Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients

Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. Antiviral drugs, such as oseltamivir or zanamivir, may be effective in treating cases of swine flu, but large-scale immunization is an essential approach of controlling the pandemic.Although preliminary evidence from a matched case-control study suggests some protection from the 2008-9 trivalent inactivated vaccine against pandemic influenza A/H1N1 2009, particularly severe forms of the disease. A vaccine against H1N1 is expected to be the most effective tool for controlling influenza A (H1N1) infection.In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China.The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine without adjuvant when administered at the 15 ug dose.The primary immunogenicity objective is to assess the hemagglutinin antibody and neutralizing antibody response following split- virion inactivated A(H1N1) vaccine without adjuvant. Participants 148 healthy persons age 18-60 years who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is an observational, Phase II study in healthy males and non-pregnant females, aged 18-60 years.This study is designed to investigate the safety and immunogenicity of an inactivated influenza H1N1 virus vaccine after approved by the Chinese Food and Drug Administration.Following immunization, safety will be measured by assessment of adverse events through 21 days. Immunogenicity testing will be hemagglutination inhibition (HI) assays and microneutralization (MN) assays on serum obtained on the day 0,7 and 21 after vaccination.In addition, we will take clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with H1N1 vaccines to cure critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1. According to the Blood Donation Law of the People's Republic of China, the blood donation shall follow principle of voluntary.The donors should be healthy persons inoculated with specific H1N1 vaccine and their titer of H1N1 hemagglutination inhibition antibody must be 1：320 or more than after examination (the kit shall be provided by the WHO) by Shanghai Municipal Center for Disease Control and Prevention.