The New Pentavalent Rotavirus Vaccine Composed of Bovine (Strain WC3) -Human Rotavirus Reassortants


By jpeza - Posted on 07 Julio 2009

Fecha Publicación: 
1 Ene 2006
Datos del paper
Autor Principal: 
H. Fred Clark
Volumen: 
25
Página Inicial: 
577
Página Final: 
583
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was withdrawn because of a causal association with intussusception.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.

Dirección del Autor: 

*Children’s Hospital and University of Pennsylvania School of

Medicine, Philadelphia, PA; and †Merck Research Laboratories, West

Point, PA.

Keywords: 
rotavirus
gastroenteritis
intussusception
reassortant
Coautores: 

DVM, PhD,* Paul A. Offit, MD,* Stanley A. Plotkin, MD,*

and Penny M. Heaton, MD, MPH†

AdjuntoTamaño
[file] Pediatric_Infectious_ Disease_ Journal_2006_25_pp577 -583.pdf1.13 MB