title: Yellow fever vaccine: comparison of the neurovirulence of new 17D-204 Stamaril™ seed lots and RK 168-73 strain.
abstract: The neurovirulence of two new candidate 17D-204 Stamaril™ working seed lots and that of two reference preparations were compared. The Stamaril™ working seed lots have been used for more than twenty years for the manufacturing of vaccines of acceptable safety and efficacy. The preparation designated RK 168-73 and provided by the Robert Koch Institute was used as a reference. It was confirmed that RK 168-73 strain was not a good virus control in our study because it has a very low neurovirulence regarding both the clinical and histopathological scores in comparison with Stamaril™ strain and is not representative of a vaccine known to be satisfactory in use. The results were reinforced by the phenotypic characterization by plaque assay demonstrating that RK 168-73 was very different from the Stamaril™ vaccine, and by sequencing results showing 4 mutations between Stamaril™ and RK 168-73 viruses leading to amino acid differences in the NS4B and envelop proteins.
authors.affiliation: Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, France. Jean-Claude.Moulin@sanofipasteur.com
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Moulin
authors.forename: Jérémy
authors.initials: J
authors.lastname: Silvano
authors.forename: Véronique
authors.initials: V
authors.lastname: Barban
authors.forename: Patrice
authors.initials: P
authors.lastname: Riou
authors.forename: Caroline
authors.initials: C
authors.lastname: Allain
mesh_terms: D000818:Animals; D002522:Chlorocebus aethiops; D004252:DNA Mutational Analysis; D005260:Female; D051379:Mice; D009154:Mutation; D014709:Vero Cells; D017361:Viral Nonstructural Proteins / Q000235:genetics / Q000276:immunology; D022341:Yellow Fever Vaccine / Q000009:adverse effects / Q000235:genetics / Q000276:immunology / Q000494:pharmacology; D015005:Yellow fever virus / Q000235:genetics / Q000276:immunology
chemical_list: C080106:NS4A protein, flavivirus; D017361:Viral Nonstructural Proteins; D022341:Yellow Fever Vaccine
keywords: 17D-204 Stamaril™; CIT; Centre International de Toxicologie; Eur. Ph; European Pharmacopoeia; FNV; French neurotropic vaccine; IABS; International Association for Biologicals symposium; Neurovirulence; RK 168-73; Seeds; TRS; Technical report series; Vaccine characterization; WHO; WSL; World Health Organization; YEL-AND; YEL-AVD; YF; Yellow Fever Vaccine-Associated Neurotropic Disease; Yellow Fever Vaccine-Associated Viscerotropic Disease; Yellow fever vaccine; working seed lot; yellow fever