Graves P, Deeks J, Demicheli V, Pratt M, Jefferson T
Dept of Preventive Medicine & Biometrics, University of Colorado Health Sciences Center, Box C 245, 4200 E Ninth Ave, Denver, CO 80262, USA.
Cochrane Database Syst Rev. 2000(2):CD000974. doi: 10.1002/14651858.CD000974.
Oral cholera vaccines (either killed whole cell or live recombinant vaccines) are newer alternatives to the parenteral vaccines which have been thought to confer only moderate and short-term immunity.
The objective of this review was to assess the effect of cholera vaccines in preventing cases of cholera and preventing deaths.
We searched the Cochrane Infectious Diseases Group trials register, Medline, Embase and reference lists of articles. We handsearched the journal Vaccine, contacted researchers in the field and manufacturers.
Randomised and quasi-randomised studies comparing cholera vaccines (killed or live) with placebo, control vaccines or no intervention, or comparing types, doses or schedules of cholera vaccine. We included adults and children irrespective of immune status or special risk category.
Data extraction and assessment of trial quality was done independently by two reviewers.
Thirty-two trials were included. Seventeen efficacy trials of relatively good quality, testing parenteral and oral killed whole cell vaccines and involving over 2. 6 million adults, children and infants were included. Nineteen safety trials have been conducted for both types of killed whole cell vaccines and for live vaccines and have involved 11,459 people. For all types of vaccines compared to placebo, the relative risk of contracting cholera at 12 months was 0.49, 95% confidence interval 0. 41 to 0.59 (random effects model). This translates to an efficacy of 51%, 95% confidence interval 41% to 59%. Both parenteral and oral administration were relatively efficacious, but significant protection extended into the third year for oral killed whole cell vaccines. Children under 5 were only protected for up to a year, while older children or adults were protected for up to three years. Parenteral killed whole cell vaccines were associated with increased systemic and local adverse effects compared to placebo. Oral killed whole cell vaccines or oral live vaccines were not.
REVIEWER'S CONCLUSIONS: Cholera killed whole cell vaccines appear to be relatively effective and safe. Live oral recombinant vaccines appear to be safe, but efficacy data are not available. Protection against cholera appears to persist for up to two years following a single dose of vaccine, and for three to four years with an annual booster.
口服霍乱疫苗(全细胞灭活疫苗或活重组疫苗)是肠外疫苗的较新替代方案,肠外疫苗被认为只能提供中等程度的短期免疫力。
本综述的目的是评估霍乱疫苗在预防霍乱病例和预防死亡方面的效果。
我们检索了Cochrane传染病小组试验注册库、医学期刊数据库、荷兰医学文摘数据库以及文章的参考文献列表。我们还手工检索了《疫苗》杂志,联系了该领域的研究人员和制造商。
比较霍乱疫苗(灭活或活疫苗)与安慰剂、对照疫苗或无干预措施,或比较霍乱疫苗的类型、剂量或接种程序的随机和半随机研究。我们纳入了成人和儿童,无论其免疫状态或特殊风险类别如何。
由两名评审员独立进行数据提取和试验质量评估。
纳入了32项试验。其中包括17项质量相对较好的疗效试验,这些试验测试了肠外和口服全细胞灭活疫苗,涉及超过260万成人、儿童和婴儿。针对两种类型的全细胞灭活疫苗和活疫苗进行了19项安全性试验,涉及11459人。与安慰剂相比,所有类型疫苗在12个月时感染霍乱的相对风险为0.49,95%置信区间为0.41至0.59(随机效应模型)。这相当于有效率为51%,95%置信区间为41%至59%。肠外和口服给药都相对有效,但口服全细胞灭活疫苗的显著保护作用可延续至第三年。5岁以下儿童仅在长达一年的时间内受到保护,而年龄较大的儿童或成人则在长达三年的时间内受到保护。与安慰剂相比,肠外全细胞灭活疫苗会增加全身和局部不良反应。口服全细胞灭活疫苗或口服活疫苗则不会。
霍乱全细胞灭活疫苗似乎相对有效且安全。口服活重组疫苗似乎安全,但尚无疗效数据。单剂量疫苗接种后对霍乱的保护作用似乎可持续长达两年,每年加强接种则可持续三至四年。