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.

journal_name

Vaccine

journal_title

Vaccine

authors

Prikazsky V,Leroux-Roels G,Van Damme P,Safary A,Colau B,Duchene M

doi

10.1016/j.vaccine.2005.04.002

subject

Has Abstract

pub_date

2005-07-21 00:00:00

pages

4219-27

issue

33

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(05)00410-X

journal_volume

23

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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