) in China. CDIBP has one of the largest development and manufacture capabilities of biological products within CNBG with an annual production capacity for more than 100 million doses and over 950 staff. The JE project’s strategy at CDIBP, focused on improving the GMP level and achieving WHO prequalification. Critical success factors included the use of software tools, the organization of the project team, the teamwork spirit and defining the framework or rules for the project monitoring, measurement and improvement. Key milestones were defined in 2004 with an assessment by PATH, site inspection by WHO in May 2013 and prequalification in October 2013.