Alonso P L, Smith T A, Armstrong-Schellenberg J R, Kitua A Y, Masanja H, Hayes R, Hurt N, Font F, Menendez C, Kilama W L, Tanner M
Unidad de Epidemiologia y Bioestadistica, Hospital Clinic, Barcelona, Spain.
J Infect Dis. 1996 Aug;174(2):367-72. doi: 10.1093/infdis/174.2.367.
The SPf66 synthetic vaccine is safe and partly efficacious against Plasmodium falciparum malaria among children 1-5 years old. The estimated vaccine efficacy [VE] for all clinical episodes over a period of 18 months after the third dose is 25% (95% confidence interval [CI], 1%-44%; P = .044). The observed temporal variations in efficacy could have been due to chance (likelihood ratio chi 2 = 13.8, 8 df; P = .086). Efficacy against clinical malaria did not vary significantly with age (chi 2 = 1.07, 4 df; P = .90). Overall parasite density was 21% lower in vaccine recipients than in the placebo group (95% CI, 0%-38%; P = .044). Further development of SPf66 may require trials to evaluate safety, immunogenicity, and efficacy when administered in the first year of life, together with other vaccines contained in the Expanded Programme of Immunization schedule.
SPf66合成疫苗对1至5岁儿童的恶性疟原虫疟疾是安全且部分有效的。第三剂接种后18个月内所有临床发作的估计疫苗效力（VE）为25%（95%置信区间[CI]，1%-44%；P = 0.044）。观察到的效力随时间的变化可能是由于偶然因素（似然比卡方 = 13.8，8自由度；P = 0.0 86）。抗临床疟疾的效力在不同年龄之间无显著差异（卡方 = 1.07，4自由度；P = 0.90）。疫苗接种者的总体寄生虫密度比安慰剂组低21%（95%CI，0%-38%；P = 0.044）。SPf66的进一步研发可能需要进行试验，以评估其在生命第一年与扩大免疫规划时间表中的其他疫苗同时接种时的安全性、免疫原性和效力。
