Phase II clinical trial of Novavax respiratory syncytial virus vaccine shows promising results


Release time:

2018-05-24

Recently, NOVAVAX announced that its first respiratory syncytial virus vaccine, RSV F (RSV F protein recombinant nanoparticle vaccine), which it led the development of, has obtained good results in a phase II trial of elderly patients aged 60 and above with respiratory syncytial virus (RSV). Outstanding performance. The results showed that the RSV F vaccine was well tolerated and achieved both the primary and secondary clinical endpoints.

  Recently, NOVAVAX announced that its first respiratory syncytial virus vaccine, RSV F (RSV F protein recombinant nanoparticle vaccine), which it led the development of, has obtained good results in a phase II trial of elderly patients aged 60 and above with respiratory syncytial virus (RSV). Outstanding performance. The results showed that the RSV F vaccine was well tolerated and achieved both the primary and secondary clinical endpoints.

  This randomized, investigator-blinded, placebo-controlled Phase II clinical trial of 1,600 elderly people was jointly completed by 10 medical research centers in the United States. The main content of this trial is to evaluate the safety and effectiveness of the RSV F vaccine and to conduct a prospective epidemiological study of RSV in the elderly. In the trial, subjects were divided into groups and given a 135 microgram dose of RSV F vaccine and a placebo respectively, and the safety and immunogenicity of the vaccine were evaluated.

  The results showed that the probability of preventing RSV initial symptoms and RSV lower respiratory tract infection among the elderly reached 44% and 46% respectively, which was slightly better than the preventive effect of Streptococcus pneumoniae and seasonal influenza vaccines. The epidemiological results show that among the surveyed group, 4.9% of the infected elderly people showed early symptoms of RSV (such as rhinitis, dry cough and mild fever, etc.), and nearly 95% of the infected people showed lower respiratory tract infection. The treatment of RSV infection is serious. Sex can be known from this.

  Gregory Glenn, senior vice president of Novavax R&D, said that the RSV F vaccine has achieved good efficacy in elderly patients and effectively alleviated complications such as lower respiratory tract infection and dyspnea caused by RSV, which will greatly promote the progress of research and development in the field of RSV treatment.

  Respiratory syncytial virus infection (RSV) is an infectious viral disease and the most important cause of severe respiratory diseases in infants and the elderly in China. The main manifestations are lower respiratory tract infection, bronchitis, viral pneumonia, etc.

  There is currently no vaccine that can prevent the disease. Currently, there are only two drugs (palivizumab and ribavirin) available to patients, and these two drugs also have huge shortcomings. Therefore, if Novavax's RSV F vaccine can successfully pass the clinical trial, it may lead the field of RSV infection treatment, and its commercial prospects are unlimited.

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