Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus: a multi-center trial in children with cystic fibrosis

Vaccine. 2003 Jun 2;21(19-20):2448-60. doi: 10.1016/s0264-410x(03)00098-7.


A third generation, purified fusion protein (PFP-3) vaccine was developed to prevent severe respiratory syncytial virus (RSV) disease in high-risk groups. A phase II, multi-center, adjuvant-controlled trial was performed in RSV seropositive children with cystic fibrosis (CF); 151 received the adjuvant-control and 143 received the vaccine. Details of the vaccine-induced immune response are presented. At enrollment, RSV-specific, serum antibodies were comparable between both groups. A highly sensitive and specific serum antibody vaccine profile was established for the PFP-3 vaccine. At post-vaccination and end-of-study, RSV-specific, neutralizing antibody (Nt Ab) and binding antibody (Bd Ab) to the fusion (F) protein were significantly higher in PFP-3 vaccinees. After 28 days post-vaccination, Nt Ab and Bd Ab to F protein titers declined slowly at rates of 0.23 and 0.37 log2 per month, respectively. The PFP-3 vaccine-induced a robust immune response that lasted throughout the RSV season.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Child
  • Child, Preschool
  • Cystic Fibrosis / complications
  • Cystic Fibrosis / immunology*
  • Female
  • Humans
  • Immunization Schedule
  • Infant
  • Male
  • Patient Selection
  • Recombinant Fusion Proteins / immunology
  • Recombinant Fusion Proteins / therapeutic use
  • Respiratory Syncytial Virus Infections / epidemiology
  • Respiratory Syncytial Virus Infections / immunology*
  • Respiratory Syncytial Virus Infections / prevention & control
  • Respiratory Syncytial Viruses / immunology
  • Respiratory Syncytial Viruses / isolation & purification
  • Seasons
  • Vaccines, Synthetic / immunology*
  • Vaccines, Synthetic / therapeutic use
  • Viral Vaccines / immunology*
  • Viral Vaccines / therapeutic use


  • Adjuvants, Immunologic
  • Recombinant Fusion Proteins
  • Vaccines, Synthetic
  • Viral Vaccines