title: High stability of yellow fever 17D-204 vaccine: a 12-year restrospective analysis of large-scale production.
abstract: We have retrospectively analyzed 12 bulk lots of yellow fever vaccine Stamaril, produced between 1990 and 2002 and prepared from the same seed lot that has been in continuous use since 1990. All vaccine batches displayed identical genome sequence. Only four nucleotide substitutions were observed, compared to previously published sequence, with no incidence at amino-acid level. Fine analysis of viral plaque size distribution was used as an additional marker for genetic stability and demonstrated a remarkable homogeneity of the viral population. The total virus load, measured by qRT-PCR, was also homogeneous pointing out reproducibility of the vaccine production process. Mice inoculated intracerebrally with the different bulks exhibited a similar average survival time, and ratio between in vitro potency and mouse LD(50) titers remained constant from batch-to-batch. Taken together, these data demonstrate the genetic stability of the strain at mass production level over a period of 12 years and reinforce the generally admitted idea of the safety of YF17D-based vaccines.
authors.affiliation: Research Department, Sanofi Pasteur, Marcy-l'Etoile, France. veronique.barban@sanofipasteur.com
authors.forename: V
authors.initials: V
authors.lastname: Barban
authors.forename: Y
authors.initials: Y
authors.lastname: Girerd
authors.forename: M
authors.initials: M
authors.lastname: Aguirre
authors.forename: S
authors.initials: S
authors.lastname: Gulia
authors.forename: F
authors.initials: F
authors.lastname: Pétiard
authors.forename: P
authors.initials: P
authors.lastname: Riou
authors.forename: B
authors.initials: B
authors.lastname: Barrere
authors.forename: J
authors.initials: J
authors.lastname: Lang
mesh_terms: D000818:Animals; D001483:Base Sequence; D002522:Chlorocebus aethiops; D004355:Drug Stability; D005260:Female; D051379:Mice; D012189:Retrospective Studies; D014709:Vero Cells; D010948:Viral Plaque Assay; D015004:Yellow Fever / Q000517:prevention & control; D022341:Yellow Fever Vaccine / Q000737:chemistry* / Q000235:genetics / Q000276:immunology / Q000494:pharmacology*
chemical_list: D022341:Yellow Fever Vaccine