Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh.
Randomized, controlled study of the safety and immunogenicity of Peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh.
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对 Peru-15（一种霍乱口服减毒候选疫苗）在孟加拉国成年志愿者中进行的安全性和免疫原性的随机对照研究。
DOI：
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发表时间：
2005
影响因子：
6.4
通讯作者：
D. Sack
中科院分区：
文献类型：
--
作者：
F. Qadri;M. Chowdhury;S. Faruque;M. Salam;T. Ahmed;Y. Begum;A. Saha;M. S. Alam;K. Zaman;L. Seidlein;E. Park;K. Killeen;J. Mekalanos;J. Clemens;D. Sack
背景
在孟加拉国成年人的第1期（住院）和第2期（门诊）研究中，研究了口服霍乱弧菌O 1 El Tor活疫苗候选疫苗秘鲁-15的安全性、免疫原性和排泄。方法。本研究在成人中进行，采用双盲、随机、安慰剂对照设计。在标准碳酸氢盐和抗坏血酸缓冲液中给予单剂量的秘鲁-15（约2 × 108 cfu）或安慰剂（仅缓冲液）。在住院或门诊阶段，研究治疗未在志愿者中引起任何重大不良事件，也未报告腹泻。仅从1名志愿者的粪便中分离出霍乱弧菌，发现其与疫苗株在遗传上相同。在40名疫苗接种者中的30名（75%）和30名安慰剂接种者中的3名（10%）中观察到杀弧菌抗体应答。大多数疫苗接种者均观察到外周血免疫球蛋白（IG）A和IgM抗体分泌细胞对脂多糖的反应（反应率，78%--88%）。在88%的疫苗接种者中观察到脂多糖特异性伊加抗体的血清转化。在所有的免疫学检测中，疫苗接种者的应答显著高于安慰剂接种者（P= 0.036至<0.001）。结果显示，霍乱毒素B亚单位的免疫应答较低。这种秘鲁-15候选疫苗的安全性和免疫原性表明，在霍乱流行的孟加拉国，未来的研究是有用的。
BACKGROUND
A live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults.METHODs. The study was conducted among adults, by use of a double-blind, randomized, placebo-controlled design. A single dose of Peru-15 (approximately 2 x 108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer.RESULTS. Study treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%--88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to <.001). A lower immunological response against cholera toxin B subunit was detected.CONCLUSIONS. The safety and immunogenicity of this Peru-15 vaccine candidate indicates the usefulness of future studies in Bangladesh, where cholera is endemic.
泰国士兵和平民CVD 103-HgR口服霍乱活疫苗不同免疫方案的安全性和免疫原性。
DOI：
10.1093/infdis/165.6.1042
发表时间：
1992
期刊：
The Journal of infectious diseases
影响因子：
--
作者：
Su-Arehawaratana,P;Singharaj,P;Taylor,DN;Hoge,C;Trofa,A;Kuvanont,K;Migasena,S;Pitisuttitham,P;Lim,YL;Losonsky,G
通讯作者：
Losonsky,G