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. Sammut; J. 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

doi: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

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. Sammut

J. 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

Pediatrics

University at Buffalo

Baylor College of Medicine
Axio Research Corporation
Pfizer
Children's Memorial Hospital
Children's Hospital Los Angeles
Nationwide Children’s Hospital
Children's Medical Center Dallas
Riley Hospital for Children
University of Minnesota Twin Cities
University of Nebraska Medical Center
Oregon Health and Science University
University of Pittsburgh
Children's Hospital at Strong
University of California at San Diego
Vanderbilt University
Children's National Medical Center
Stony Brook University
St. Christopher's Hospital for Children Philadelphia
Cook Children's Medical Center

Research output: Contribution to journal › Article › peer-review

89 Scopus citations

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 language	English
Pages (from-to)	2448-2460
Number of pages	13
Journal	Vaccine
Volume	21
Issue number	19-20
DOIs	https://doi.org/10.1016/S0264-410X(03)00098-7
State	Published - Jun 2 2003

Keywords

Children with cystic fibrosis
RSV vaccine
Respiratory syncytial virus

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

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Piedra, P. A., Cron, S. G., Jewell, A., Hamblett, N., McBride, R., Palacio, M. A., Ginsberg, R., Oermann, C. M., Hiatt, P. W., McColley, S., Bowman, M., Borowitz, D., Castile, R., McCoy, K., Prestige, C., Brown, M. E., Stevens, J., Regelmann, W., Milla, C., ... 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

@article{4f67ef5c2bef4da9bc52d5578e800c93,

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 P. Sammut and J. Colombo 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 = jun,

day = "2",

doi = "10.1016/S0264-410X(03)00098-7",

language = "English",

volume = "21",

pages = "2448--2460",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier Ltd.",

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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, P, Colombo, J, 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

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, P.

AU - Colombo, J.

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 - https://www.scopus.com/pages/publications/12444294423

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

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

M3 - Article

C2 - 12744878

SN - 0264-410X

VL - 21

SP - 2448

EP - 2460

JO - Vaccine

JF - Vaccine

IS - 19-20

ER -

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

Abstract

Keywords

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