Graves P, Gelband H
Centers for Diseases Control and Prevention, Division of Parasitic Diseases, Mailstop F42, Building 102, Room 2113, 4770 Burford Highway NE, Atlanta, GA 30306, USA.
Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005966. doi: 10.1002/14651858.CD005966.
A malaria vaccine is badly needed. SPf66 was one of the earliest vaccines developed. It is a synthetic peptide vaccine containing antigens from the blood stages of malaria linked together with an antigen from the sporozoite stage, and is targeted mainly against the blood (asexual) stages.
To assess the effect of SPf66 malaria vaccines against Plasmodium falciparum, P. vivax, P. malariae, and P. ovale in preventing infection, disease, and death.
We searched the Cochrane Infectious Diseases Group Specialized Register (September 2005), CENTRAL (The Cochrane Library 2005, Issue 3), MEDLINE (1966 to September 2005), EMBASE (1980 to September 2005), LILACS (1982 to September 2005), Science Citation Index (1981 to September 2005), and reference lists of articles. We also contacted organizations and researchers in the field.
Randomized and quasi-randomized controlled trials comparing SPf66 vaccine with placebo or routine antimalarial control measures in people of any age receiving an artificial challenge or natural exposure to malaria infection (any species).
Two people independently assessed trial quality and extracted data, including adverse events. Results were expressed as relative risks (RR) with 95% confidence intervals (CI).
Ten efficacy trials of SPf66 involving 9698 participants were included. Results with SPf66 in reducing new episodes of P. falciparum malaria were heterogeneous: it was not effective in four African trials (RR 0.98, 95% CI 0.90 to 1.07; 2371 participants) or in one Asian trial (RR 1.06, 95% CI 0.90 to 1.25; 1221 participants). In four trials in South America the number of first attacks with P. falciparum was reduced by 28% (RR 0.72, 95% CI 0.63 to 0.82; 3807 participants). It did not reduce episodes of P. vivax malaria or admission to hospital with severe malaria. Trials have not indicated any serious adverse events with SPf66 vaccine.
AUTHORS' CONCLUSIONS: There is no evidence for protection by SPf66 vaccines against P. falciparum in Africa. There is a modest reduction in attacks of P. falciparum malaria following vaccination with SPf66 in South America. There is no justification for further trials of SPf66 in its current formulation. Further research with SPf66 vaccines in South America or with new formulations of SPf66 may be justified.
疟疾疫苗的需求极为迫切。SPf66是最早研发的疫苗之一。它是一种合成肽疫苗，包含来自疟疾血液阶段的抗原与来自子孢子阶段的一种抗原连接在一起，主要针对血液（无性）阶段。
评估SPf66疟疾疫苗对恶性疟原虫、间日疟原虫、三日疟原虫和卵形疟原虫在预防感染、疾病和死亡方面的效果。
我们检索了Cochrane传染病组专业注册库（2005年9月）、CENTRAL（Cochrane图书馆2005年第3期）、MEDLINE（1966年至2005年9月）、EMBASE（1980年至2005年9月）、LILACS（1982年至2005年9月）、科学引文索引（1981年至2005年9月）以及文章的参考文献列表。我们还联系了该领域的组织和研究人员。
将SPf66疫苗与安慰剂或常规抗疟对照措施进行比较的随机和半随机对照试验，受试对象为任何年龄且接受人工感染或自然感染疟疾（任何种类）的人群。
两人独立评估试验质量并提取数据，包括不良事件。结果以相对风险（RR）及95%置信区间（CI）表示。
纳入了10项关于SPf66的疗效试验，涉及9698名参与者。SPf66在减少恶性疟原虫疟疾新发病例方面的结果存在异质性：在四项非洲试验中无效（RR 0.98，95% CI 0.90至1.07；2371名参与者），在一项亚洲试验中也无效（RR 1.06，95% CI 0.90至1.25；1221名参与者）。在南美洲的四项试验中，恶性疟原虫首次发作的次数减少了28%（RR 0.72，95% CI 0.63至0.82；3807名参与者）。它并未减少间日疟原虫疟疾的发作次数或因严重疟疾住院的人数。试验未表明SPf66疫苗有任何严重不良事件。
没有证据表明SPf66疫苗在非洲能预防恶性疟原虫感染。在南美洲，接种SPf66疫苗后恶性疟原虫疟疾发作次数有一定程度的减少。没有理由对目前配方的SPf66进行进一步试验。在南美洲对SPf66疫苗或其新配方进行进一步研究可能是合理的。
