Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults

Anh, Đặng Đức; Canh, Do Gia; Lopez, Anna Lena; Thiem, Vu Dinh; Long, Phan Thi; Sơn, Nguyễn Hồng; Deen, Jacqueline; Seidlein, Lorenz von; Carbis, Rodney; Han, Seung Hyun; Shin, Seong Hye; Attridge, Stephen R.; Holmgren, Jan; Clemens, John D.

doi:10.1016/j.vaccine.2006.09.049

Cited by 96 publications

(67 citation statements)

References 13 publications

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“…A reduction in vaccine immunogenicity among infants positive for rotavirus-specific IgA was recently observed during studies of Rotarix conducted in Zambia [23], Bangladesh [135] and South Africa [36], but not in India [175]. Pre-vaccination exposure seems to have a similar effect on the immunogenicity of oral cholera vaccines, including both live-attenuated [11,93,176] and inactivated vaccines [96,177,178]. Together, these findings suggest that the induc-tion of immunity following a previous encounter with a pathogen may contribute to the impaired immunogenicity of oral vaccines in high-transmission settings.…”

Section: Transmission Intensity and Strain Diversity Of The Infectious mentioning

confidence: 88%

Causes of Impaired Oral Vaccine Efficacy in Developing Countries

et al. 2017

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Oral vaccines are less immunogenic when given to infants in low-income compared with high-income countries, limiting their potential public health impact. Here, we review factors that might contribute to this phenomenon, including transplacental antibodies, breastfeeding, histo blood group antigens, enteric pathogens, malnutrition, microbiota dysbiosis and environmental enteropathy. We highlight several clear risk factors for vaccine failure, such as the inhibitory effect of enteroviruses on oral poliovirus vaccine. We also highlight the ambiguous and at times contradictory nature of the available evidence, which undoubtedly reflects the complex and interconnected nature of the factors involved. Mechanisms responsible for diminished immunogenicity may be specific to each oral vaccine. Interventions aiming to improve vaccine performance may need to reflect the diversity of these mechanisms. Enteric pathogens are a substantial threat to public health. This threat takes many forms, from the toxin-producing bacteria (e.g., Vibrio cholerae) and flagellated protozoa (e.g., Giardia lamblia) that colonize the mucosal surface of the small intestine to the enteroviruses that are capable of spreading via the bloodstream to the CNS, causing acute flaccid paralysis (e.g., poliovirus). Each year, enteric pathogens cause hundreds of millions of cases of diarrhea and approximately 800,000 deaths, the vast majority of which occur among children in low-income countries [1]. The most common causes of childhood diarrheal morbidity include rotavirus, Cryptosporidium, enterotoxigenic Escherichia coli and Shigella [2].Vaccines against enteric pathogens are important tools for mitigating this disease burden. Oral vaccines offer several distinct benefits compared with parenteral vaccines. They can be produced in large quantities at relatively low cost, are easy to administer and have the capacity to induce local immunity in the intestinal mucosa, thereby protecting vaccinated individuals against subsequent infection and -by blocking onward transmission -enhancing herd immunity [3,4]. Currently licensed oral vaccines include live-attenuated poliovirus vaccines containing one, two or three serotypes, live-attenuated rotavirus vaccines (Rotarix R , RotaTeq R , Lanzhou lamb rotavirus vaccine [China only] and Rotavac R [India only]), live-attenuated cholera vaccine (CVD 103-HgR or Vaxchora TM ), inactivated cholera vaccines (Dukoral R and Shanchol R ) and live-attenuated typhoid vaccine (Ty21a). Other oral vaccines are in development, including those against Shigella, enterotoxigenic E. coli, Campylobacter and Clostridium difficile, as well as several novel rotavirus vaccine candidates (including the human neonatal vaccine RV3-BB [5] and an oral bovine pentavalent vaccine [6]).Yet oral vaccines have an Achilles' heel -their immunogenicity and efficacy is impaired in low-income countries that experience the greatest burden of enteric disease (Box 1). For example, Rotarix has a 1-year protective efficacy against severe rotavirus-associated gas...

