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

doi:10.1016/s1473-3099(13)70273-1

Cited by 213 publications

(212 citation statements)

References 19 publications

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“…[27][28][29] Shanchol has conferred 67% protection in a double blind randomized placebo controlled trial in more than 67,000 children and adults in Kolkata, India. 30 However, levels of protection were not uniform across all age groups. Young children aged one to 5 y, were significantly less protected with a cumulative efficacy of 42% over 5 y.…”

Section: Modified Killed Whole Cell Only Vaccinesmentioning

confidence: 98%

Achievements and challenges for the use of killed oral cholera vaccines in the global stockpile era

Desai

Pezzoli

Alberti

et al. 2016

Human Vaccines & Immunotherapeutics

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Cholera remains an important but neglected public health threat, affecting the health of the poorest populations and imposing substantial costs on public health systems. Cholera can be eliminated where access to clean water, sanitation, and satisfactory hygiene practices are sustained, but major improvements in infrastructure continue to be a distant goal. New developments and trends of cholera disease burden, the creation of affordable oral cholera vaccines (OCVs) for use in developing countries, as well as recent evidence of vaccination impact has created an increased demand for cholera vaccines. The global OCV stockpile was established in 2013 and with support from Gavi, has assisted in achieving rapid access to vaccine in emergencies. Recent WHO prequalification of a second affordable OCV supports the stockpile goals of increased availability and distribution to affected populations. It serves as an essential step toward an integrated cholera control and prevention strategy in emergency and endemic settings.

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Section: Modified Killed Whole Cell Only Vaccinesmentioning

confidence: 98%

Achievements and challenges for the use of killed oral cholera vaccines in the global stockpile era

Desai

Pezzoli

Alberti

et al. 2016

Human Vaccines & Immunotherapeutics

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“…Using the same method, we calculated the expected proportion of patients with cholera who were vaccinated to be 8%, not 36% as they calculated, compared with the 6% observed, suggesting that chronic HCV infection treated with both interferon-based 4 and interferonfree 5 direct-acting antiviral regimens. In the C-SWIFT study, 5 which assessed the efficacy of 6 weeks of grazoprevir/ elbasvir plus sofosbuvir in patients with non-cirrhotic HCV genotype 1 infection, the sustained virological response rate 12 weeks after the end of treatment was 69% (nine of 13) in patients with baseline HCV RNA greater than 2 000 000 IU/mL, and 100% (17 of 17) in those with baseline HCV RNA 2 000 000 IU/mL or lower.…”

Section: Authors' Replymentioning

confidence: 99%

“…[2][3][4] Estimates of short-term efficacy of one and two doses of OCV in south Asia are similar, suggesting that, at least in the short-term, one dose might provide similar protection to two doses. 3,5 Single-dose campaigns allow the vaccinated population to double, with fewer doses, which might improve the effect of reactive campaigns through direct and herd protection. 6 Considering the best evidence available, the South Sudan Ministry of Health made the difficult decision to use the small amount of vaccine available in a single-dose campaign to cover more people.…”

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confidence: 99%

“…3 Efficacy of onedose OCV was estimated to be about 40% (95% CI 11-60) in a double-blind placebo-controlled clinical trial. 4 Using the WHO screening method 5 with provided data, we calculated that 36% of cholera cases were expected to occur in vaccinated individuals in Juba. The observed proportion was only 6%, 3 which suggests biases that the authors could not address despite their efforts to do so.…”

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confidence: 99%

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Vaccination against cholera in Juba – Authors' reply

Ciglenečki

Azman

Rumunu³

et al. 2017

The Lancet Infectious Diseases

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“…Since the 1980s, oral cholera vaccines (OCVs) comprising either killed or live cells have been used. Of these, the following oral vaccines have been subjected to large-scale field trials: killed whole V. cholerae O1 cells (WC), WC with the B subunit of CT (CTB) isolated from culture supernatant (WC-CTB), WC with the CTB prepared by recombinant DNA technology (WC-rCTB), WC with killed V. cholerae O139 cells and live attenuated V. cholerae O1 cells (23)(24)(25)(26)(27)(28)(29)(30). Only two vaccines, WC-rCTB and WC with V. cholerae O139, sold commercially as Dukoral and Shanchol, respectively, are currently available and have been prequalified by the World Health Organization (WHO) (31,32).…”

Section: Cholera Vaccinesmentioning

confidence: 99%

Critical Analysis of Compositions and Protective Efficacies of Oral Killed Cholera Vaccines

Kabir

2014

Clin. Vaccine Immunol.

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Two cholera vaccines, sold as Shanchol and Dukoral, are currently available. This review presents a critical analysis of the protective efficacies of these vaccines. Children under 5 years of age are very vulnerable to cholera and account for the highest incidence of cholera cases and more than half of the resulting deaths. Both Shanchol and Dukoral are two-spaced-dose oral vaccines comprising large numbers of killed cholera bacteria. The former contains Vibrio cholerae O1 and O139 cells, and the latter contains V. cholerae O1 cells with the recombinant B subunit of cholera toxin. In a field trial in Kolkata (India), Shanchol, the preferred vaccine, protected 45% of the test subjects in all of the age groups and only 17% of the children under 5 years of age during the first year of surveillance. In a field trial in Peru, two spaced doses of Dukoral offered negative protection in children under 5 years of age and little protection (15%) in vaccinees over 6 years of age during the first year of surveillance. Little is known about Dukoral's long-term protective efficacy. Both of these vaccines have questionable compositions, using V. cholerae O1 strains isolated in 1947 that have been inactivated by heat and formalin treatments that may denature protein. Immunological studies revealed Dukoral's reduced and short-lived efficacy, as measured by several immunological endpoints. Various factors, such as the necessity for multiple doses, poor protection of children under 5 years of age, the requirement of a cold supply chain, production costs, and complex logistics of vaccine delivery, greatly reduce the suitability of either of these vaccines for endemic or epidemic cholera control in resource-poor settings.

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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

Cited by 213 publications

References 19 publications

Achievements and challenges for the use of killed oral cholera vaccines in the global stockpile era

Achievements and challenges for the use of killed oral cholera vaccines in the global stockpile era

Vaccination against cholera in Juba – Authors' reply

Critical Analysis of Compositions and Protective Efficacies of Oral Killed Cholera Vaccines

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