PDF(Pubmed)
Abstract：
The TAK-003 dengue vaccine was licensed in Europe in December 2022, and the official recommendations from most EU countries are still under formulation. To support policymakers, we performed a meta-analysis to quantify TAK-003\'s immunogenicity, efficacy and safety among seronegative and seropositive populations after the administration of one or two vaccine doses. We included trials retrieved from MEDLINE, Scopus and ClinicalTrials.gov. The outcomes were the rates of seroconversion, virologically confirmed dengue fever and serious adverse events after each vaccine dose. Data were combined using random-effect proportion or head-to-head meta-analyses. We retrieved a total of 19 datasets, including >20,000 participants. TAK-003 showed an excellent safety profile, and the immunogenicity after two doses against the four DENV serotypes was ≥90% among both adults and children/adolescents who were either seronegative or seropositive at baseline. A single dose was able to elicit a high immunogenic response among adults (≥70%) and children/adolescents (≥90%). The primary two-dose immunization course halved the risk of all types of virologically confirmed dengue fever among seropositive children/adolescents, but seronegative minors were only protected against the diseases caused by DENV-1 and DENV-2. Overall, the results support the use of TAK-003 for the prevention of dengue fever in the pediatric population of endemic countries. Uncertainties remain on the use of a single vaccine dose in non-endemic countries.
摘要：
TAK-003登革热疫苗于2022年12月在欧洲获得许可，大多数欧盟国家的官方建议仍在制定中。为了支持政策制定者，我们进行了荟萃分析来量化TAK-003的免疫原性，血清阴性和血清阳性人群在服用一或两剂疫苗后的有效性和安全性。我们纳入了从MEDLINE检索的试验，ScopusandClinicalTrials.gov.结果是血清转换率，病毒学证实登革热和严重不良事件后，每次疫苗剂量。使用随机效应比例或头对头荟萃分析合并数据。我们总共检索了19个数据集，包括超过20,000名参与者。TAK-003显示出良好的安全性，在基线时血清阴性或血清阳性的成人和儿童/青少年中，针对四种DENV血清型的两种剂量后的免疫原性≥90％。单剂量能够在成人（≥70％）和儿童/青少年（≥90％）中引起高免疫原性反应。在血清反应呈阳性的儿童/青少年中，初次两次剂量免疫接种将所有类型的病毒学确诊登革热的风险减半。但是血清阴性的未成年人仅受到DENV-1和DENV-2引起的疾病的保护。总的来说,结果支持在流行国家的儿科人群中使用TAK-003预防登革热.在非流行国家使用单一疫苗剂量仍然存在不确定性。
