The application's broad, long-term objectives are: a) upgrade usefully and standardizing the laboratory system for necessary facilities in Flu vaccine production; b) promote effectively the avian flu A/H5N1 virus pandemic prevention in Vietnam.
Specific aims : a) evaluation of safety and immunogenic of Avian Flu type A/H5N1 vaccine developed by VABIOTECH, Vietnam (phase I & phase II); b) building capacity for scaling up production of the vaccine for preventing avian flu type A infectious and dangerous disease - H5N1. Measurable outcomes of the program will be in alignment with the following performance goal for the Coordinating Center for Infectious Diseases: Protect Americans from Infectious Diseases-Influenza. Project design and methods: a) preparing the capacity for scaling up production (materials, supplies, equipments); b) production of pilot investigational lots of H5N1 vaccine and lot release; c) toxicology study of clinical lots of H5N1 vaccine in rabbits; d) validation of release testing such as SRID for vaccine potency; e) validation of manufacturing equipment and process; f) clinical trial phase I+II; g) comparative study with other vaccine; h) evaluation of safety and immunogenicity in human by follow-up adverse reactions and analysis of serum samples for neutralizing and heagglutinin -inhibition antibodies to H5N1 virus. Measurable outcomes of this project will address a critical need in an area may be ground-zero for an H5N1 virus pandemic and provide the foundation for adequate vaccine capacity to supply for the whole country. The results of this research will promote effectively the avian flu A/H5N1 pandemic preparedness in Vietnam. ? ?
