Esen Meral, Kremsner Peter G, Schleucher Regina, Gässler Michael, Imoukhuede Egeruan Babatunde, Imbault Nathalie, Leroy Odile, Jepsen Søren, Knudsen Birgitte Walther, Schumm Michael, Knobloch Jürgen, Theisen Michael, Mordmüller Benjamin
University of Tübingen, Institute of Tropical Medicine, Wilhelmstrasse 27, D-72074 Tübingen, Germany.
Vaccine. 2009 Nov 16;27(49):6862-8. doi: 10.1016/j.vaccine.2009.09.011. Epub 2009 Sep 13.
Malaria is a major public health problem in Sub-Saharan Africa. In highly endemic regions infants, children and pregnant women are mostly affected. An effective malaria vaccine would complement existing malaria control strategies because it can be integrated in existing immunization programs easily. Here we present the results of the first phase Ia clinical trial of GMZ2 adjuvanted in aluminium hydroxide. GMZ2 is a malaria vaccine candidate, designed upon the rationale to induce immune responses against asexual blood stages of Plasmodium falciparum similar to those encountered in semi-immune individuals. Ten, 30 and 100 microg of GMZ2 were well tolerated in 30 healthy malaria-naïve German volunteers when given three times in monthly intervals. Antigen-specific antibodies as well as memory B-cells were induced and detectable throughout the one year follow-up of the study. We conclude that GMZ2 is a safe and immunogenic malaria vaccine candidate suitable for further clinical development.
疟疾是撒哈拉以南非洲地区的一个主要公共卫生问题。在高度流行地区,婴儿、儿童和孕妇受影响最为严重。一种有效的疟疾疫苗将补充现有的疟疾控制策略,因为它可以很容易地纳入现有的免疫规划。在此,我们展示了氢氧化铝佐剂GMZ2的I期a临床试验结果。GMZ2是一种疟疾候选疫苗,其设计原理是诱导针对恶性疟原虫无性血液阶段的免疫反应,类似于半免疫个体所产生的免疫反应。当以每月一次的间隔给药三次时,10、30和100微克的GMZ2在30名未感染疟疾的健康德国志愿者中耐受性良好。在该研究为期一年的随访期间,诱导并检测到了抗原特异性抗体以及记忆B细胞。我们得出结论,GMZ2是一种安全且具有免疫原性的疟疾候选疫苗,适合进一步进行临床开发。