Immunogenicity of a new purified fusion protein vaccine to respiratory syncytial virus: a multi-center trial in children with cystic fibrosis.
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 0.37 log2 per month, respectively. The PFP-3 vaccine-induced a robust immune response that lasted throughout the RSV season.
Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX 77030, USA. ppiedra@bcm.tmc.edu
Pedro A
PA
Piedra
Stanley G
SG
Cron
Alan
A
Jewell
Nicole
N
Hamblett
Ruth
R
McBride
Melisa A
MA
Palacio
Richard
R
Ginsberg
Christopher M
CM
Oermann
Peter W
PW
Hiatt
D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000150:complications / Q000276:immunology*; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D018579:Patient Selection; D011993:Recombinant Fusion Proteins / Q000276:immunology / Q000627:therapeutic use; D018357:Respiratory Syncytial Virus Infections / Q000453:epidemiology / Q000276:immunology* / Q000517:prevention & control; D012136:Respiratory Syncytial Viruses / Q000276:immunology / Q000302:isolation & purification; D012621:Seasons; D014614:Vaccines, Synthetic / Q000276:immunology* / Q000627:therapeutic use; D014765:Viral Vaccines / Q000276:immunology* / Q000627:therapeutic use
D000276:Adjuvants, Immunologic; D011993:Recombinant Fusion Proteins; D014614:Vaccines, Synthetic; D014765:Viral Vaccines