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5 year efficacy of ...
5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: A cluster-randomised, double-blind, placebo-controlled trial
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Bhattacharya, S. K. (author)
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Sur, D. (author)
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Ali, M. (author)
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Kanungo, S. (author)
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You, Y. A. (author)
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Manna, B. (author)
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Sah, B. (author)
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Niyogi, S. K. (author)
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Park, J. K. (author)
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Sarkar, B. (author)
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Puri, M. K. (author)
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Kim, D. R. (author)
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Deen, J. L. (author)
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- Holmgren, Jan, 1944 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för mikrobiologi och immunologi,Institute of Biomedicine, Department of Microbiology and Immunology
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Carbis, R. (author)
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Dhingra, M. S. (author)
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Donner, A. (author)
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Nair, G. B. (author)
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Lopez, A. L. (author)
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Wierzba, T. F. (author)
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Clemens, J. D. (author)
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(creator_code:org_t)
- 2013
- 2013
- English.
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In: Lancet. Infectious Diseases. - 1473-3099 .- 1474-4457. ; 13:12, s. 1050-1056
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Keyword
- bivalent killed whole cell oral cholera vaccine
- cholera vaccine
- inactivated vaccine
- placebo
- shanchol
- unclassified drug
- adolescent
- article
- child
- cholera
- controlled study
- double blind procedure
- drug efficacy
- Escherichia coli K 12
- follow up
- human
- incidence
- India
- infant
- infection rate
- infectious diarrhea
- major clinical study
- outcome assessment
- preschool child
- priority journal
- randomized controlled trial
- school child
- vaccination
- Administration
- Oral
- Child
- Preschool
- Cholera Vaccines
- Cluster Analysis
- Diarrhea
- Double-Blind Method
- Humans
- Placebos
- Vaccines
- Inactivated
- Vibrio cholerae O1
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Bhattacharya, S. ...
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Sur, D.
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Ali, M.
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Kanungo, S.
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You, Y. A.
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Manna, B.
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show more...
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Sah, B.
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Niyogi, S. K.
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Park, J. K.
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Sarkar, B.
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Puri, M. K.
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Kim, D. R.
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Deen, J. L.
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Holmgren, Jan, 1 ...
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Carbis, R.
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Dhingra, M. S.
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Donner, A.
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Nair, G. B.
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Lopez, A. L.
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Wierzba, T. F.
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Clemens, J. D.
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show less...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Infectious Medic ...
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Lancet. Infectio ...
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University of Gothenburg