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Lancet:登革热疫苗二期临床试验成功

  1. 疫苗
  2. 病毒株
  3. 登革热

来源:新华网 2012-11-18 11:34

9月11日,英国医学刊物《柳叶刀》(Lancet)刊登的报告说,临床试验结果表明,法国疫苗生产商赛诺菲-巴斯德公司研发的登革热疫苗对3种登革热病毒株有预防效果,是一种安全有效的登革热疫苗。 登革热是一种由蚊子传播的急性病毒性传染病,多在热带地区传播,典型症状包括发烧、头痛和关节痛。登革热病毒有4种血清型,人体受到其中任何一种感染后不会对其他3种产生抵抗力。迄今尚无专门预防登革热的疫苗投入使用。

9月11日,英国医学刊物《柳叶刀》(Lancet)刊登的报告说,临床试验结果表明,法国疫苗生产商赛诺菲-巴斯德公司研发的登革热疫苗对3种登革热病毒株有预防效果,是一种安全有效的登革热疫苗。

登革热是一种由蚊子传播的急性病毒性传染病,多在热带地区传播,典型症状包括发烧、头痛和关节痛。登革热病毒有4种血清型,人体受到其中任何一种感染后不会对其他3种产生抵抗力。迄今尚无专门预防登革热的疫苗投入使用。

法国赛诺菲-安万特集团旗下从事疫苗研发和生产的赛诺菲-巴斯德公司11日发表公报说,在泰国进行的针对4000多名4岁至11岁儿童的二期临床试验结果表明,该公司研发的疫苗对3种登革热病毒株有预防效果,研究人员正在分析疫苗难以预防第四种病毒株的原因。

公报还说,该公司正在对10个亚洲和拉美国家的3.1万名儿童和青少年进行大规模的三期临床试验,以更好地了解该疫苗在不同流行病学环境下和在更广泛人群中的效力。

据世界卫生组织估计,全球每年有5000万至1亿人感染登革热,其中约50万例是较严重的出血性登革热病例,这种登革热的死亡率较高。

《柳叶刀》杂志认为,赛诺菲-巴斯德研发的“CYD-TDV”活性减毒疫苗有助于实现世卫组织提出的到2020年将登革热死亡率降低50%的目标。(生物谷Bioon.com)

Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial

Prof Arunee Sabchareon MD a, Dr Derek Wallace MB BS b , Chukiat Sirivichayakul MD a, Kriengsak Limkittikul MD a, Pornthep Chanthavanich MD a, Saravudh Suvannadabba MD c, Vithaya Jiwariyavej MD d, Wut Dulyachai MD d, Prof Krisana Pengsaa MD a, T Anh Wartel MD e, Annick Moureau MS f, Melanie Saville MB BS f, Alain Bouckenooghe MD b, Simonetta Viviani MD f, Nadia G Tornieporth MD h, Jean Lang MD g

Summary

Background

Roughly half the world's population live in dengue-endemic countries, but no vaccine is licensed. We investigated the efficacy of a recombinant, live, attenuated tetravalent dengue vaccine.

Methods

In this observer-masked, randomised, controlled, monocentre, phase 2b, proof-of-concept trial, healthy Thai schoolchildren aged 4—11 years were randomly assigned (2:1) to receive three injections of dengue vaccine or control (rabies vaccine or placebo) at months 0, 6, and 12. Randomisation was by computer-generated permuted blocks of six and participants were assigned with an interactive response system. Participants were actively followed up until month 25. All acute febrile illnesses were investigated. Dengue viraemia was confirmed by serotype-specific RT-PCR and non-structural protein 1 ELISA. The primary objective was to assess protective efficacy against virologically confirmed, symptomatic dengue, irrespective of severity or serotype, occurring 1 month or longer after the third injection (per-protocol analysis). This trial is registered at ClinicalTrials.gov, NCT00842530.

Findings

4002 participants were assigned to vaccine (n=2669) or control (n=1333). 3673 were included in the primary analysis (2452 vaccine, 1221 control). 134 cases of virologically confirmed dengue occurred during the study. Efficacy was 30·2% (95% CI ?13·4 to 56·6), and differed by serotype. Dengue vaccine was well tolerated, with no safety signals after 2 years of follow-up after the first dose.

Interpretation

These data show for the first time that a safe vaccine against dengue is possible. Ongoing large-scale phase 3 studies in various epidemiological settings will provide pivotal data for the CYD dengue vaccine candidate.

Funding

Sanofi Pasteur.

 

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