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The new pentavalent rotavirus vaccine composed of bovine (strain WC3) -human rotavirus reassortants.
Pediatr Infect Dis J 2006; 25(7):577-83PI

Abstract

BACKGROUND

Infantile gastroenteritis caused by human rotaviruses is a prevalent disease throughout the world, causing dehydration and hospitalization in all countries. In developing countries, it is associated with a high mortality. A licensed vaccine against rotavirus was withdrawn because of a causal association with intussusception. A new vaccine has been developed and is a candidate for licensure.

METHODS

To recount the early development and recent demonstration of the safety and efficacy of the new vaccine. A bovine rotavirus attenuated for humans was isolated and reassorted with human rotaviruses of serotypes G1-4 and P1 to create a pentavalent vaccine. Multiple placebo-controlled clinical trials, including one involving approximately 70,000 infants, were conducted in multiple developed countries.

RESULTS

The pentavalent vaccine was well tolerated by infants less than 8 months of age, and the incidence of intussusception was similar among vaccine and placebo recipients. More than 90% of infants had a significant rise in serum antirotavirus IgA titer after 3 doses. Efficacy of 95% against severe disease causing hospitalization or emergency care was demonstrated, and pentavalent vaccine prevented 74% of all rotavirus disease.

CONCLUSIONS

If widely used, pentavalent vaccine would control rotavirus disease in the United States and other developed countries and could also have a major effect in developing countries.

Authors+Show Affiliations

Division of Infectious Diseases, ARC 1202, Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, 19104, USA. clarkf@email.chop.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

16804425

Citation

Clark, H Fred, et al. "The New Pentavalent Rotavirus Vaccine Composed of Bovine (strain WC3) -human Rotavirus Reassortants." The Pediatric Infectious Disease Journal, vol. 25, no. 7, 2006, pp. 577-83.
Clark HF, Offit PA, Plotkin SA, et al. The new pentavalent rotavirus vaccine composed of bovine (strain WC3) -human rotavirus reassortants. Pediatr Infect Dis J. 2006;25(7):577-83.
Clark, H. F., Offit, P. A., Plotkin, S. A., & Heaton, P. M. (2006). The new pentavalent rotavirus vaccine composed of bovine (strain WC3) -human rotavirus reassortants. The Pediatric Infectious Disease Journal, 25(7), pp. 577-83.
Clark HF, et al. The New Pentavalent Rotavirus Vaccine Composed of Bovine (strain WC3) -human Rotavirus Reassortants. Pediatr Infect Dis J. 2006;25(7):577-83. PubMed PMID: 16804425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The new pentavalent rotavirus vaccine composed of bovine (strain WC3) -human rotavirus reassortants. AU - Clark,H Fred, AU - Offit,Paul A, AU - Plotkin,Stanley A, AU - Heaton,Penny M, PY - 2006/6/29/pubmed PY - 2006/8/9/medline PY - 2006/6/29/entrez SP - 577 EP - 83 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 25 IS - 7 N2 - BACKGROUND: Infantile gastroenteritis caused by human rotaviruses is a prevalent disease throughout the world, causing dehydration and hospitalization in all countries. In developing countries, it is associated with a high mortality. A licensed vaccine against rotavirus was withdrawn because of a causal association with intussusception. A new vaccine has been developed and is a candidate for licensure. METHODS: To recount the early development and recent demonstration of the safety and efficacy of the new vaccine. A bovine rotavirus attenuated for humans was isolated and reassorted with human rotaviruses of serotypes G1-4 and P1 to create a pentavalent vaccine. Multiple placebo-controlled clinical trials, including one involving approximately 70,000 infants, were conducted in multiple developed countries. RESULTS: The pentavalent vaccine was well tolerated by infants less than 8 months of age, and the incidence of intussusception was similar among vaccine and placebo recipients. More than 90% of infants had a significant rise in serum antirotavirus IgA titer after 3 doses. Efficacy of 95% against severe disease causing hospitalization or emergency care was demonstrated, and pentavalent vaccine prevented 74% of all rotavirus disease. CONCLUSIONS: If widely used, pentavalent vaccine would control rotavirus disease in the United States and other developed countries and could also have a major effect in developing countries. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/16804425/The_new_pentavalent_rotavirus_vaccine_composed_of_bovine__strain_WC3___human_rotavirus_reassortants_ L2 - http://dx.doi.org/10.1097/01.inf.0000220283.58039.b6 DB - PRIME DP - Unbound Medicine ER -