Initiative for Vaccine Research, WHO, Geneva, Switzerland.
Initiative for Vaccine Research, WHO, Geneva, Switzerland.
Lancet Infect Dis. 2019 Jan;19(1):e31-e38. doi: 10.1016/S1473-3099(18)30494-8. Epub 2018 Sep 5.
The Strategic Advisory Group of Experts (SAGE) on Immunization advises WHO on global policies for vaccines. In April, 2016, SAGE issued recommendations on the use of the first licenced dengue vaccine, CYD-TDV. In November, 2017, a retrospective analysis of clinical trial data, stratifying participants according to their dengue serostatus before the first vaccine dose, showed that although in high seroprevalence settings the vaccine provides overall population benefit, there was an excess risk of severe dengue in seronegative vaccinees. SAGE's working group on dengue vaccines met to discuss the new data and mainly considered two vaccination strategies: vaccination of populations with dengue seroprevalence rates above 80% or screening of individuals before vaccination, and vaccinating only seropositive individuals. We report on the deliberations that informed the recommendation of the pre-vaccination screening strategy, in April, 2018. Important research and implementation questions remain for CYD-TDV, including the development of a highly sensitive and specific rapid diagnostic test to determine serostatus, simplified immunisation schedules, and assessment of the need for booster doses.
免疫战略咨询专家组(SAGE)就疫苗相关的全球政策向世界卫生组织提供建议。2016 年 4 月,SAGE 就首个获批的登革热疫苗 CYD-TDV 的使用提出了建议。2017 年 11 月,对临床试验数据的回顾性分析,根据参与者在首次接种疫苗前的登革热血清阳性率进行分层,表明尽管在高血清流行率环境下,疫苗为整个人群带来了获益,但在血清阴性的疫苗接种者中,发生重症登革热的风险过高。SAGE 的登革热疫苗工作组开会讨论了新数据,并主要考虑了两种接种策略:在血清流行率高于 80%的人群中接种疫苗,或在接种疫苗前对个体进行筛查,并仅对血清阳性者进行接种。我们报告了 2018 年 4 月为推荐疫苗接种前筛查策略而进行的审议情况。CYD-TDV 仍存在重要的研究和实施问题,包括开发高度敏感和特异的快速诊断检测以确定血清阳性状态、简化免疫接种计划,以及评估是否需要加强剂量。