The Pediatric infectious disease journal · 2006
The new pentavalent rotavirus vaccine composed of bovine (strain WC3) -human rotavirus reassortants.
СтатьяОбзорНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Clark H Fred, Offit Paul A, Plotkin Stanley A, Heaton Penny M
Аннотация
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 A licensed vaccine against rotavirus was withdrawn because of a causal association with intussusception.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.
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.