China's Human Avian Influenza Vaccine Phase II Clinical TrialS Completed

China's "human avian influenza vaccine development" task force announced on the 24th, by Beijing Kexing Biological Products Co., Ltdand China'sDiseasePrevention and Control Center jointly developed human avian influenza vaccine - pandemic influenza all-virus inactivated vaccine Phase II clinical trial has been completed, preliminary analysis results show that the vaccine is safe and effective for human sonOn December 22this, the results of Phase II clinical trials were revealedThe results showthat that the vaccine used in clinical trials of 3 antigen doses can induce the human body to produce a certain degree of antibody, of which 10 mg and 15 mg dose of the vaccine protective antibody positive rate,antibody impotence rate and antibody geometric average tint(
GMT) increase multiple of the three indicators are up to the internationally recognized vaccine evaluationstandard, showing that the vaccine has a good immunogenicity on human bodyFrom the observation of the subjects' local and systemicadverse reactions, no seriousadverse reactions, indicating that the vaccine had good safety At the same time, the human-to-human flu lysis vaccine developed by Beijing Kexing and the China Center for Disease Control and Prevention also completed Phase I clinical trials, including children , adults and older adults in a number of age groups were given different doses of the experimental vaccine, preliminary results show that the vaccine has good safety The development of avian influenza vaccines for humans at different doses and types will provide a variety of vaccine options for preventing and controlling influenza pandemics According to the relevant person in charge of the task force, the human avian influenza vaccine phase II clinical trial is carried out under the supervision and guidance of the Food Drug Regulatory Administration, not only obtained the safe and effective data of the vaccine, but also determined the vaccine's immunization dose and procedures, providing a scientific , effective means for China to respond to the influenza pandemic The development of a human avian influenza vaccine and the successful of clinical trials have indicate that China has completed the technical reserve to respond to the influenza pandemic, is in a good position to have a vaccine reserve " The development of human avian influenza vaccine is the of China's "Fifteenth Five-Year" science and technology project, and
the 2005 2
2
2005 human avian influenza vaccine into the clinical research stage Phase I clinical trials involved 1
2
0 participants in the , and results showed that the pandemic influenza virus inactivated vaccine was safe for humans 2
September 2006, the results of the Phase I clinical trial were published in The Lancet Phase II clinical trialwas approved for drug clinical trial sandon sandon by the State Administration of Food drug supervision on April 20, 2007 and was officially implemented from September to November 2007 The trial, conducted by the Beijing Disease Center for Disease Control and Prevention, was designed with a stratified randomized double-blind trial, in which 402 subjects aged between 18 and 60 took part Since 2003, the highly pathogenic H5N1 subtype avian influenza virus has caused 340 human infections in China and other countries, of which 209 have died