Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants

Clark, H Fred; Bernstein, David I.; Dennehy, Penelope H.; Offit, Paul A.; Pichichero, Michael E.; Treanor, John J.; Ward, Richard L.; Krah, David L.; Shaw, Alan; Dallas, Michael J.; Laura, Digilio; Eiden, Joseph; Ivanoff, Nathalie; Kaplan, Karen M.; Heaton, Penny M.

doi:10.1016/j.jpeds.2003.10.054

Cited by 133 publications

(68 citation statements)

References 27 publications

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“…45,74 Moreover, there seems to be an agreement that measurement of stool RVIgA is technically difficult, and the presence of maternal milk RV-IgA may mask the detection of vaccine induced RV-IgA. 75 It seems doubtful that stool RV antibodies can be used as surrogate endpoint for RV vaccines.…”

Section: Rv5 and Its Precursorsmentioning

confidence: 99%

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Ángel

Steele

Franco

2014

Human Vaccines & Immunotherapeutics

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Rotavirus (RV) is a major vaccine-preventable killer of young children worldwide. Two RV vaccines are globally commercially available and other vaccines are in different stages of development. Due to the absence of a suitable correlate of protection (CoP), all RV vaccine efficacy trials have had clinical endpoints. These trials represent an important challenge since RV vaccines have to be introduced in many different settings, placebo-controlled studies are unethical due to the availability of licensed vaccines, and comparator assessments for new vaccines with clinical endpoints are very large, complex, and expensive to conduct. A CoP as a surrogate endpoint would allow predictions of vaccine efficacy for new RV vaccines and enable a regulatory pathway, contributing to the more rapid development of new RV vaccines. The goal of this review is to summarize experiences from RV natural infection and vaccine studies to evaluate potential CoP for use as surrogate endpoints for assessment of new RV vaccines, and to explore challenges and opportunities in the field.

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Section: Rv5 and Its Precursorsmentioning

confidence: 99%

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Ángel

Steele

Franco

2014

Human Vaccines & Immunotherapeutics

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“…9 RV5 and RV1 have proven highly efficacious and effective in industrialised countries, providing at least 90% protection against severe rotavirus gastroenteritis and at least 74% protection against rotavirus gastroenteritis of any severity. [18][19][20][21][22][23][24] In contrast, studies conducted in low-income countries in Africa and Asia revealed that the efficacy of the 2 vaccines ranged from 56% to 64% in protecting against severe rotavirus gastroenteritis. [25][26][27][28][29][30] In addition, in these settings vaccine efficacy waned between the first and second years after immunisation.…”

Section: Introductionmentioning

confidence: 99%

Options for improving effectiveness of rotavirus vaccines in developing countries

Tissera

Cowley

Bogdanovic-Sakran

et al. 2017

Human Vaccines & Immunotherapeutics

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Rotavirus gastroenteritis is a leading global cause of mortality and morbidity in young children due to diarrhea and dehydration. Over 85% of deaths occur in developing countries. In industrialised countries, 2 live oral rotavirus vaccines licensed in 2006 quickly demonstrated high effectiveness, dramatically reducing severe rotavirus gastroenteritis admissions in many settings by more than 90%. In contrast, the same vaccines reduced severe rotavirus gastroenteritis by only 30-60% in developing countries, but have been proven life-saving. Bridging this "efficacy gap" offers the possibility to save many more lives of children under the age of 5. The reduced efficacy of rotavirus vaccines in developing settings may be related to differences in transmission dynamics, as well as host luminal, mucosal and immune factors. This review will examine strategies currently under study to target the issue of reduced efficacy and effectiveness of oral rotavirus vaccines in developing settings.

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“…The high mortality rate in developing countries and the heavy social and economical burden in industrialized countries due to RV infections underline the need for the development of an efficient vaccine. Every candidate RV vaccine that has been developed to date has consisted of orally delivered, live attenuated RV strains or reassortants (8,9,14,20,36,54,56). Most of these vaccines confer significant protection against severe diarrhea but only limited protection against RV infection or mild symptoms.…”

mentioning

confidence: 99%

Rectal Immunization with Rotavirus Virus-Like Particles Induces Systemic and Mucosal Humoral Immune Responses and Protects Mice against Rotavirus Infection

Parez

Fourgeux

Mohamed

et al. 2006

J Virol

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To evaluate whether the rectal route of immunization may be used to provide appropriate protection against enteric pathogens such as rotaviruses (RV), we studied the antibody response and the protection induced by rectal immunization of mice with RV virus-like particles (VLP). For this purpose, 6-week-old BALBc mice were rectally immunized twice with RV 8-2/6/7-VLP derived from the bovine RV RF81 strain either alone or combined with various adjuvants including four toxins [cholera toxin (CT) and three attenuated Escherichia coli-derived heat-labile toxins (LTs), LT(R192G), LT(R72), and LT ( Rotaviruses (RV) are the leading cause of viral gastroenteritis in young children worldwide and are responsible for more than 500,000 deaths per year in developing countries (40). The high mortality rate in developing countries and the heavy social and economical burden in industrialized countries due to RV infections underline the need for the development of an efficient vaccine. Every candidate RV vaccine that has been developed to date has consisted of orally delivered, live attenuated RV strains or reassortants (8,9,14,20,36,54,56). Most of these vaccines confer significant protection against severe diarrhea but only limited protection against RV infection or mild symptoms. Moreover, live vaccines can be associated with various adverse effects, intussusception being the most severe (33). Thus, the development of new safe vaccine strategies based on nonliving RV should be considered.Virus-like particles (VLP) are nonreplicating structures that mimic virus counterparts in morphology and immunogenicity and could be safe and efficient vaccine candidates. Parenteral immunization with RV VLP has been shown to induce immunogenicity and protection in animal models, particularly in the mouse model (7,11,30). However, RV is commonly transmitted via the fecal-oral route and infects intestinal epithelial cells. Thus, vaccine strategies inducing effective intestinal mucosal immunity responses should be suitable against this pathogen and need to be assessed. RV VLP can be delivered via various mucosal routes of administration in order to induce mucosal effectors. When delivered via the oral route, which is common and handy for vaccine administration, RV VLP induce weak immune responses and do not protect against infection (3, 49). When administered by the nasal route, RV VLP efficiently induce both local and systemic specific immune responses in mice (6,29,34,35) and gnotobiotic pigs (21).

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Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants

Cited by 133 publications

References 27 publications

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Options for improving effectiveness of rotavirus vaccines in developing countries

Rectal Immunization with Rotavirus Virus-Like Particles Induces Systemic and Mucosal Humoral Immune Responses and Protects Mice against Rotavirus Infection

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