A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines

Baik, Yeong Ok; Choi, Seo‐Hyun; Olveda, Remigio M.; Espos, Roberto A.; Ligsay, Antonio D.; Montellano, May; Yeam, Jong Sun; Yang, Jae Seung; Park, Ju Yeon; Kim, Deok Ryun; Desai, Sachin N.; Singh, Ajit Pal; Kim, Ick Young; Kim, Chan Wha; Park, Sue Nie

doi:10.1016/j.vaccine.2015.08.075

Cited by 61 publications

(58 citation statements)

References 11 publications

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“…Other national regulatory agencies have also recently used noninferiority of seroconversion of serum vibriocidal antibody to license Euvichol ™ , an inactivated V. cholerae vaccine closely It is evident that in all vaccine groups the peak GMT is observed 10 days after immunization and that the titers fall progressively thereafter through day 180 post-vaccination but remain significantly above baseline. The Day 180 GMT remained significantly elevated above baseline GMT in the challenge, 3-lot consistency and older subject (age 46-64 years) studies (p = 0.001, p < 0.0001 and p < 0.001, respectively, calculated with paired t-test using log-transformed data).. resembling Shanchol, with both given as a two-dose regimen over 2 weeks [74]. Moreover, based on the non-inferiority data of serum vibriocidal antibody seroconversion, WHO pre-qualified Euvichol for procurement by United Nations agencies.…”

Section: Serious Adverse Eventsmentioning

confidence: 87%

“…Euvichol was licensed by the Korean national regulatory authority based on non-inferiority in the rate of seroconversion compared to Shanchol in a head-to-head comparison [74]. Moreover, based on studies in Kolkata and Dhaka that documented rises in titer of serum vibriocidal antibodies following the first of two doses of Shanchol [77,78], it was proposed that this vaccine might protect following the ingestion of a single oral dose.…”

Section: Expert Commentarymentioning

confidence: 99%

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PaxVax CVD 103-HgR single-dose live oral cholera vaccine

Levine

Chen

Kaper

et al. 2017

Expert Review of Vaccines

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Section: Serious Adverse Eventsmentioning

confidence: 87%

Section: Expert Commentarymentioning

confidence: 99%

PaxVax CVD 103-HgR single-dose live oral cholera vaccine

Levine

Chen

Kaper

et al. 2017

Expert Review of Vaccines

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“…It has the same formulation as Shanchol (the 2 vaccines are essentially identical) and clinical studies have demonstrated immunological non-inferiority, as to Shanchol. 37 The entry of Euvichol into the market is expected to significantly increase vaccine availability and use. Similar non-inferiority evaluations are underway for another formulation of WC-OCV, Cholvax (Incepta, Bangladesh).…”

Section: Modified Killed Whole Cell Only Vaccinesmentioning

confidence: 99%

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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“…Currently, three such vaccines have been approved for human use. However, these oral WCK vaccines (Dukoral, Shanchol, and Euvichol) offer incomplete protection for a limited time in adults, and are less effective in children [3, 4]. These vaccines require two doses, two weeks apart, with a booster every two years.…”

Section: Introductionmentioning

confidence: 99%

Production of putative enhanced oral cholera vaccine strains that express toxin-coregulated pilus

Hauke

Taylor

2017

PLoS ONE

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The use of whole cell killed (WCK) oral cholera vaccines is an important strategy for cholera prevention in endemic areas. To overcome current vaccine limitations, we engineered strains of V. cholerae to be non-toxigenic and to express the protective protein colonization factor, toxin-coregulated pilus (TCP), under scale-up conditions potentially amenable to vaccine production. Two V. cholerae clinical strains were selected and their cholera toxin genes deleted. The tcp operon was placed under control of a rhamnose-inducible promoter. Production and stability of TCP were assessed under various conditions. The strains lack detectable cholera toxin production. The addition of 0.1% rhamnose to the growth medium induced robust production of TCP and TcpA antigen. The strains produced intact TCP in larger growth volumes (1 L), and pili appeared stable during heat-killing or acid treatment of the bacterial cultures. To date, no WCK cholera vaccines have included TCP. We have constructed putative strains of V. cholerae for use in a vaccine that produce high levels of stable TCP antigen, which has not previously been achieved.

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A randomized, non-inferiority trial comparing two bivalent killed, whole cell, oral cholera vaccines (Euvichol vs Shanchol) in the Philippines

Cited by 61 publications

References 11 publications

PaxVax CVD 103-HgR single-dose live oral cholera vaccine

PaxVax CVD 103-HgR single-dose live oral cholera vaccine

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

Production of putative enhanced oral cholera vaccine strains that express toxin-coregulated pilus

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