A critical review on a globally-licensed, live, orally-administrable, monovalent human rotavirus vaccine: Rotarix

Expert Opin Biol Ther. 2009 Aug;9(8):1073-86. doi: 10.1517/14712590903103787.

Abstract

Rotavirus is the major cause of severe gastroenteritis in children worldwide, and two, live, orally-administrable vaccines are licensed globally. They are Rotarix, a monovalent, human rotavirus-based vaccine (GlaxoSmithKline), and RotaTeq, a pentavalent, bovine-human reassortant vaccine (Merck). The RIX4414 strain, a G1P[8] virus, is contained in the Rotarix vaccine. It grows efficiently in the human intestine, as evidenced by vaccine virus shedding into faeces. Efficient multiplication of RIX4414 in the intestines may play a role in stimulating immune effectors other than neutralizing antibodies that may explain the protective immunity against fully heterotypic G2P[4] strains. The protective efficacy against severe rotavirus gastroenteritis afforded by Rotarix is consistently better against strains that share with RIX4414 both G and P serotypes (i.e., G1P[8]), or only P serotype (i.e., G3P[8], G4P[8] and G9P[8]). The Rotarix vaccine is safe regarding intussusception if its first dose is administered between 6 and 12 weeks of age and the last dose by 24 weeks of age with a minimum interval of 4 weeks between the two doses. The expansion by Advisory Committee on Immunization Practices, USA, of the age limit for the first dose to age <15 weeks, and the last dose by 8 months requires close monitoring.

Publication types

  • Review

MeSH terms

  • Animals
  • Child, Preschool
  • Clinical Trials as Topic
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Infectious Disease Medicine / trends
  • Intestines / virology
  • Male
  • Rotavirus Infections / immunology
  • Rotavirus Infections / prevention & control*
  • Rotavirus Vaccines / administration & dosage
  • Rotavirus Vaccines / immunology*
  • Rotavirus Vaccines / therapeutic use
  • Vaccines, Attenuated / therapeutic use
  • Virus Shedding

Substances

  • RIX4414 vaccine
  • RotaTeq
  • Rotavirus Vaccines
  • Vaccines, Attenuated