Safety and immunogenicity of a purified F protein respiratory syncytial virus (PFP-2) vaccine in seropositive children with bronchopulmonary dysplasia

J Infect Dis. 1998 Feb;177(2):467-9. doi: 10.1086/517377.

Abstract

Respiratory syncytial virus (RSV) causes serious respiratory illness in preterm children with bronchopulmonary dysplasia. In a prospective randomized placebo-controlled trial, 21 children received one dose of PFP-2 (purified fusion [F] protein) vaccine or influenza vaccine (placebo). Children were followed for adverse reactions and RSV illness over two respiratory seasons. Sera were obtained for determination of IgG titers to RSV F protein and neutralizing antibody titers before and 1, 6, and 12 months after vaccination. Adverse reactions were few. Four-fold F protein rises occurred in 9 of 10 PFP-2 and 0 of 11 placebo recipients. Six PFP-2 recipients had low prevaccination neutralizing antibody titers (< 1:450); all had 4-fold rises. By 12 months, F protein and neutralizing antibody titers in all 21 children were similar. RSV illness occurred in 6 of 11 placebo versus 1 of 10 PFP-2 recipients (P = .06); 1 placebo child required hospitalization. PFP-2 vaccine appears safe and immunogenic and may protect children with bronchopulmonary dysplasia against serious RSV disease on reinfection.

Publication types

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

MeSH terms

  • Antibodies, Viral / analysis
  • Antibodies, Viral / immunology
  • Bronchopulmonary Dysplasia / virology*
  • Child, Preschool
  • Double-Blind Method
  • HN Protein*
  • Hospitalization
  • Humans
  • Immunoglobulin G / analysis
  • Immunoglobulin G / immunology
  • Infant, Newborn
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / adverse effects
  • Influenza Vaccines / immunology
  • Neutralization Tests
  • Prospective Studies
  • Respiratory Syncytial Virus Infections / immunology*
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Seasons
  • Viral Envelope Proteins
  • Viral Proteins / immunology*
  • Viral Vaccines / administration & dosage
  • Viral Vaccines / adverse effects*
  • Viral Vaccines / immunology*

Substances

  • Antibodies, Viral
  • HN Protein
  • Immunoglobulin G
  • Influenza Vaccines
  • Viral Envelope Proteins
  • Viral Proteins
  • Viral Vaccines
  • attachment protein G