Document Detail


A cluster-randomized effectiveness trial of Vi typhoid vaccine in India.
MedLine Citation:
PMID:  19625715     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Typhoid fever remains an important cause of illness and death in the developing world. Uncertainties about the protective effect of Vi polysaccharide vaccine in children under the age of 5 years and about the vaccine's effect under programmatic conditions have inhibited its use in developing countries. METHODS: We conducted a phase 4 effectiveness trial in which slum-dwelling residents of Kolkata, India, who were 2 years of age or older were randomly assigned to receive a single dose of either Vi vaccine or inactivated hepatitis A vaccine, according to geographic clusters, with 40 clusters in each study group. The subjects were then followed for 2 years. RESULTS: A total of 37,673 subjects received a dose of a study vaccine. The mean rate of vaccine coverage was 61% for the Vi vaccine clusters and 60% for the hepatitis A vaccine clusters. Typhoid fever was diagnosed in 96 subjects in the hepatitis A vaccine group, as compared with 34 in the Vi vaccine group, with no subject having more than one episode. The level of protective effectiveness for the Vi vaccine was 61% (95% confidence interval [CI], 41 to 75; P<0.001 for the comparison with the hepatitis A vaccine group). Children who were vaccinated between the ages of 2 and 5 years had a level of protection of 80% (95% CI, 53 to 91). Among unvaccinated members of the Vi vaccine clusters, the level of protection was 44% (95% CI, 2 to 69). The overall level of protection among all residents of Vi vaccine clusters was 57% (95% CI, 37 to 71). No serious adverse events that were attributed to either vaccine were observed during the month after vaccination. CONCLUSIONS: The Vi vaccine was effective in young children and protected unvaccinated neighbors of Vi vaccinees. The potential for combined direct and indirect protection by Vi vaccine should be considered in future deliberations about introducing this vaccine in areas where typhoid fever is endemic. (ClinicalTrials.gov number, NCT00125008.)
Authors:
Dipika Sur; R Leon Ochiai; Sujit K Bhattacharya; Nirmal K Ganguly; Mohammad Ali; Byomkesh Manna; Shanta Dutta; Allan Donner; Suman Kanungo; Jin Kyung Park; Mahesh K Puri; Deok Ryun Kim; Dharitri Dutta; Barnali Bhaduri; Camilo J Acosta; John D Clemens
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Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  361     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2009 Jul 
Date Detail:
Created Date:  2009-07-23     Completed Date:  2009-07-29     Revised Date:  2010-10-07    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  335-44     Citation Subset:  AIM; IM    
Copyright Information:
2009 Massachusetts Medical Society
Affiliation:
National Institute of Cholera and Enteric Diseases, Kolkata, India.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00125008
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Antibodies, Bacterial / blood
Child
Child, Preschool
Developing Countries
Hepatitis A Vaccines / adverse effects
Humans
Immunoglobulin G / blood
India
Paratyphoid Fever / epidemiology
Polysaccharides, Bacterial / adverse effects,  immunology*
Population Surveillance
Salmonella typhi / immunology
Treatment Outcome
Typhoid Fever / epidemiology,  immunology,  prevention & control*
Typhoid-Paratyphoid Vaccines / adverse effects,  immunology*
Chemical
Reg. No./Substance:
0/Antibodies, Bacterial; 0/Hepatitis A Vaccines; 0/Immunoglobulin G; 0/Polysaccharides, Bacterial; 0/Typhoid-Paratyphoid Vaccines; 0/Vi polysaccharide vaccine, typhoid
Comments/Corrections
Comment In:
N Engl J Med. 2009 Jul 23;361(4):403-5   [PMID:  19625721 ]
N Engl J Med. 2009 Nov 26;361(22):2191-2; author reply 2192-3   [PMID:  19950412 ]
N Engl J Med. 2009 Nov 26;361(22):2191; author reply 2192-3   [PMID:  19940305 ]
Natl Med J India. 2010 Mar-Apr;23(2):90-1   [PMID:  20925206 ]

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