title: Comparative pre-clinical and clinical experience with oral polio vaccine produced on MRC-5 cells or on primary monkey kidney cells.
abstract: The need to avoid using primates has prompted the replacement of primary monkey kidney cells (PMKC) as a substrate for oral polio vaccine (OPV) production. Here, we report on OPV produced on MRC-5 cells using an industrial process capable of producing over 1 billion doses. All serotypes produced on MRC-5 cells proved satisfactory in the monkey and transgenic mice neurovirulence tests. All the type 3 MRC-5 lots tested by Mutant Analysis by PCR and Restriction Enzyme Cleavage (MAPREC) had a 472-C content below the acceptable limit and similar to that of PMKC derived lots. The safety/reactogenicity and immunogenicity profiles following vaccination in infants and children were similar for OPV MRC-5 and OPV PMKC vaccine lots. Excretion rates and prevalence of revertants for the three serotypes following vaccination were also similar for both vaccines. These data support the use of MRC-5 cells as an alternative to PMKC for OPV production.
authors.affiliation: Slovak National Commission for Certification of the Polio Eradication, Partizanska 3261, SK 05801 Poprad, Slovakia.
authors.forename: Viktor
authors.initials: V
authors.lastname: Prikazsky
authors.forename: Geert
authors.initials: G
authors.lastname: Leroux-Roels
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.forename: Assad
authors.initials: A
authors.lastname: Safary
authors.forename: Brigitte
authors.initials: B
authors.lastname: Colau
authors.forename: Michel
authors.initials: M
authors.lastname: Duchene
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D002478:Cells, Cultured / Q000821:virology*; D002648:Child; D000882:Haplorhini; D006801:Humans; D007668:Kidney / Q000166:cytology; D017955:Poliovirus; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage / Q000009:adverse effects / Q000096:biosynthesis / Q000276:immunology*; D012449:Safety
chemical_list: D011055:Poliovirus Vaccine, Oral