Pengembangan Vaksin Hepatitis B Generasi Ke Tiga dan Vaksin Terapi Berbasis Protein Rekombinan Subunit Indonesia

AbstractIn strengthening National Innovation System (Sistem Inovasi Nasional, SINas) through im- provement of synergy, productivity and utilization of national resources as well as partner- ships with industry/private sector in research and development particularly in health sector, a hepatitis B consortium has been established. This consortium is a collaboration between several institutions including PT. Bio Farma (Persero), Lembaga Eijkman, Pusat Teknologi Farmasi dan Medika BPPT, and ITB. Development and production of recombinant protein- based hepatitis B vaccines in this consortium is a multi-year program where in 2012-2014 periods it has generated the second generation of hepatitis B vaccines. As a continuation of the program, construction of clones for expression of M HBsAg and L HBsAg in Pichia pas- toris for the third generation of hepatitis B vaccines, and development of a therapeutic hep- atitis B vaccine comprising of HBsAg and HBcAg were done in 2015. Expression of M and L HBsAg in Pichia pastoris and HBcAg in E. coli and characterization of these proteins were then completed in 2016. In 2017, the purification of the proteins, formulation develop- ment involving adjuvants, in vitro and in vivo evaluations of the formulation in animal model were performed. The expected outcome of the program is to generate the second-generation vaccine and therapeutic vaccine candidates against hepatitis B, which could be transferred to industrial applications. The vaccines that are being developed are essential in enhancing Indonesian self-reliance in combating hepatitis B disease. Besides, production of these vac- cines offers enormous economical benefits since the products can be marketed to fulfill both national and global demands.Keywords: Hepatitis B vaccine, Recombinant Protein, sHBsAg, HBcAg, M HBsAg, L HBsAg, Pichia pastoris, E.coli.