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.
OBJECTIVE
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.


METHODS
Double-blind, randomized, placebo controlled trial.


METHODS
The trial was conducted in the clinical trial ward of the Infectious Diseases Hospital in Kolkata, India.


METHODS
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.


METHODS
Participants were randomized to receive either the bivalent killed whole cell oral cholera vaccine or placebo (killed oral Escherichia coli K12).


METHODS
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.


BACKGROUND
ClinicalTrials.gov NCT00119197.
Society for Applied Studies, Kolkata, India.
Dilip
D
Mahalanabis
Anna Lena
AL
Lopez
Dipika
D
Sur
Jacqueline
J
Deen
Byomkesh
B
Manna
Suman
S
Kanungo
Lorenz
L
von Seidlein
Rodney
R
Carbis
Seung Hyun
SH
Han
Seong Hye
SH
Shin
Stephen
S
Attridge
Raman
R
Rao
Jan
J
Holmgren
John
J
Clemens
Sujit K
SK
Bhattacharya
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D002771:Cholera / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage* / Q000276:immunology; D004311:Double-Blind Method; D019353:Endemic Diseases / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D008297:Male; D017063:Outcome Assessment, Health Care; D010919:Placebos; D018401:Sample Size
D022121:Cholera Vaccines; D010919:Placebos