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首页> 外文期刊>Vaccine >A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali
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A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali

机译：马里儿童血液阶段AMA1-C1 / Alhydrogel疟疾疫苗的随机对照2期试验

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摘要

A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel (R) Participants were healthy children 2-3 years old living in or near the village of Bancoumana. Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/mu L/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin <8.5 g/dL, in the direction of lower hemoglobin in the children who received AMA1-C1, although these differences were not significant after correction for multiple tests. These differences were not seen in the second year of transmission.
机译：进行了一项双盲，随机，对照的2期临床试验，评估了候选疫苗Apical Membrane Antigen 1-Combination 1（AMA1-C1）和Alhydrogel（R）佐剂的安全性，免疫原性和生物学影响参与者为健康儿童2-3岁，居住在Bancoumana村内或附近。马里。共有300名儿童接受了研究疫苗或对照疫苗。接种疫苗对主要终点没有影响，寄生虫的发生频率以发作> 3000 /μL/天的风险来衡量。在临床疟疾期间，疫苗接种对血红蛋白水平有负面影响，平均血红蛋白发生率<8.5 g / dL，在接受AMA1-C1的患儿中，血红蛋白水平较低，尽管校正后这些差异并不明显多次测试。在传播的第二年没有看到这些差异。

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