Why the study?
Evaluating the potency of foot-and-mouth disease virus-like particle vaccines currently lacks in vitro tools.
Does the novel M8 liquid-phase blocking ELISA accurately assess the potency of foot-and-mouth disease virus-like particle vaccines in cattle and pigs?
Does the novel M8 liquid-phase blocking ELISA accurately assess the potency of foot-and-mouth disease virus-like particle vaccines in cattle and pigs?
The novel M8 liquid-phase blocking ELISA provides a reliable in vitro alternative to live-animal challenge trials for evaluating the potency of foot-and-mouth disease virus-like particle vaccines.
M8 LPBE may enable in vitro potency testing for FMD VLP vaccines; leaves open prospective validation before replacing challenge studies.
Potency tests for inactivated foot-and-mouth disease (FMD) vaccines involve either in vivo challenge trials in target animals or in vitro tests. However, evaluating potency of FMD virus-like particle (VLP) vaccines currently lack in vitro tools. We developed a liquid-phase blocking ELISA (LPBE) using a broadly neutralizing single-domain antibody (M8) and FMD VLPs to assess antibody titers in animals vaccinated with FMD serotype O VLPs. We utilized 505 negative sera and 32 sera of pigs infected or vaccinated with other viruses than FMDV to validate the M8 LPBE detection limit. The M8 LPBE was compared to virus neutralizing test and conventional LPBE using 338 sera from PD 50 potency tests in cattle and pigs. The results were analyzed using logistic models. The M8 LPBE showed superior correlation with protection, with an average titer of 1.7 log 10 corresponding to a potency of 3 PD 50 /dose.
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Li et al. (2025) studied this question.
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