在印度加尔各答霍乱流行地区对成人和儿童进行的二价灭活全细胞口服霍乱疫苗随机安慰剂对照试验。
A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India.
作者信息
Mahalanabis Dilip, Lopez Anna Lena, Sur Dipika, Deen Jacqueline, Manna Byomkesh, Kanungo Suman, von Seidlein Lorenz, Carbis Rodney, Han Seung Hyun, Shin Seong Hye, Attridge Stephen, Rao Raman, Holmgren Jan, Clemens John, Bhattacharya Sujit K
机构信息
Society for Applied Studies, Kolkata, India.
出版信息
PLoS One. 2008 Jun 4;3(6):e2323. doi: 10.1371/journal.pone.0002323.
OBJECTIVES
An effective vaccine against cholera has been used for public health purposes in Vietnam since the 1990s. This vaccine was reformulated to meet WHO requirements. We assessed the safety and immunogenicity of the reformulated bivalent (Vibrio cholerae 01 and 0139) killed whole cell oral vaccine in a cholera endemic area in Kolkata, India.
DESIGN
Double-blind, randomized, placebo controlled trial.
SETTING
The trial was conducted in the clinical trial ward of the Infectious Diseases Hospital in Kolkata, India.
PARTICIPANTS
The participants were 101 healthy adults (males and non-pregnant females) aged 18-40 years and 100 healthy children (males and non-pregnant females) aged 1-17 years.
INTERVENTIONS
Participants were randomized to receive either the bivalent killed whole cell oral cholera vaccine or placebo (killed oral Escherichia coli K12).
OUTCOME MEASURES
For safety: proportion of subjects with adverse events during the duration of study participation. For immunogenicity: Proportion of subjects who had a > or = 4-fold rise in serum vibriocidal antibody titers 14 days after the second dose of vaccine or placebo.
RESULTS
Adverse reactions were observed with similar frequency among vaccine and placebo recipients in both age groups. Among adults 4% of vaccine and 8% of placebo recipients and among children 4% of vaccine and 2% of placebo recipients had at least one adverse event within 28 days of the first dose of the vaccine. Following immunization, 53% of adult and 80% of children vaccinees showed a > or = 4 fold rise in serum V. cholerae O1 vibriocidal antibody titers. A less pronounced response to V. cholerae O139 vibriocidal antibody titers post-immunization was noted among vaccinees.
CONCLUSIONS
We found the vaccine to be safe and immunogenic in a cholera-endemic area in India.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00119197.
目的
自20世纪90年代以来，一种有效的霍乱疫苗已在越南用于公共卫生目的。该疫苗进行了重新配方以满足世界卫生组织的要求。我们在印度加尔各答的一个霍乱流行地区评估了重新配方的二价（霍乱弧菌O1和O139）全细胞口服灭活疫苗的安全性和免疫原性。
设计
双盲、随机、安慰剂对照试验。
地点
试验在印度加尔各答传染病医院的临床试验病房进行。
参与者
参与者为101名年龄在18至40岁的健康成年人（男性和非孕女性）以及100名年龄在1至17岁的健康儿童（男性和非孕女性）。
干预措施
参与者被随机分配接受二价全细胞口服霍乱灭活疫苗或安慰剂（口服灭活大肠杆菌K12）。
观察指标
安全性方面：研究参与期间出现不良事件的受试者比例。免疫原性方面：在接种第二剂疫苗或安慰剂14天后血清杀弧菌抗体滴度升高≥4倍的受试者比例。
结果
两个年龄组中，疫苗接种者和安慰剂接受者出现不良反应的频率相似。在成年人中，4%的疫苗接种者和8%的安慰剂接受者，在儿童中，4%的疫苗接种者和2%的安慰剂接受者在第一剂疫苗接种后28天内至少出现一次不良事件。免疫接种后，53%的成年疫苗接种者和80%的儿童疫苗接种者血清霍乱弧菌O1杀弧菌抗体滴度升高≥4倍。疫苗接种者中，免疫接种后对霍乱弧菌O139杀弧菌抗体滴度的反应不太明显。
结论
我们发现该疫苗在印度的一个霍乱流行地区是安全且具有免疫原性的。
试验注册
ClinicalTrials.gov NCT00119197
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