Randomized placebo controlled human volunteer trial of a live oral cholera vaccine VA1.3 for safety and immune response

被引：21

作者：

Mahalanabis, D. ^{[1
]}

Ramamurthy, T. ^{[2
]}

Nair, G. B. ^{[2
]}

Ghosh, A. ^{[2
,3
]}

Shaikh, S. ^{[1
]}

Sen, B. ^{[1
]}

Thungapathra, M. ^{[3
]}

Ghosh, R. K. ^{[4
]}

Pazhani, G. P. ^{[2
]}

Nandy, R. K. ^{[2
]}

Jana, S. ^{[5
]}

Bhattacharya, S. K. ^{[2
]}

机构：

[1] Soc Appl Studies, Kolkata 700064, W Bengal, India

[2] Natl Inst Cholera & Enter Dis, Kolkata 700010, India

[3] Inst Microbial Technol, Chandigarh, India

[4] Indian Inst Chem Biol, Kolkata 700010, India

[5] ID & BG Hosp, Kolkata 700010, India

来源：

VACCINE | 2009年 / 27卷 / 35期

关键词：

Live oral cholera vaccine; Human volunteer trial; ctxB gene insertion; ABO BLOOD-GROUPS; VIBRIO-CHOLERAE; CVD; 103-HGR; FIELD-TRIAL; ANTIBODY TITRE; ENDEMIC AREA; IMMUNOGENICITY; BANGLADESH; TOR; O1;

D O I：

10.1016/j.vaccine.2009.05.065

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

A live oral cholera vaccine developed from a non-toxigenic Vibrio cholerae O1 El Tor strain VA1.3 was tested in a double-blind randomized placebo controlled study for safety and immunogenicity in 304 men aged between 16 and 50 years from Kolkata, India. A dose of 5 x 10(9) CFU (n = 186) or a placebo (n = 116) containing the diluent buffer was administered. The vaccine did not elicit adverse events except in two vaccine recipients with mild diarrhoea and vomiting. None excreted the vaccine strain. Vibriocidal antibody response developed in 105/186 (57%) and 5/116 (4%) in vaccine and placebo recipients, respectively. In a subgroup, anti-CT antibody rose(>= 2-folds) in 23/30 (77%) and 6/19 (32%) in vaccine and placebo recipients, respectively. These studies demonstrate that VA1.3 at a dose of 5 x 10(9) is safe and immunogenic in adults from a cholera endemic region. (C) 2009 Elsevier Ltd. All rights reserved.

引用

页码：4850 / 4856

页数：7

共 33 条

[1] ABO BLOOD-GROUPS AND CHOLERA [J].