PROTECTIVE EFFICACY IN HUMANS OF KILLED WHOLE-VIBRIO ORAL CHOLERA VACCINE WITH AND WITHOUT THE B-SUBUNIT OF CHOLERA-TOXIN
PROTECTIVE EFFICACY IN HUMANS OF KILLED WHOLE-VIBRIO ORAL CHOLERA VACCINE WITH AND WITHOUT THE B-SUBUNIT OF CHOLERA-TOXIN
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DOI：
10.1128/iai.55.5.1116-1120.1987
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发表时间：
1987-05-01
影响因子：
3.1
通讯作者：
HOLMGREN, J
中科院分区：
文献类型：
--
作者：
BLACK, RE;LEVINE, MM;HOLMGREN, J
对霍乱的自然保护与局部肠道抗菌和抗毒抗体有关，它们似乎协同作用。虽然目前的肠外霍乱疫苗提供的保护不足，口服新疫苗有更多的希望。在成年志愿者中评价了单独或与霍乱毒素B亚单位一起给予的灭活霍乱弧菌。接种三剂疫苗的受试者和未接种疫苗的对照组摄入106株霍乱弧菌，以确定疫苗的保护效力。联合疫苗提供了64%的保护，而单独给予的全弧菌疫苗提供了56%的保护。此外，疫苗组的疾病比对照组的疾病轻，两种疫苗都能完全保护人们免受更严重的疾病的侵害。在近90%的对照组中，这种对引起霍乱的霍乱弧菌剂量的实质性保护水平表明，如果给予流行地区的人口，这些疫苗可能提供至少同样高的保护水平。事实上，孟加拉国正在进行一项田间效力试验，初步数据表明，灭活全弧菌加B亚单位疫苗的保护效力为85%，与志愿者中测试的效力相似，单独灭活全弧菌疫苗的效力为58%。因此，在人类志愿者中的研究成功地预测了霍乱流行地区疫苗提供的实质性保护。
Natural protection from cholera is associated with local intestinal antibacterial and antitoxic antibodies, which appear to act synergistically. Although current parenteral cholera vaccines offer insufficient protection, new vaccines administered orally have more promise. Killed Vibrio cholerae, alone or given with the B subunit of cholera toxin, was evaluated in adult volunteers. Vaccinees, who received three doses of either vaccine, and unvaccinated controls ingested 106 V. cholerae organisms to determine the protective efficacy of the vaccines. The combination vaccine provided 64% protection, and the whole vibrio vaccine given alone provided 56% protection. In addition, illnesses in vaccines were milder than those in controls, and both vaccines gave complete protection against more severe disease. This substantial level of protection against a dose of V. cholerae that caused cholera in nearly 90% of controls suggests that these vaccines might provide at least as high a level of protection if given to the population of an endemic area. Indeed, a field efficacy trial is underway in Bangladesh, and preliminary data indicate a protective efficacy of 85% for a killed whole vibrio plus B subunit vaccine similar to that tested in volunteers and an efficacy of 58% for the killed whole vibrio vaccine alone. Thus, the studies in human volunteers were successful in predicting the substantial protection afforded by the vaccines in a cholera endemic area.