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was withdrawn because of a causal association with intussusception.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
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.