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, Paul Henry SammutJohn Louis 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

Research output: Contribution to journalArticle

73 Citations (Scopus)

Abstract

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
JournalVaccine
Volume21
Issue number19-20
DOIs
StatePublished - Jun 2 2003

Fingerprint

Respiratory Syncytial Virus Vaccines
cystic fibrosis
Respiratory Syncytial Viruses
Cystic Fibrosis
Vaccines
immune response
vaccines
viruses
Proteins
antibodies
proteins
Antibodies
Neutralizing Antibodies
neutralizing antibodies
adjuvants
Vaccination
vaccination
risk groups
Virus Diseases
Serum

Keywords

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

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Piedra, P. A., Cron, S. G., Jewell, A., Hamblett, N., McBride, R., Palacio, M. A., ... Dyson, M. (2003). Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus: A multi-center trial in children with cystic fibrosis. Vaccine, 21(19-20), 2448-2460. https://doi.org/10.1016/S0264-410X(03)00098-7

Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus : A multi-center trial in children with cystic fibrosis. / Piedra, Pedro A.; Cron, Stanley G.; Jewell, Alan; Hamblett, Nicole; McBride, Ruth; Palacio, Melisa A.; Ginsberg, Richard; Oermann, Christopher M.; Hiatt, Peter W.; McColley, S.; Bowman, M.; Borowitz, D.; Castile, R.; McCoy, K.; Prestige, C.; Brown, M. E.; Stevens, J.; Regelmann, W.; Milla, C.; Sammut, Paul Henry; Colombo, John Louis; Eisenberg, J.; Murphy, T. D.; Finder, J.; Kurland, G.; Winnie, G.; Orenstein, D.; Voter, K.; Light, M.; Pian, M. S.; Harris, C.; Stokes, D.; Fink, R.; Ren, C.; Gorvoy, J.; Varlotta, L.; Dyson, M.

In: Vaccine, Vol. 21, No. 19-20, 02.06.2003, p. 2448-2460.

Research output: Contribution to journalArticle

Piedra, PA, Cron, SG, Jewell, A, Hamblett, N, McBride, R, Palacio, MA, Ginsberg, R, Oermann, CM, Hiatt, PW, McColley, S, Bowman, M, Borowitz, D, Castile, R, McCoy, K, Prestige, C, Brown, ME, Stevens, J, Regelmann, W, Milla, C, Sammut, PH, Colombo, JL, Eisenberg, J, Murphy, TD, Finder, J, Kurland, G, Winnie, G, Orenstein, D, Voter, K, Light, M, Pian, MS, Harris, C, Stokes, D, Fink, R, Ren, C, Gorvoy, J, Varlotta, L & Dyson, M 2003, 'Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus: A multi-center trial in children with cystic fibrosis', Vaccine, vol. 21, no. 19-20, pp. 2448-2460. https://doi.org/10.1016/S0264-410X(03)00098-7
Piedra, Pedro A. ; Cron, Stanley G. ; Jewell, Alan ; Hamblett, Nicole ; McBride, Ruth ; Palacio, Melisa A. ; Ginsberg, Richard ; Oermann, Christopher M. ; Hiatt, Peter W. ; McColley, S. ; Bowman, M. ; Borowitz, D. ; Castile, R. ; McCoy, K. ; Prestige, C. ; Brown, M. E. ; Stevens, J. ; Regelmann, W. ; Milla, C. ; Sammut, Paul Henry ; Colombo, John Louis ; Eisenberg, J. ; Murphy, T. D. ; Finder, J. ; Kurland, G. ; Winnie, G. ; Orenstein, D. ; Voter, K. ; Light, M. ; Pian, M. S. ; Harris, C. ; Stokes, D. ; Fink, R. ; Ren, C. ; Gorvoy, J. ; Varlotta, L. ; Dyson, M. / Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus : A multi-center trial in children with cystic fibrosis. In: Vaccine. 2003 ; Vol. 21, No. 19-20. pp. 2448-2460.
@article{d3b03d62a52e4c2c84d6d3813a50c6ad,
title = "Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus: A multi-center trial in children with cystic fibrosis",
abstract = "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.",
keywords = "Children with cystic fibrosis, RSV vaccine, Respiratory syncytial virus",
author = "Piedra, {Pedro A.} and Cron, {Stanley G.} and Alan Jewell and Nicole Hamblett and Ruth McBride and Palacio, {Melisa A.} and Richard Ginsberg and Oermann, {Christopher M.} and Hiatt, {Peter W.} and S. McColley and M. Bowman and D. Borowitz and R. Castile and K. McCoy and C. Prestige and Brown, {M. E.} and J. Stevens and W. Regelmann and C. Milla and Sammut, {Paul Henry} and Colombo, {John Louis} and J. Eisenberg and Murphy, {T. D.} and J. Finder and G. Kurland and G. Winnie and D. Orenstein and K. Voter and M. Light and Pian, {M. S.} and C. Harris and D. Stokes and R. Fink and C. Ren and J. Gorvoy and L. Varlotta and M. Dyson",
year = "2003",
month = "6",
day = "2",
doi = "10.1016/S0264-410X(03)00098-7",
language = "English (US)",
volume = "21",
pages = "2448--2460",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "19-20",

}

TY - JOUR

T1 - Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus

T2 - A multi-center trial in children with cystic fibrosis

AU - Piedra, Pedro A.

AU - Cron, Stanley G.

AU - Jewell, Alan

AU - Hamblett, Nicole

AU - McBride, Ruth

AU - Palacio, Melisa A.

AU - Ginsberg, Richard

AU - Oermann, Christopher M.

AU - Hiatt, Peter W.

AU - McColley, S.

AU - Bowman, M.

AU - Borowitz, D.

AU - Castile, R.

AU - McCoy, K.

AU - Prestige, C.

AU - Brown, M. E.

AU - Stevens, J.

AU - Regelmann, W.

AU - Milla, C.

AU - Sammut, Paul Henry

AU - Colombo, John Louis

AU - Eisenberg, J.

AU - Murphy, T. D.

AU - Finder, J.

AU - Kurland, G.

AU - Winnie, G.

AU - Orenstein, D.

AU - Voter, K.

AU - Light, M.

AU - Pian, M. S.

AU - Harris, C.

AU - Stokes, D.

AU - Fink, R.

AU - Ren, C.

AU - Gorvoy, J.

AU - Varlotta, L.

AU - Dyson, M.

PY - 2003/6/2

Y1 - 2003/6/2

N2 - 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.

AB - 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.

KW - Children with cystic fibrosis

KW - RSV vaccine

KW - Respiratory syncytial virus

UR - http://www.scopus.com/inward/record.url?scp=12444294423&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=12444294423&partnerID=8YFLogxK

U2 - 10.1016/S0264-410X(03)00098-7

DO - 10.1016/S0264-410X(03)00098-7

M3 - Article

C2 - 12744878

AN - SCOPUS:12444294423

VL - 21

SP - 2448

EP - 2460

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 19-20

ER -