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Section: Transmission Intensity and Strain Diversity Of The Infectious mentioning

confidence: 88%

Causes of Impaired Oral Vaccine Efficacy in Developing Countries

et al. 2017

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“…In those cases, short-to medium-term strategies such as vaccination against cholera may be more useful [6]. At the present, only one cholera vaccine, Dukoral, is internationally licensed and available [7], and mOROVAC (http://www.vabiotechvn.com) is used only in Vietnam [8]. Some vaccine projects are in development, such as the attenuated vaccines Peru 15, CVD 110, 111 and 112 strains [9] and 638 strain [10]) and the inactivated whole cells and subunit vaccines [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Is cholera disease associated with poverty?

Talavera

Pérez

2009

J Infect Dev Ctries

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Background: Cholera remains a global threat and is one of the key indicators of social development. While the disease no longer poses a menace to countries with minimum standards of hygiene, it remains a serious challenge to countries where access to safe drinking water and adequate sanitation cannot be guaranteed. The objective of this work was to analyse the results obtained when contrasting the reports of the World Health Organization (WHO) about cholera disease with those of the World Bank List of economies (countries). Methodology: Data were obtained from reports of two international organizations, the report on cholera disease incidence of the World Health Organization and the World Bank's classification of countries attending to their income. Results: We determined that low-income countries are more affected by cholera disease than countries with middle or high income. This difference was reflected in the percent of countries, the total number of reported cases, the number of cases per 100,000 habitants, as well as in the reported mortality. These results support the phrase "cholera disease is a disease of poverty." Conclusions: We consider that economic development is an important factor in the morbidity and mortality of cholera, together with environment, climate, culture, medical management, political intention, and the intrinsic factors of the system.

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“…In Vietnam, a locally produced WCK vaccine that lacks CTB, making it more affordable, has had around 66% efficacy (78). A new version of the Vietnam vaccine, reformulated to meet WHO standards, has achieved 67% protective efficacy, even in children as young as 1 year old, in an area where cholera is endemic (74); it contains a mixture of O1 and O139 WCK V. cholerae and has proven to be immunogenic toward both serogroups, but with a stronger response to O1 than O139 (8). Live attenuated V. cholerae vaccines are also orally delivered and provide an interesting alternative approach, as reviewed in reference 66.…”

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confidence: 99%

Mucosal Immunization with Vibrio cholerae Outer Membrane Vesicles Provides Maternal Protection Mediated by Antilipopolysaccharide Antibodies That Inhibit Bacterial Motility

et al. 2010

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Vibrio cholerae is the causative agent of cholera, a severe diarrheal disease that remains endemic in many parts of the world and can cause outbreaks wherever sanitation and clean water systems break down. Prevention of disease could be achieved through improved sanitation and clean water provision supported by vaccination. V. cholerae serogroup O1 is the major cause of cholera; O1 serotypes Inaba and Ogawa have similar disease burdens, while O139 is the only non-O1 serogroup to cause epidemics. We showed previously that immunization of adult female mice with purified V. cholerae outer membrane vesicles (OMVs) elicits an antibody response that protect neonates from oral V. cholerae challenge and that suckling from an immunized dam accounts for the majority of protection from V. cholerae colonization. Here we report that lipopolysaccharide (LPS) is the major OMV protective antigen. Mucosal immunization with OMVs from Inaba or Ogawa provides significant cross-serotype protection from V. cholerae colonization, although serotype-specific antigens are dominant. OMVs from O1 or O139 do not provide cross-serogroup protection, but by immunization with a mixture of O1 and O139 OMVs, cross-serogroup protection was achieved. Neonatal protection is not associated with significant bacterial death but may involve inhibition of motility, as antibodies from OMVimmunized mice inhibit V. cholerae motility in vitro, with trends that parallel in vivo protection. Motility assays also reveal that a higher antibody titer is required to immobilize O139 compared to O1, a phenotype that is O139 capsule dependent.

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Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults

Cited by 96 publications

References 13 publications

Causes of Impaired Oral Vaccine Efficacy in Developing Countries

Causes of Impaired Oral Vaccine Efficacy in Developing Countries

Is cholera disease associated with poverty?

Mucosal Immunization with Vibrio cholerae Outer Membrane Vesicles Provides Maternal Protection Mediated by Antilipopolysaccharide Antibodies That Inhibit Bacterial Motility

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