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

Pedro A. Piedra, Stanley G. Cron, Alan Jewell, Nicole Hamblett, Ruth McBride, Melisa A. Palacio, Richard Ginsberg, Christopher M. Oermann, Peter W. Hiatt, S. McColley, M. Bowman, D. Borowitz, R. Castile, K. McCoy, C. Prestige, M. E. Brown, J. Stevens, W. Regelmann, C. Milla, P. SammutJ. Colombo, J. Eisenberg, T. D. Murphy, J. Finder, G. Kurland, G. Winnie, D. Orenstein, K. Voter, M. Light, M. S. Pian, C. Harris, D. Stokes, R. Fink, C. Ren, J. Gorvoy, L. Varlotta, M. Dyson

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85 Scopus citations


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 0.37log2 per month, respectively. The PFP-3 vaccine-induced a robust immune response that lasted throughout the RSV season.

Original languageEnglish (US)
Pages (from-to)2448-2460
Number of pages13
Issue number19-20
StatePublished - Jun 2 2003

Bibliographical note

Funding Information:
Presented in part at Fourteenth Annual North American Cystic Fibrosis Conference, November 11, 2000, Baltimore, Maryland, Support: Collaborative Research Agreement between the Cystic Fibrosis Foundation and Wyeth-Lederle Vaccines; Cystic Fibrosis Foundation grant number: Piedra-99AO.


  • Children with cystic fibrosis
  • RSV vaccine
  • Respiratory syncytial virus


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