联合疫苗应用现状及评价

Application Status and Evaluation of Combination Vaccines

联合疫苗含有两种或多种免疫原(活的、灭活的病原体或者提纯的抗原),用于预防多种疾病或由同一病原体的不同亚型或血清型引起的疾病,可以避免常规免疫多次注射的问题。然而和单价疫苗相比,联合疫苗研发的复杂性大大增加,将多种免疫原混合到一起进行免疫时不同免疫原间可能因为物理、化学和免疫学机制而干扰其他免疫原的免疫反应,此外佐剂和防腐剂等非活性成分也可能对联合后的活性成分产生影响,这就对联合疫苗的评价提出了特别的要求。现就联合疫苗的研究应用现状、临床评价和发展前景等方面做一综述。

A combination vaccine which consists of ≥ 2 immunogens is intended to provide protection against two or more diseases or against multiple serotypes of a single disease. The use of combination vaccines decrease the number of vaccine injections in the regular immunization schedules. However, the development of combination vaccines is more complicated than monovalent vaccines, preservatives and adjuvants used with one component may alter the potency of other components. Physical, chemical, and biological interactions between the components of combination vaccines must be considered to avoid detrimental effects on safety or efficacy. Therefore combination vaccines present unique challenges for product evaluation. This paper presents a review of research application status, the evaluation of effectiveness and safety, as well as development prospects on combination vaccines.