A randomized, observer-blinded, equivalence trial comparing two variations of Euvichol®, a bivalent killed whole-cell oral cholera vaccine, in healthy adults and children in the Philippines

Russo, Paola; Ligsay, Antonio D.; Olveda, Remigio M.; Choi, Seo‐Hyun; Kim, Deok Ryun; Park, Ju Yeon; Park, Ju Yeong; Syed, Khalid; Dey, Ayan; Kim, Yang‐Hee; Lee, Sung Hee; Kim, Jayoung; Chon, Yun; Digilio, Laura; Kim, Chan Wha; Excler, Jean Louis

doi:10.1016/j.vaccine.2018.05.102

Cited by 8 publications

(10 citation statements)

References 16 publications

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“…Following this study, in September 2016, the TM-free Euvichol obtained WHO prequalification. Subsequently, clinical data became available supporting the equivalence for safety and immunogenicity between the two Euvichol variations [ 27 ]. In conclusion, the pulmonary mouse cholera model represents a good candidate to examine in vivo the potency of cholera vaccines.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of a bivalent killed thimerosal-free oral cholera vaccine, Euvichol, in an animal model

Lee

Rho

et al. 2018

Clin Exp Vaccine Res

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PurposeAn oral cholera vaccine (OCV), Euvichol, with thimerosal (TM) as preservative, was prequalified by the World Health Organization (WHO) in 2015. In recent years, public health services and regulatory bodies recommended to eliminate TM in vaccines due to theoretical safety concerns. In this study, we examined whether TM-free Euvichol induces comparable immunogenicity to its TM-containing formulation in animal model.Materials and MethodsTo evaluate and compare the immunogenicity of the two variations of OCV, mice were immunized with TM-free or TM-containing Euvichol twice at 2-week interval by intranasal or oral route. One week after the last immunization, mice were challenged with Vibrio cholerae O1 and daily monitored to examine the protective immunity against cholera infection. In addition, serum samples were obtained from mice to measure vibriocidal activity and vaccine-specific IgG, IgM, and IgA antibodies using vibriocidal assay and enzyme-linked immunosorbent assay, respectively.ResultsNo significant difference in immunogenicity, including vibriocidal activity and vaccine-specific IgG, IgM, and IgA in serum, was observed between mice groups administered with TM-free and -containing Euvichol, regardless of immunization route. However, intranasally immunized mice elicited higher levels of serum antibodies than those immunized via oral route. Moreover, intranasal immunization completely protected mice against V. cholerae challenge but not oral immunization. There was no significant difference in protection between two Euvichol variations.ConclusionThese results suggested that TM-free Euvichol could provide comparable immunogenicity to the WHO prequalified Euvichol containing TM as it was later confirmed in a clinical study. The pulmonary mouse cholera model can be considered useful to examine in vivo the potency of OCVs.

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Section: Discussionmentioning

confidence: 99%

Immunogenicity of a bivalent killed thimerosal-free oral cholera vaccine, Euvichol, in an animal model

Lee

Rho

et al. 2018

Clin Exp Vaccine Res

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“…The efficacy of Shanchol is about 65% protection based on a 5-year study 17 . In clinical studies in the Philippines, Euvichol was effective in adults and children 18, 32 . Shanchol and Euvichol are intended for all patients who are at least 1 year old but not for pregnant women 16, 18 .…”

Section: Vaccinesmentioning

confidence: 99%

“…In clinical studies in the Philippines, Euvichol was effective in adults and children 18, 32 . Shanchol and Euvichol are intended for all patients who are at least 1 year old but not for pregnant women 16, 18 . Furthermore, there are two variations of Euvichol (with or without the preservative thimerosal), both of which show no significant difference in protection 32 .…”

Section: Vaccinesmentioning

confidence: 99%

“…The El Tor biotype can be grouped into the serotypes Ogawa and Inaba, which are the most prevalent serotypes that are causing the pandemics 2, 14, 15 , and these are used in contemporary vaccines like Shanchol and Euvichol 16 . Even with modern-day treatments, it is estimated that there are over 3 million cases of cholera with more than 100,000 deaths annually 16– 18 . The World Health Organization (WHO) public database of annual epidemic cholera cases provides outbreak updates and a summary of worldwide infections 19 .…”

Section: Introductionmentioning

confidence: 99%

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Combating Cholera

Hsueh

Waters

2019

F1000Res

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Cholera infections caused by the gamma-proteobacterium Vibrio cholerae have ravaged human populations for centuries, and cholera pandemics have afflicted every corner of the globe. Fortunately, interventions such as oral rehydration therapy, antibiotics/antimicrobials, and vaccines have saved countless people afflicted with cholera, and new interventions such as probiotics and phage therapy are being developed as promising approaches to treat even more cholera infections. Although current therapies are mostly effective and can reduce disease transmission, cholera outbreaks remain deadly, as was seen during recent outbreaks in Haiti, Ethiopia, and Yemen. This is due to significant underlying political and socioeconomic complications, including shortages of vaccines and clean food and water and a lack of health surveillance. In this review, we highlight the strengths and weaknesses of current cholera therapies, discuss emerging technologies, and argue that a multi-pronged, flexible approach is needed to continue to reduce the worldwide burden of cholera.

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“…Euvichol was demonstrated to be well tolerated and immunogenic. 232,233 At a twodose regimen, Euvichol induced vibriocidal responses at a level comparable to Shanchol. 234 Modified by removing thimerosal preservative and packing in plastic tubes instead of glass vials, Euvichol becomes more efficient for vaccine stockpile, transportation, and administer.…”

Section: Euvichol (Euvichol-plus)mentioning

confidence: 99%

Vaccines against gastroenteritis, current progress and challenges

2020

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Enteric viral and bacterial infections continue to be a leading cause of mortality and morbidity in young children in low-income and middle-income countries, the elderly, and immunocompromised individuals. Vaccines are considered an effective and practical preventive approach against the predominantly fecal-to-oral transmitted gastroenteritis particularly in the resource-limited countries or regions where implementation of sanitation systems and supply of safe drinking water are not quickly achievable. While vaccines are available for a few enteric pathogens including rotavirus and cholera, there are no vaccines licensed for many other enteric viral and bacterial pathogens. Challenges in enteric vaccine development include immunological heterogeneity among pathogen strains or isolates, a lack of animal challenge models to evaluate vaccine candidacy, undefined host immune correlates to protection, and a low protective efficacy among young children in endemic regions. In this article, we briefly updated the progress and challenges in vaccines and vaccine development for the leading enteric viral and bacterial pathogens including rotavirus, human calicivirus, Shigella, enterotoxigenic Escherichia coli (ETEC), cholera, nontyphoidal Salmonella, and Campylobacter, and introduced a novel epitope-and structurebased vaccinology platform known as MEFA (multiepitope fusion antigen) and the application of MEFA for developing broadly protective multivalent vaccines against heterogenous pathogens.

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A randomized, observer-blinded, equivalence trial comparing two variations of Euvichol®, a bivalent killed whole-cell oral cholera vaccine, in healthy adults and children in the Philippines

Abstract: HighlightsBridging study demonstrating the equivalence of two variations of Euvichol®.The 600L thimerosal-free Euvichol® is safe and immunogenic in adults and children.The scale-up of Euvichol® allows expanding global access to oral cholera vaccine.

Cited by 8 publications

References 16 publications

Immunogenicity of a bivalent killed thimerosal-free oral cholera vaccine, Euvichol, in an animal model

Immunogenicity of a bivalent killed thimerosal-free oral cholera vaccine, Euvichol, in an animal model

Combating Cholera

Vaccines against gastroenteritis, current progress and challenges

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