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Seasonal Malaria Vaccination with or without Seasonal Malaria Chemoprevention
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2021-08-25 , DOI: 10.1056/nejmoa2026330
Daniel Chandramohan 1 , Issaka Zongo 1 , Issaka Sagara 1 , Matthew Cairns 1 , Rakiswendé-Serge Yerbanga 1 , Modibo Diarra 1 , Frédéric Nikièma 1 , Amadou Tapily 1 , Frédéric Sompougdou 1 , Djibrilla Issiaka 1 , Charles Zoungrana 1 , Koualy Sanogo 1 , Alassane Haro 1 , Mahamadou Kaya 1 , Abdoul-Aziz Sienou 1 , Seydou Traore 1 , Almahamoudou Mahamar 1 , Ismaila Thera 1 , Kalifa Diarra 1 , Amagana Dolo 1 , Irene Kuepfer 1 , Paul Snell 1 , Paul Milligan 1 , Christian Ockenhouse 1 , Opokua Ofori-Anyinam 1 , Halidou Tinto 1 , Abdoulaye Djimde 1 , Jean-Bosco Ouédraogo 1 , Alassane Dicko 1 , Brian Greenwood 1
Affiliation  

Background

Malaria control remains a challenge in many parts of the Sahel and sub-Sahel regions of Africa.

Methods

We conducted an individually randomized, controlled trial to assess whether seasonal vaccination with RTS,S/AS01E was noninferior to chemoprevention in preventing uncomplicated malaria and whether the two interventions combined were superior to either one alone in preventing uncomplicated malaria and severe malaria-related outcomes.

Results

We randomly assigned 6861 children 5 to 17 months of age to receive sulfadoxine–pyrimethamine and amodiaquine (2287 children [chemoprevention-alone group]), RTS,S/AS01E (2288 children [vaccine-alone group]), or chemoprevention and RTS,S/AS01E (2286 children [combination group]). Of these, 1965, 1988, and 1967 children in the three groups, respectively, received the first dose of the assigned intervention and were followed for 3 years. Febrile seizure developed in 5 children the day after receipt of the vaccine, but the children recovered and had no sequelae. There were 305 events of uncomplicated clinical malaria per 1000 person-years at risk in the chemoprevention-alone group, 278 events per 1000 person-years in the vaccine-alone group, and 113 events per 1000 person-years in the combination group. The hazard ratio for the protective efficacy of RTS,S/AS01E as compared with chemoprevention was 0.92 (95% confidence interval [CI], 0.84 to 1.01), which excluded the prespecified noninferiority margin of 1.20. The protective efficacy of the combination as compared with chemoprevention alone was 62.8% (95% CI, 58.4 to 66.8) against clinical malaria, 70.5% (95% CI, 41.9 to 85.0) against hospital admission with severe malaria according to the World Health Organization definition, and 72.9% (95% CI, 2.9 to 92.4) against death from malaria. The protective efficacy of the combination as compared with the vaccine alone against these outcomes was 59.6% (95% CI, 54.7 to 64.0), 70.6% (95% CI, 42.3 to 85.0), and 75.3% (95% CI, 12.5 to 93.0), respectively.

Conclusions

Administration of RTS,S/AS01E was noninferior to chemoprevention in preventing uncomplicated malaria. The combination of these interventions resulted in a substantially lower incidence of uncomplicated malaria, severe malaria, and death from malaria than either intervention alone. (Funded by the Joint Global Health Trials and PATH; ClinicalTrials.gov number, NCT03143218.)



中文翻译:

季节性疟疾疫苗接种,有或没有季节性疟疾化学预防

背景

在非洲萨赫勒和萨赫勒以南地区的许多地区,疟疾控制仍然是一项挑战。

方法

我们进行了一项单独的随机对照试验,以评估 RTS、S/AS01 E季节性疫苗接种在预防单纯性疟疾方面是否不劣于化学预防,以及两种干预措施相结合在预防单纯性疟疾和严重疟疾相关结局方面是否优于单独一种干预措施.

结果

我们将 6861 名 5 至 17 个月大的儿童随机分配接受磺胺多辛-乙胺嘧啶和阿莫地喹(2287 名儿童 [化学预防单独组])、RTS、S/AS01 E(2288 名儿童 [单独疫苗组])或化学预防和 RTS ,S/AS01 E(2286名儿童[组合组])。其中,三组中的 1965、1988 和 1967 名儿童分别接受了第一剂指定干预措施,并随访了 3 年。5名儿童在接种疫苗后的第二天出现热性惊厥,但这些儿童都康复了,没有后遗症。单独化学预防组每 1000 人年有 305 起无并发症临床疟疾事件,单独接种疫苗组每 1000 人年 278 起事件,联合组每 1000 人年 113 起事件。RTS,S/AS01 E保护效果的风险比与化学预防相比为 0.92(95% 置信区间 [CI],0.84 至 1.01),其中排除了预设的非劣效性界值 1.20。根据世界卫生组织的数据,与单独的化学预防相比,联合用药对临床疟疾的保护效力为 62.8%(95% CI,58.4 至 66.8),对严重疟疾住院的保护效力为 70.5%(95% CI,41.9 至 85.0)定义,以及 72.9% (95% CI, 2.9 to 92.4) 反对死于疟疾。与单独使用疫苗相比,联合疫苗对这些结果的保护效力分别为 59.6%(95% CI,54.7 至 64.0)、70.6%(95% CI,42.3 至 85.0)和 75.3%(95% CI,12.5 至 85.0)。 93.0),分别。

结论

RTS,S/AS01 E在预防单纯性疟疾方面不劣于化学预防。这些干预措施的组合导致单纯性疟疾、重症疟疾和疟疾死亡的发生率大大低于单独的干预措施。(由联合全球健康试验和 PATH 资助;ClinicalTrials.gov 编号为 NCT03143218。)

更新日期:2021-08-26
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