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. 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

Pediatrics - Pulmonary, Allergy

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

86 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 (US)
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

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.

Keywords

Children with cystic fibrosis
RSV vaccine
Respiratory syncytial virus

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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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

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

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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.",

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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",

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. ",

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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.

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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.

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

Abstract

Bibliographical note

Keywords

UN SDGs

Access

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