Lucas Marcelino E S, Deen Jacqueline L, von Seidlein Lorenz, Wang Xuan-Yi, Ampuero Julia, Puri Mahesh, Ali Mohammad, Ansaruzzaman M, Amos Juvenaldo, Macuamule Arminda, Cavailler Philippe, Guerin Philippe J, Mahoudeau Claude, Kahozi-Sangwa Pierre, Chaignat Claire-Lise, Barreto Avertino, Songane Francisco F, Clemens John D
Ministry of Health, Maputo, Mozambique.
N Engl J Med. 2005 Feb 24;352(8):757-67. doi: 10.1056/NEJMoa043323.
New-generation, orally administered cholera vaccines offer the promise of improved control of cholera in sub-Saharan Africa. However, the high prevalence of human immunodeficiency virus (HIV) infection in many cholera-affected African populations has raised doubts about the level of protection possible with vaccination. We evaluated a mass immunization program with recombinant cholera-toxin B subunit, killed whole-cell (rBS-WC) oral cholera vaccine in Beira, Mozambique, a city where the seroprevalence of HIV is 20 to 30 percent.
From December 2003 to January 2004, we undertook mass immunization of nonpregnant persons at least two years of age, using a two-dose regimen of rBS-WC vaccine in Esturro, Beira (population 21,818). We then assessed vaccine protection in a case-control study during an outbreak of El Tor Ogawa cholera in Beira between January and May 2004. To estimate the level of vaccine protection, antecedent rates of vaccination were compared between persons with culture-confirmed cholera severe enough to have prompted them to seek treatment and age- and sex-matched neighborhood controls without treated diarrhea.
We assessed the effectiveness of the vaccine in 43 persons with cholera and 172 controls. Receipt of one or more doses of rBS-WC vaccine was associated with 78 percent protection (95 percent confidence interval, 39 to 92 percent; P=0.004). The vaccine was equally effective in children younger than five years of age and in older persons. A concurrently conducted case-control study designed to detect bias compared persons with treated, noncholeraic diarrhea and controls without diarrhea in the same population and found no protection associated with receipt of the rBS-WC vaccine.
The rBS-WC vaccine was highly effective against clinically significant cholera in an urban sub-Saharan African population with a high prevalence of HIV infection.
新一代口服霍乱疫苗有望改善撒哈拉以南非洲地区霍乱的防控情况。然而,许多受霍乱影响的非洲人群中人类免疫缺陷病毒(HIV)感染率很高,这引发了人们对疫苗所能提供的保护水平的质疑。我们在莫桑比克贝拉市评估了一项使用重组霍乱毒素B亚单位、全细胞灭活(rBS-WC)口服霍乱疫苗的大规模免疫计划,该市HIV血清阳性率为20%至30%。
2003年12月至2004年1月,我们在贝拉市埃斯图罗(人口21,818)对至少两岁的非孕妇进行了大规模免疫,采用两剂次rBS-WC疫苗接种方案。然后,在2004年1月至5月贝拉市埃尔托小川型霍乱疫情期间,我们在一项病例对照研究中评估了疫苗的保护效果。为了估计疫苗的保护水平,比较了霍乱确诊且病情严重到促使其寻求治疗的患者与年龄和性别匹配的无腹泻邻里对照者之前的疫苗接种率。
我们评估了43例霍乱患者和172例对照者的疫苗效果。接种一剂或多剂rBS-WC疫苗可提供78%的保护(95%置信区间,39%至92%;P = 0.004)。该疫苗在五岁以下儿童和老年人中同样有效。一项同时进行的旨在检测偏差的病例对照研究比较了同一人群中患有经治疗的非霍乱性腹泻的患者和无腹泻的对照者,发现接种rBS-WC疫苗与保护效果无关。
在HIV感染率很高的撒哈拉以南非洲城市人群中,rBS-WC疫苗对具有临床意义的霍乱具有高度有效性。