Taylor D N, Cárdenas V, Sanchez J L, Bégué R E, Gilman R, Bautista C, Perez J, Puga R, Gaillour A, Meza R, Echeverria P, Sadoff J
Dept. of Enteric Infections, Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Washington, DC 20307-5100, USA.
J Infect Dis. 2000 May;181(5):1667-73. doi: 10.1086/315462. Epub 2000 May 15.
The protective efficacy of an oral inactivated whole cell Vibrio cholerae plus recombinant B subunit cholera vaccine was determined against El Tor cholera among Peruvian children and adults (2-65 years old) in a randomized, double-blind manner. Study subjects received 2 doses of vaccine or placebo 2 weeks apart, followed by a booster dose 10 months later. Surveillance for cholera was performed actively, with 2 visits per week to each household, and passively, at a local hospital. Stool samples were collected during diarrhea episodes and were cultured for V. cholerae. A total of 17,799 persons received 2 doses of vaccine or placebo, and 14,997 of these persons received the booster dose. After 2 doses (first surveillance period), V. cholerae biotype O1 was isolated from 17 vaccinees and 16 placebo recipients, demonstrating vaccine efficacy (VE) of -4%. After 3 doses (second surveillance period), V. cholerae O1 was isolated from 13 vaccinees and 32 placebo recipients, demonstrating VE of 61% (95% confidence interval ¿CI, 28%-79%). In the second surveillance period, the VE for illness requiring hospitalization was 82% (95% CI, 27%-96%). VE was also higher for persons >15 years old (VE, 72%; 95% CI, 28%-89%).
采用随机、双盲方式，在秘鲁2至65岁儿童和成人中，测定口服灭活全细胞霍乱弧菌加重组B亚单位霍乱疫苗对埃尔托型霍乱的保护效力。研究对象每隔2周接受2剂疫苗或安慰剂，10个月后接受加强剂量。对霍乱进行主动监测，每周对每户进行2次访视，同时在当地医院进行被动监测。腹泻发作期间采集粪便样本，培养霍乱弧菌。共有17799人接受2剂疫苗或安慰剂，其中14997人接受了加强剂量。2剂后（第一个监测期），从17名疫苗接种者和16名安慰剂接受者中分离出霍乱弧菌生物型O1，疫苗效力（VE）为-4%。3剂后（第二个监测期），从13名疫苗接种者和32名安慰剂接受者中分离出霍乱弧菌O1，疫苗效力为61%（95%置信区间[CI]，28%-79%）。在第二个监测期，需要住院治疗的疾病的疫苗效力为82%（95%CI，27%-96%）。15岁以上人群的疫苗效力也更高（疫苗效力，72%；95%CI，28%-89%）。
