Would an in vitro ELISA test be a suitable alternative potency method to the in vivo immunogenicity assay commonly used in the context of international Hepatitis A vaccines batch release?

Poirier, Bertrand; Variot, P; Delourme, Pauline; Maurin, J.; Morgeaux, Sylvie

doi:10.1016/j.vaccine.2009.12.006

Cited by 9 publications

(2 citation statements)

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“…Therefore, an in vitro approach based on the measurement of the antigen content of the vaccine as a surrogate marker of the PRN titer has been successfully applied for some viral vaccines in recent years. Hepatitis A vaccine (6), Hepatitis B vaccine (20,21), and Newcastle disease virus vaccine (22) have been verified by determining their antigen contents with ELISA procedures based on specific mAbs. Inactivated poliovirus vaccine was validated not only by its in vivo PRN titer but also, alternatively, in an in vitro assay that determined its antigen content (19).…”

Section: Discussionmentioning

confidence: 99%

“…Most biological products, such as vaccines, are complex mixtures that can differ from batch to batch. Thus, the content of the JEV target antigen in a vaccine seems to differ from one manufacturer to another (6). Therefore, a panel of potent and reduced‐potency batches was tested with both the in vivo potency assay in mice and an in vitro test to determine their antigen contents.…”

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confidence: 99%

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Development of an in vitro antigen‐detection test as an alternative method to the in vivo plaque reduction neutralization test for the quality control of Japanese encephalitis virus vaccine

Kim

et al. 2012

Microbiology and Immunology

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Japanese encephalitis virus (JEV) causes diseases that attack the human central nervous system. Traditionally, the quality control for JEV vaccines, in which the plaque reduction neutralization (PRN) titer is measured by the national control laboratories before the vaccine batches are marketed, has required laboratory animal testing. However, classical animal tests have inherent problems, including the very fact that animals are used, ethical issues, and the possibility of error. In this study, JEV antigen was measured in an in vitro assay to assess the feasibility of replacing in vivo assays that measure the PRN titers of JEV vaccines. We constructed a double‐sandwich enzyme‐linked immunosorbent assay (DS‐ELISA) that could detect JEV envelope (E). Initially, monoclonal antibodies (mAbs) directed against the JEV E protein were generated and characterized. We isolated 18 mAbs against JEV E protein, and most were the IgG1 or IgG2a isotype. The mAbs (5F15 and 7D71) were selected as the most suitable mAb pair to detect JEV E protein. DS‐ELISA with this pair detected as little as approximately 3 μg/mL JEV E protein and demonstrated a relationship between the amount of JEV E protein and the PRN titer. From these results, we surmise that this DS‐ELISA may be useful, not only in terms of measuring the amount of JEV E protein, but also as a substitute for the PRN test for JEV vaccine evaluation.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%