據(jù)新華社電 一個(gè)國(guó)際研究團(tuán)隊(duì)18日在美國(guó)西雅圖舉行的瘧疾論壇上宣布,，初步臨床試驗(yàn)結(jié)果顯示，一種名為RTS,，S的疫苗可以顯著降低兒童患瘧疾的風(fēng)險(xiǎn),。這項(xiàng)研究成果同日發(fā)表在美國(guó)《新英格蘭醫(yī)學(xué)雜志》上。
美國(guó)疾病控制和預(yù)防中心專門發(fā)表聲明對(duì)RTS,，S疫苗研究取得重大進(jìn)展表示歡迎,，并稱這一疫苗如研制成功，將挽救成千上萬(wàn)的生命,，向?qū)崿F(xiàn)瘧疾零死亡目標(biāo)又走近一步,。
RTS，S疫苗已由英國(guó)葛蘭素史克公司研發(fā)了25年,，在美國(guó)比爾和梅林達(dá)·蓋茨基金會(huì)的資助下,，疫苗的三期臨床試驗(yàn)將持續(xù)到2014年,，試驗(yàn)對(duì)象為撒哈拉以南7個(gè)非洲國(guó)家11個(gè)研究點(diǎn)的超過(guò)1.5萬(wàn)名兒童。而初步結(jié)果顯示,，在為期12個(gè)月的觀察期內(nèi),，6000名5個(gè)月至17個(gè)月幼兒注射3劑疫苗后，患瘧疾和惡性瘧疾的風(fēng)險(xiǎn)分別降低了56%和47%,。
“這些結(jié)果令人鼓舞,，但我們還有很長(zhǎng)的路要走，”領(lǐng)導(dǎo)加納一所醫(yī)院臨床試驗(yàn)的特希里·阿貝耶加當(dāng)天在論壇上宣布研究結(jié)果時(shí)如是表示,。
葛蘭素史克公司首席執(zhí)行官安德魯·威蒂在論壇上說(shuō),，大部分疫苗有效率達(dá)到90%以上才開(kāi)始上市,，因此47%的有效率顯得不是很高,，但即便這樣的有效率也能在10年內(nèi)挽救數(shù)百萬(wàn)人的生命。
威蒂表示,，葛蘭素史克已在這一疫苗上投入3億多美元,，預(yù)計(jì)將繼續(xù)投入1億美元，如果被批準(zhǔn)上市,，疫苗很可能被命名為Mosquirix,，售價(jià)為成本加5%的利潤(rùn)，其中的利潤(rùn)部分將繼續(xù)用于瘧疾研究,。
瘧疾是由瘧原蟲(chóng)引起的疾病,，通過(guò)蚊子叮咬傳播，其癥狀包括發(fā)熱,、頭痛,、嘔吐等，如不及時(shí)治療可能危及生命,。據(jù)統(tǒng)計(jì),，全球每年約有80萬(wàn)人死于瘧疾，非洲大約每30秒就有一個(gè)幼兒因瘧疾而死亡,。長(zhǎng)期以來(lái),，醫(yī)學(xué)界一直致力于瘧疾疫苗開(kāi)發(fā)，但進(jìn)展總體緩慢,，其難度遠(yuǎn)遠(yuǎn)超過(guò)病毒疫苗,。(生物谷 Bioon.com)
doi:10.1056/NEJMoa1102287
PMC:
PMID:
First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children
The RTS,S Clinical Trials Partnership
Background
An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries.
Methods
From March 2009 through January 2011, we enrolled 15,460 children in two age categories — 6 to 12 weeks of age and 5 to 17 months of age — for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories.
Results
In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64).
Conclusions
The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.)
