title: [Immunological surrogate endpoints to evaluate vaccine efficacy].
abstract: An immunological surrogate endpoints is a vaccine-induced immune response (either humoral or cellular immune) that predicts protection against clinical endpoints (infection or disease), and can be used to evaluate vaccine efficacy in clinical vaccine trials. Compared with field efficacy trials observing clinical endpoints, immunological vaccine trials could reduce the sample size or shorten the duration of a trial, which promote the license and development of new candidate vaccines. For these reasons, establishing immunological surrogate endpoints is one of 14 Grand Challenges of Global Health of the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation. From two parts of definition and statistical methods for evaluation of surrogate endpoints, this review provides a more comprehensive description.
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Nanjing Medical University, Nanjing 210009, China.
authors.forename: Pengfei
authors.initials: P
authors.lastname: Jin
authors.forename: Jingxin
authors.initials: J
authors.lastname: Li
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Email: jszfc@vip.sina.com.
authors.forename: Fengcai
authors.initials: F
authors.lastname: Zhu
mesh_terms: D015415:Biomarkers; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D006801:Humans; D012107:Research Design; D016896:Treatment Outcome; D014612:Vaccines / Q000008:administration & dosage* / Q000276:immunology
chemical_list: D015415:Biomarkers; D014612:Vaccines