Schellenberg D M, Acosta C J, Galindo C M, Kahigwa E, Urassa H, Masanja H, Aponte J J, Schellenberg J R, Fraser-Hurt N, Lwilla F, Menendez C, Mshinda H, Tanner M, Alonso P L
Unidad de Epidemiologia y Bioestadistica, Hospital Clinic/IDIBAPS, Barcelona, Spain.
Trop Med Int Health. 1999 May;4(5):377-82. doi: 10.1046/j.1365-3156.1999.00424.x.
The most likely mechanism to deliver a malaria vaccine in African countries is through the Expanded Program of Immunization (EPI). So far only SPf66, a multistage synthetic peptide, has shown any evidence of protection in Phase III field trials. In Tanzania, SPf66 reduced the risk of clinical malaria by 31% in children aged 1-5 years. In order to progress in the critical path of vaccine development and testing towards the implementation of a new vaccine in malaria control programs, we carried out a randomized double-blind placebo controlled efficacy trial of SPf66 when given alongside the EPI scheme. Monitoring of safety and reactogenicity during this trial included detailed clinical and laboratory assessments on 98 infants and assessment of adverse effects within 1 h of vaccination for all 1207 children vaccinated. Surveillance systems monitored attendances as outpatients, admissions to hospital and fatal events in the community. No serious adverse effects were detected more frequently amongst SPf66 recipients compared to placebo. This first assessment in very young infants of a synthetic vaccine provides evidence of a good safety profile.
在非洲国家推广疟疾疫苗最有可能的机制是通过扩大免疫规划（EPI）。到目前为止，只有多阶段合成肽SPf66在III期现场试验中显示出任何保护作用的证据。在坦桑尼亚，SPf66使1至5岁儿童临床疟疾风险降低了31%。为了在疫苗研发和测试的关键路径上取得进展，以便在疟疾控制项目中实施新疫苗，我们在EPI计划的同时开展了一项SPf66的随机双盲安慰剂对照疗效试验。该试验期间对安全性和反应原性的监测包括对98名婴儿进行详细的临床和实验室评估，以及对所有1207名接种疫苗儿童在接种后1小时内的不良反应评估。监测系统对门诊就诊情况、住院情况和社区内的死亡事件进行了监测。与安慰剂相比，在接受SPf66的人群中未更频繁地检测到严重不良反应。对合成疫苗在非常年幼婴儿中的首次评估提供了良好安全性的证据。
