The new pentavalent rotavirus vaccine composed of bovine (strain WC3) -human rotavirus reassortants.
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 A licensed vaccine against rotavirus was withdrawn because of a causal association with intussusception.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.
Clark
H Fred
HF
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
Offit
Paul A
PA
Plotkin
Stanley A
SA
Heaton
Penny M
PM
D000818:Animals; D036022:Capsid Proteins / Q000276:immunology; D002417:Cattle; D002675:Child, Preschool; D005260:Female; D005759:Gastroenteritis / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007443:Intussusception / Q000209:etiology / Q000276:immunology; D008297:Male; D051379:Mice; D016032:Randomized Controlled Trials as Topic; D016865:Reassortant Viruses / Q000235:genetics / Q000276:immunology*; D012401:Rotavirus / Q000235:genetics / Q000276:immunology*; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use*
D036022:Capsid Proteins; D022243:Rotavirus Vaccines; C060339:VP4 protein, Rotavirus; C058442:WC3 rotavirus vaccine