H Fred Clark1, Paul A Offit, Stanley A Plotkin, Penny M Heaton. 1. Division of Infectious Diseases, ARC 1202, Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, 19104, USA. clarkf@email.chop.edu
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 A licensed vaccine against rotavirus was withdrawn because of a causal association with intussusception.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.
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 A licensed vaccine against rotavirus was withdrawn because of a causal association with intussusception.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: Scott A Brown; Sherri L Surman; Robert Sealy; Bart G Jones; Karen S Slobod; Kristen Branum; Timothy D Lockey; Nanna Howlett; Pamela Freiden; Patricia Flynn; Julia L Hurwitz Journal: Viruses Date: 2010-02-01 Impact factor: 5.048