Phase-I study MEDI-534, of a live, attenuated intranasal vaccine against respiratory syncytial virus and parainfluenza-3 virus in seropositive children

Pediatr Infect Dis J. 2009 Jul;28(7):655-8. doi: 10.1097/INF.0b013e318199c3b1.

Abstract

A live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine was evaluated in healthy respiratory syncytial virus/parainfluenza virus type 3 seropositive children aged 1 to 9 years. Three cohorts of 40 children were randomized 1:1 to receive 10, 10, or 10 median tissue culture infectious dose50 MEDI-534 vaccine or placebo. The vaccine's safety profile was similar to placebo, no viral shedding was detected, and the vaccine was minimally immunogenic.

Trial registration: ClinicalTrials.gov NCT00345670.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Child
  • Child, Preschool
  • Feces / virology
  • Female
  • Human Experimentation
  • Humans
  • Infant
  • Male
  • Parainfluenza Vaccines / administration & dosage
  • Parainfluenza Vaccines / adverse effects
  • Parainfluenza Vaccines / immunology*
  • Parainfluenza Virus 3, Human / immunology*
  • Paramyxoviridae Infections / prevention & control*
  • Placebos / administration & dosage
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Respiratory Syncytial Virus Vaccines / administration & dosage
  • Respiratory Syncytial Virus Vaccines / adverse effects
  • Respiratory Syncytial Virus Vaccines / immunology*
  • Respiratory Syncytial Viruses / immunology*
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology
  • Virus Shedding

Substances

  • Parainfluenza Vaccines
  • Placebos
  • Respiratory Syncytial Virus Vaccines
  • Vaccines, Attenuated

Associated data

  • ClinicalTrials.gov/NCT00345670