Neutralizing antibodies as a correlate of protection against classical swine fever in Porvac® vaccinated pigs

Abstract

Porvac is a classical swine fever (CSF) subunit vaccine. It is safe and induces a robust neutralizing antibody response, sterilizing immunity, and early protection, and it prevents vertical transmission in pregnant sows. The methodology to approve Porvac batches is a challenging experiment in pigs with a virulent CSF virus strain. However, there is an ethical reason to reduce, at minimum, the use of animals in these lethal experiments. The knowledge indicates that neutralizing antibody titers in the blood could be a good correlate of protection. The results of 22 challenge experiments involving 116 Porvac vaccinated and 38 unvaccinated animals were analyzed. All vaccinated animals remained free from CSF clinical signs and pathological lesions and were negative for viral isolation after the challenge. In contrast, all unvaccinated pigs developed clinical and pathological signs of the disease and had to be euthanized eight days post-challenge. All vaccinated pigs exhibited high neutralizing antibody titers, with a geometric mean value of 1: 5153. The lower titer registered was 1: 800. A complete correspondence between neutralizing antibody titers and protection was demonstrated. These results support substituting the viral challenge test for the neutralizing peroxidase-linked assay in the release of Porvac® batches. Keywords. Classical swine fever; virus; subunit vaccine; viral challenge; neutralizing antibodies