Safety and immunogenicity of Sinovac's prototype pandemic influenza H5N1 vaccines: a review on clinical trials.
Sinovac Biotech started to develop prototype pandemic influenza H5N1 vaccines in March 2004. On 2 April 2008, Sinovac's inactivated, aluminium-adjuvanted, whole-virion prototype pandemic influenza A (H5N1) vaccine (PanFlu) was granted production licensure by the China regulatory authority State Food and Drug Administration. The whole-virion H5N1 vaccine was manufactured in embryonated hens' eggs using the reassortant strain NIBRG-14 (A/Vietnam/1194/2004-A/PR/8/34) as vaccine virus. It showed good safety, immunogenicity and cross-reactivity in immunologically naïve adults. In primed adults, the vaccine induced a strong booster response. Plasma from a vaccinated individual showed a beneficial effect following passive immunotherapy of an H5N1 human infection case. This article reviews the process, status and results of clinical evaluation of Sinovac's whole- and split-virion H5N1 vaccines by focusing on the whole-virion vaccine.
Qiu
Yuan-Zheng
YZ
Sinovac Biotech Co. Ltd, No. 39 Shangdi Western Road, Haidian District, Beijing, China.
Yin
Wei-Dong
WD
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002681:China; D003429:Cross Reactions; D004196:Disease Outbreaks / Q000517:prevention & control*; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008875:Middle Aged; D016865:Reassortant Viruses / Q000276:immunology; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated