H5N1 pandemic influenza vaccine (NIBRG-14)

H5N1 pandemic influenza vaccine (NIBRG-14) is an inactivated monovalent vaccine derived from the A/Vietnam/1194/2004 (H5N1) virus strain using reverse genetics technology. Developed primarily to address the threat of an H5N1 influenza pandemic, the vaccine contains the hemagglutinin (HA) and neuraminidase (NA) antigens from the H5N1 virus. The NIBRG-14 strain was engineered by the National Institute for Biological Standards and Control (NIBSC) to be non-pathogenic in chickens while maintaining the antigenic properties of the wild-type virus. Clinical trials conducted by various sponsors, including Sanofi Pasteur and GSK, evaluated the vaccine's safety and immunogenicity, often testing different dosages and the inclusion of adjuvants like aluminum hydroxide or oil-in-water emulsions (e.g., MF59 or AS03) to enhance the immune response. Sanofi Pasteur's version of this vaccine was the first H5N1 vaccine to receive FDA approval in 2007 for the US Strategic National Stockpile.

Brand names

Humenza

Other names

H5N1 influenza vaccineH-5N1 influenza vaccineH 5N1 influenza vaccineA/Vietnam/1194/2004 (H5N1) vaccinePrepandemic influenza vaccine (H5N1)