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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: A cluster-randomised, double-blind, placebo-controlled trial
The Lancet Infectious Diseases, Volume 13, No. 12, Year 2013
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Description
Background: Efficacy and safety of a two-dose regimen of bivalent killed whole-cell oral cholera vaccine (Shantha Biotechnics, Hyderabad, India) to 3 years is established, but long-term efficacy is not. We aimed to assess protective efficacy up to 5 years in a slum area of Kolkata, India. Methods: In our double-blind, cluster-randomised, placebo-controlled trial, we assessed incidence of cholera in non-pregnant individuals older than 1 year residing in 3933 dwellings (clusters) in Kolkata, India. We randomly allocated participants, by dwelling, to receive two oral doses of modified killed bivalent whole-cell cholera vaccine or heat-killed Escherichia coli K12 placebo, 14 days apart. Randomisation was done by use of a computer-generated sequence in blocks of four. The primary endpoint was prevention of episodes of culture-confirmed Vibrio cholerae O1 diarrhoea severe enough for patients to seek treatment in a health-care facility. We identified culture-confirmed cholera cases among participants seeking treatment for diarrhoea at a study clinic or government hospital between 14 days and 1825 days after receipt of the second dose. We assessed vaccine protection in a per-protocol population of participants who had completely ingested two doses of assigned study treatment. Findings: 69 of 31932 recipients of vaccine and 219 of 34968 recipients of placebo developed cholera during 5 year follow-up (incidence 2·2 per 1000 in the vaccine group and 6·3 per 1000 in the placebo group). Cumulative protective efficacy of the vaccine at 5 years was 65% (95% CI 52-74; p<0·0001), and point estimates by year of follow-up suggested no evidence of decline in protective efficacy. Interpretation: Sustained protection for 5 years at the level we reported has not been noted previously with other oral cholera vaccines. Established long-term efficacy of this vaccine could assist policy makers formulate rational vaccination strategies to reduce overall cholera burden in endemic settings. Funding: Bill & Melinda Gates Foundation and the governments of South Korea and Sweden. © 2013 Elsevier Ltd.
Authors & Co-Authors
Bhattacharya, Sujit Kumar
India, Kolkata
National Institute of Cholera and Enteric Diseases India
India, New Delhi
Indian Council of Medical Research
Sur, Deepika
India, Kolkata
National Institute of Cholera and Enteric Diseases India
Ali, Mohammad M.
South Korea, Seoul
International Vaccine Institute, Seoul
Kanungo, Suman
India, Kolkata
National Institute of Cholera and Enteric Diseases India
You, Young-ae
South Korea, Seoul
International Vaccine Institute, Seoul
Manna, Byomkesh
India, Kolkata
National Institute of Cholera and Enteric Diseases India
Sah, Binod K.
South Korea, Seoul
International Vaccine Institute, Seoul
Niyogi, Swapan Kumar
India, Kolkata
National Institute of Cholera and Enteric Diseases India
Park, Jinkyung Kyoung
South Korea, Seoul
International Vaccine Institute, Seoul
Sarkar, Banawarilal
India, Kolkata
National Institute of Cholera and Enteric Diseases India
Puri, Mahesh K.
South Korea, Seoul
International Vaccine Institute, Seoul
Kim, Deokryun
South Korea, Seoul
International Vaccine Institute, Seoul
Deen, Jacqueline L.
Australia, Darwin
Menzies School of Health Research
Holmgren, Jan R.
Sweden, Gothenburg
Göteborgs Universitet
Donner, Allan P.
Canada, London
Western University
Lopez, Anna Lena
South Korea, Seoul
International Vaccine Institute, Seoul
Philippines, Manila
National Institutes of Health, University of the Philippines Manila
Wierzba, Thomas F.
South Korea, Seoul
International Vaccine Institute, Seoul
Clemens, John David
South Korea, Seoul
International Vaccine Institute, Seoul
United States, Los Angeles
University of California, Los Angeles
Bangladesh, Dhaka
International Centre for Diarrhoeal Disease Research Bangladesh
Statistics
Citations: 208
Authors: 18
Affiliations: 9
Identifiers
Doi:
10.1016/S1473-3099(13)70273-1
ISSN:
14744457
Research Areas
Disability
Health System And Policy
Infectious Diseases
Study Design
Cross Sectional Study
Cohort Study