Correlation between direct ELISA, single epitope-based inhibition ELISA and Pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine
2008
To monitor immune status during clinical trials and after vaccine registration, several assays have been developed to measure type-specific human papillomavirus (HPV) serum antibody levels. These include neutralization assays, single
epitope-based inhibition immunoassays, and direct enzyme-linked immunosorbent assays (ELISAs). Neutralization assays based on multiple
epitopesand independent of vaccine material are considered the ‘gold standard’ for unbiased assessment of the protective potential of vaccine-induced antibodies. However, their use in large clinical trials is challenging. Here, we compare both the direct ELISA and the single
epitope-based inhibition ELISA with the
pseudovirion-based neutralization assay (PBNA) for HPV-16/18 antibody responses in vaccinated women enrolled in trials of
Cervarix™, GSK's cervical
cancer vaccine. The direct ELISA, which is based on multiple
epitopes, was shown to have a higher degree of sensitivity and correlation with the PBNA when compared with...
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