Safety and immunogenicity of live, attenuated human rotavirus vaccine 89-12

Bernstein, David I.; Smith, Vicki; Sherwood, James R.; Schiff, Gilbert M.; Sander, Donna S.; DeFeudis, Donna; Spriggs, Dale R.; Ward, Richard L.

doi:10.1016/s0264-410x(97)00210-7

Cited by 184 publications

(102 citation statements)

References 36 publications

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“…Thus, these assays are very similar and the results should in principle be comparable. For a typical experiment, ELISA plates are sequentially treated with: 1) rabbit anti-RV IgG; 2) lysate of virus-infected cells (WC3, 61 62 and presumably the RIX4414 virus lysates for the RV5, 89-12, and RV1 vaccines, respectively) or the lysate of mock-infected cells used as a negative control; 3) a human serum pool (used as a RV-IgA standard) or test serum samples (starting with a dilution of 1:20) are added to both wells with or without virus; 4) Biotinylated rabbit anti-human IgA and finally Peroxidase Conjugated Avidin/Biotin and a colorimetric developing reagent.…”

Section: Technical Aspects Of the Immunological Assays Usedmentioning

confidence: 99%

“…62 Moreover, the poor capacity of children to develop serum RV-NA was associated with the presence of maternal antibodies, and age at immunization. Children vaccinated at 4 or 6 months of age showed higher RV-NA seroconversion rates (75-79%), but are, nonetheless, lower than RV-IgA seroconversion rates and the protective efficacy of the vaccine.…”

Section: Rv5 and Its Precursorsmentioning

confidence: 99%

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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: Technical Aspects Of the Immunological Assays Usedmentioning

confidence: 99%

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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“…In 1999, however, due to a rare association between vaccine use and severe bowel obstruction in vaccinees, the vaccine was withdrawn from the US market (CDC, 1999a, b). Despite these serious adverse effects of vaccination with RotaShield, further efforts at finding safe and effective vaccines are under way (Clark et al, 1996;Bernstein et al, 1998;Clements-Mann et al, 2001).…”

Section: Introductionmentioning

confidence: 99%

Molecular epidemiology of human P[8],G9 rotaviruses in Hungary between 1998 and 2001

Bányai

Gentsch

Schipp

et al. 2004

Journal of Medical Microbiology

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“…Another live vaccine, thus far used only in the military to prevent epidemic pneumonia, consists of adeno 4 and 7 viruses grown in human diploid cell strains and administered orally to replicate in the intestine (23). Other live vaccines attenuated in cell-culture passage are the monovalent rotavirus vaccine attenuated by passage in Vero cells (24) and the Japanese encephalitis strain SA14-14-2 (25).…”

Section: Cell Culturementioning

confidence: 99%