Purified fusion protein vaccine protects against lower respiratory tract illness during respiratory syncytial virus season in children with cystic fibrosis

Pediatr Infect Dis J. 1996 Jan;15(1):23-31. doi: 10.1097/00006454-199601000-00006.


Objective: To test in a double blind, placebo-controlled study a purified fusion protein (PFP-2) vaccine against respiratory syncytial virus (RSV) in RSV-seropositive children with cystic fibrosis (CF).

Methods: Seventeen CF children, mean age 4.5 years, received PFP-2 vaccine and 17 CF children, mean age 5.8 years, received a saline vaccine. At enrollment the Shwachman clinical score, Brasfield radiographic score, oxygen saturation (SpO2), anthropometric indices and other variables were recorded. After vaccination the reactions were assessed daily for 7 days. During the RSV season weekly telephone interviews were performed and children with an acute respiratory illness were evaluated and cultured for RSV. Serum was drawn before vaccination, 1 month after vaccination and at the end of the RSV season and tested for antibodies to RSV.

Results: Other than age the baseline measurements at enrollment were similar between groups. The PFP-2 vaccine produced mild local reactions and induced a significant neutralizing antibody response in two-thirds of the vaccinees and a significant enzyme-linked immunosorbent assay-fusion glycoprotein antibody response in nearly all the PFP-2 vaccinees. Vaccine-enhanced disease was not observed in PFP-2 vaccines infected with RSV. Protection against RSV infection was not observed; however, a significant reduction (t test, P < 0.01) in mean number of lower respiratory tract illnesses (0.8 vs. 2.1), antibiotic courses (2.2 vs 4.5) and days ill (30.5 vs. 67) occurred among RSV-infected PFP-2 vaccinees.

Conclusions: Efficacy of the PFP-2 vaccine against lower respiratory tract illness during the RSV season was shown in RSV-seropositive children with CF.

Publication types

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

MeSH terms

  • Child
  • Child Nutritional Physiological Phenomena
  • Child, Preschool
  • Cystic Fibrosis / complications
  • Cystic Fibrosis / virology*
  • Double-Blind Method
  • Environment
  • HN Protein*
  • Humans
  • Infant
  • Placebos
  • Respiratory Syncytial Virus Infections / complications
  • Respiratory Syncytial Virus Infections / immunology
  • Respiratory Syncytial Virus Infections / prevention & control*
  • Respiratory Syncytial Viruses / chemistry
  • Respiratory Syncytial Viruses / immunology
  • Respiratory Syncytial Viruses / isolation & purification
  • Severity of Illness Index
  • Vaccination*
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology
  • Vaccines, Synthetic / therapeutic use
  • Viral Envelope Proteins
  • Viral Proteins / immunology*
  • Viral Vaccines / adverse effects
  • Viral Vaccines / immunology
  • Viral Vaccines / therapeutic use


  • HN Protein
  • Placebos
  • Vaccines, Synthetic
  • Viral Envelope Proteins
  • Viral Proteins
  • Viral Vaccines
  • attachment protein G