Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, BC, Canada.
Ann Pharmacother. 2012 Mar;46(3):384-93. doi: 10.1345/aph.1AQ634.
To summarize and evaluate the literature for Mosquirix (RTS,S) and provide insight into the therapeutic and economic controversies of this novel malaria vaccine candidate.
A systematic literature search was performed using the terms Mosquirix; RTS,S; malaria; vaccine; and Plasmodium in MEDLINE (1948-November 2011), EMBASE (1980-November 2011), International Pharmaceutical Abstracts (1970-November 2011), Google, and Google Scholar.
Clinical trials describing vaccine development, pharmacology, pharmacokinetics, efficacy, and safety were reviewed. For efficacy, clinical trials were reviewed that reported acquisition of malarial disease. Information regarding study design, population, study period, baseline characteristics, clinical outcomes, results, and assessors of quality was extracted.
Five randomized controlled trials and 4 follow-up extension studies were identified. In Phase 2 trials, vaccine efficacy rates were 33-65% in infants and 30-53% in children for preventing the first episode of clinical disease. In Phase 3 trials, vaccine efficacy was 56% in children aged 5-17 months. RTS,S reduced the number of clinical malaria episodes and prevented severe malaria in several studies. The follow-up period for vaccine efficacy ranged from 6 to 45 months. RTS,S 25 μg is administered intramuscularly as 3 injections given 1 month apart for infants and children. RTS,S appears to be generally well tolerated. A few cases of meningitis and seizures (within 7 days of vaccination) have been reported.
RTS,S has demonstrated efficacy and safety in Phase 1, 2, and 3 trials, and has the potential to decrease morbidity and mortality from malaria worldwide. Major challenges include determination of the duration of immunity, assessment of its cost-effectiveness, its use in special populations, and its dissemination in endemic regions. Pending further studies, RTS,S has the potential to become the benchmark as the first effective vaccine against malaria.
总结和评估 Mosquirix（RTS,S）的文献，并深入了解这种新型疟疾候选疫苗的治疗和经济争议。
使用 Mosquirix；RTS,S；疟疾；疫苗；和 Plasmodium 等术语在 MEDLINE（1948 年-2011 年 11 月）、EMBASE（1980 年-2011 年 11 月）、国际药学文摘（1970 年-2011 年 11 月）、Google 和 Google Scholar 中进行了系统的文献检索。
综述了描述疫苗开发、药理学、药代动力学、疗效和安全性的临床试验。对于疗效，综述了报告获得疟疾疾病的临床试验。提取了有关研究设计、人群、研究期间、基线特征、临床结果、结果和质量评估者的信息。
确定了 5 项随机对照试验和 4 项后续扩展研究。在 2 期试验中，疫苗在婴儿中的疗效率为 33-65%，在儿童中的疗效率为 30-53%，用于预防首次临床疾病发作。在 3 期试验中，疫苗在 5-17 个月的儿童中的疗效为 56%。RTS,S 在几项研究中减少了临床疟疾发作的次数并预防了严重疟疾。疫苗疗效的随访期为 6-45 个月。RTS,S 25μg 通过肌内注射，每月 1 次，共 3 次，用于婴儿和儿童。RTS,S 似乎普遍耐受良好。少数脑膜炎和癫痫发作（接种疫苗后 7 天内）的病例已报告。
RTS,S 在 1、2 和 3 期试验中已证明具有疗效和安全性，并有可能降低全球疟疾的发病率和死亡率。主要挑战包括确定免疫持续时间、评估其成本效益、在特殊人群中的使用以及在流行地区的传播。在进一步研究之前，RTS,S 有可能成为针对疟疾的第一个有效疫苗的基准。
