Safety and immunogenicity in piglets of the vaccine candidate E2-CD154, a subunit vaccine against classical swine fever. Results from phase III clinical trial
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Abstract
E2-CD154 is a subunit vaccine candidate that has been proven to be safe and to protect piglets from classical swine fever (CSF). In this study, those previous findings were confirmed and extended to a larger number of animals in a phase III clinical trial conducted on two production farms in Pinar del Río province. All animals in both farms were vaccinated with two doses of E2-CD154 on days 0 and 21. The study extended up to 60 weeks. The vaccine was well tolerated in piglets between 15 and 28 days of life, with neither local nor systemic side effects documented. Immunized pregnant sows were capable of transmitting high levels of maternally-derived neutralizing antibodies (MDNAs) to their offspring (Unit A, geometric mean titer = 1:1295, minimum value 1:100 and Unit B geometric mean titer = 1:474, minimum value 1:150), well above the protection threshold (1:50). These high MDNA titers in the piglets did not interfere with the immunogenicity of the candidate. All vaccinated piglets evaluated at random (more than 10% of 2804 vaccinated) developed protective neutralizing antibody titers higher than 1:400 at the four time points analyzed (nine, 21, 41, and 44 weeks) in both farms. The results of this study confirm the safety, immunogenicity and robustness of this vaccine candidate in this sensitive pig category in the field.
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