5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: A cluster-randomised, double-blind, placebo-controlled trial

Sujit K. Bhattacharya, Dipika Sur, Mohammad Ali, Suman Kanungo, Young Ae You, Byomkesh Manna, Binod Sah, Swapan K. Niyogi, Jin Kyung Park, Banwarilal Sarkar, Mahesh K. Puri, Deok Ryun Kim, Jacqueline L. Deen, Jan Holmgren, Rodney Carbis, Mandeep Singh Dhingra, Allan Donner, G. Balakrish Nair, Anna Lena Lopez, Thomas F. WierzbaJohn D. Clemens

Research output: Contribution to journalArticle

Abstract

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

Original languageEnglish (US)
Pages (from-to)1050-1056
Number of pages7
JournalLancet Infectious Diseases
Volume13
Issue number12
DOIs
StatePublished - Dec 2013

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Cholera Vaccines
India
Cholera
Vaccines
Placebos
Diarrhea
Vibrio cholerae O1
Poverty Areas
Escherichia coli K12
Health Facilities
Incidence
Random Allocation
Therapeutics
Randomized Controlled Trials
Hot Temperature
Delivery of Health Care
Safety
Population

ASJC Scopus subject areas

  • Infectious Diseases

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5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India : A cluster-randomised, double-blind, placebo-controlled trial. / Bhattacharya, Sujit K.; Sur, Dipika; Ali, Mohammad; Kanungo, Suman; You, Young Ae; Manna, Byomkesh; Sah, Binod; Niyogi, Swapan K.; Park, Jin Kyung; Sarkar, Banwarilal; Puri, Mahesh K.; Kim, Deok Ryun; Deen, Jacqueline L.; Holmgren, Jan; Carbis, Rodney; Dhingra, Mandeep Singh; Donner, Allan; Nair, G. Balakrish; Lopez, Anna Lena; Wierzba, Thomas F.; Clemens, John D.

In: Lancet Infectious Diseases, Vol. 13, No. 12, 12.2013, p. 1050-1056.

Research output: Contribution to journalArticle

Bhattacharya, SK, Sur, D, Ali, M, Kanungo, S, You, YA, Manna, B, Sah, B, Niyogi, SK, Park, JK, Sarkar, B, Puri, MK, Kim, DR, Deen, JL, Holmgren, J, Carbis, R, Dhingra, MS, Donner, A, Nair, GB, Lopez, AL, Wierzba, TF & Clemens, JD 2013, '5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: A cluster-randomised, double-blind, placebo-controlled trial', Lancet Infectious Diseases, vol. 13, no. 12, pp. 1050-1056. https://doi.org/10.1016/S1473-3099(13)70273-1
Bhattacharya, Sujit K. ; Sur, Dipika ; Ali, Mohammad ; Kanungo, Suman ; You, Young Ae ; Manna, Byomkesh ; Sah, Binod ; Niyogi, Swapan K. ; Park, Jin Kyung ; Sarkar, Banwarilal ; Puri, Mahesh K. ; Kim, Deok Ryun ; Deen, Jacqueline L. ; Holmgren, Jan ; Carbis, Rodney ; Dhingra, Mandeep Singh ; Donner, Allan ; Nair, G. Balakrish ; Lopez, Anna Lena ; Wierzba, Thomas F. ; Clemens, John D. / 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India : A cluster-randomised, double-blind, placebo-controlled trial. In: Lancet Infectious Diseases. 2013 ; Vol. 13, No. 12. pp. 1050-1056.
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abstract = "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",
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T1 - 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India

T2 - A cluster-randomised, double-blind, placebo-controlled trial

AU - Bhattacharya, Sujit K.

AU - Sur, Dipika

AU - Ali, Mohammad

AU - Kanungo, Suman

AU - You, Young Ae

AU - Manna, Byomkesh

AU - Sah, Binod

AU - Niyogi, Swapan K.

AU - Park, Jin Kyung

AU - Sarkar, Banwarilal

AU - Puri, Mahesh K.

AU - Kim, Deok Ryun

AU - Deen, Jacqueline L.

AU - Holmgren, Jan

AU - Carbis, Rodney

AU - Dhingra, Mandeep Singh

AU - Donner, Allan

AU - Nair, G. Balakrish

AU - Lopez, Anna Lena

AU - Wierzba, Thomas F.

AU - Clemens, John D.

PY - 2013/12

Y1 - 2013/12

N2 - 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

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