小柯机器人

四价登革热疫苗对健康儿童青少年的疗效观察
2019-11-08 20:37

新加坡武田疫苗公司的Shibadas Biswal小组,研制了四价登革热疫苗对健康儿童和青少年的疗效。2019年11月6日出版的《新英格兰医学杂志》发表了这项成果。

登革热是一种通过蚊子传播的病毒性疾病,被世界卫生组织列为2019年全球健康十大威胁。

研究组在亚洲和拉丁美洲登革热肆虐的地区进行了一项登革热候选疫苗(TAK-003)的临床3期随机试验,将4-16岁的健康儿童和青少年按2:1随机分配,间隔3个月接受两剂疫苗或安慰剂。采用特异性逆转录聚合酶链反应对登革热病毒血清型进行诊断。

在接受至少一剂疫苗或安慰剂的20071名健康受试者中,94.8%同时接受了两种注射,并被纳入分析。安全人群的总疫苗效力为80.9%,其中疫苗组的发病率为每100人年0.5例,而安慰剂组为2.5例。按研究协议分析,疫苗效力为80.2%,登革热导致的住院减少了95.4%。对27.7%基线血清阴性的人群进行有计划的探索性分析,疫苗效力为74.9%。该效力趋势因血清型不同而不同。疫苗组和安慰剂组的严重不良事件发生率相差无几。

总之,在登革热肆虐的国家,TAK-003可有效对抗有症状的登革热。

附:英文原文

Title: Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents

Author: Shibadas Biswal, M.D.,, Humberto Reynales, M.D., Ph.D.,, Xavier Saez-Llorens, M.D.,, Pio Lopez, M.D.,, Charissa Borja-Tabora, M.D.,, Pope Kosalaraksa, M.D.,, Chukiat Sirivichayakul, M.D.,, Veerachai Watanaveeradej, M.D.,, Luis Rivera, M.D.,, Felix Espinoza, M.D.,, LakKumar Fernando, M.D.,, Reynaldo Dietze, M.D.,, Kleber Luz, M.D.,, Rivaldo Venancio da Cunha, M.D.,, José Jimeno, M.D.,, Eduardo López-Medina, M.D.,, Astrid Borkowski, M.D., Ph.D.,, Manja Brose, M.Sc.,, Martina Rauscher, Ph.D.,, Inge LeFevre, M.D.,, Svetlana Bizjajeva, Ph.D.,, Lulu Bravo, M.D.,, and Derek Wallace, M.B., B.S.

Issue&Volume: 2019-11-06

Abstract:

Background

Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019.

Methods

We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart. Participants presenting with febrile illness were tested for virologically confirmed dengue by serotype-specific reverse-transcriptase polymerase chain reaction. The primary end point was overall vaccine efficacy in preventing virologically confirmed dengue caused by any dengue virus serotype.

Results

Of the 20,071 participants who were given at least one dose of vaccine or placebo (safety population), 19,021 (94.8%) received both injections and were included in the per-protocol analysis. The overall vaccine efficacy in the safety population was 80.9% (95% confidence interval [CI], 75.2 to 85.3; 78 cases per 13,380 [0.5 per 100 person-years] in the vaccine group vs. 199 cases per 6687 [2.5 per 100 person-years] in the placebo group). In the per-protocol analyses, vaccine efficacy was 80.2% (95% CI, 73.3 to 85.3; 61 cases of virologically confirmed dengue in the vaccine group vs. 149 cases in the placebo group), with 95.4% efficacy against dengue leading to hospitalization (95% CI, 88.4 to 98.2; 5 hospitalizations in the vaccine group vs. 53 hospitalizations in the placebo group). Planned exploratory analyses involving the 27.7% of the per-protocol population that was seronegative at baseline showed vaccine efficacy of 74.9% (95% CI, 57.0 to 85.4; 20 cases of virologically confirmed dengue in the vaccine group vs. 39 cases in the placebo group). Efficacy trends varied according to serotype. The incidence of serious adverse events was similar in the vaccine group and placebo group (3.1% and 3.8%, respectively).

Conclusions

TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic.

DOI: 10.1056/NEJMoa1903869

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1903869

 

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:176.079
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home


本期文章:《新英格兰医学杂志》:Online/在线发表

分享到:

0