Shelf Life and Accelerated Stability Studies of Porvac®, a Marker Subunit Vaccine Against Classical Swine Fever

Y. Sordo-Puga¹ , T. Sardina-González² , I. Sosa-Testé³ , P. Naranjo-Valdéz⁴ , M.P. Rodríguez-Moltó⁵ , E. Santana-Rodríguez⁶ , M. Vargas-Hernández⁷ , M.K. Méndez-Orta⁸ , D. Pérez-Pérez⁹ , A. Oliva-Cárdenas¹⁰ , A. Magdariaga-Figuerola¹¹ , W. Pena-Guimaraes¹² , N. González-Fernández¹³ , E. Bover-Fuentes¹⁴ , R. Segura-Silva¹⁵ , C.A. Duarte¹⁶ , M.F. Suárez-Pedroso¹⁷

Section:Research Paper, Product Type: Journal-Paper
Vol.9 , Issue.3 , pp.16-24, Jun-2022

Online published on Jun 30, 2022

Copyright © Y. Sordo-Puga, T. Sardina-González, I. Sosa-Testé, P. Naranjo-Valdéz, M.P. Rodríguez-Moltó, E. Santana-Rodríguez, M. Vargas-Hernández, M.K. Méndez-Orta, D. Pérez-Pérez, A. Oliva-Cárdenas, A. Magdariaga-Figuerola, W. Pena-Guimaraes, N. González-Fernández, E. Bover-Fuentes, R. Segura-Silva, C.A. Duarte, M.F. Suárez-Pedroso . This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
 

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Abstract :
Porvac® subunit vaccine, based on the chimeric E2-CD14 antigen, induces a very early protective immune response against classical swine fever. It is an attractive alternative for modified live vaccines (MLV) in endemic areas. One of the main advantages of subunit vaccines over MLV, especially for low-income settings, is their better thermal stability. This investigation aimed to assess both, shelf life, and accelerated stability of Porvac®. Three batches of Porvac® were stored at 2 - 8 °C for 36 months and their organoleptic properties, rheology, droplet size, the mechanical and thermal stability of the emulsion, immunogenicity, and capacity to confer protection in piglets were evaluated at different time points. A short-term accelerated stability study was also conducted by incubating three different batches at 37 °C for 7 days. Finally, a one-month accelerated stability experiment was conducted with a single vaccine batch. The vaccine maintained its organoleptic properties and droplet size up to at least 36 and 24 months, respectively. The emulsion was mechanically and thermally stable up to at least 9 months, and its rheological parameters remained below the acceptance limits for up to at least 24 months. All vaccinated swine developed neutralizing antibody titers ? 1:1000 at 28 days post-vaccination and were fully protected from the viral challenge at all the time points evaluated. In summary, Porvac® retains the capacity to induce protective neutralizing antibodies after 36 months of shell storage at 2 - 8 °C, and one month at 37 °C.

Key-Words / Index Term :
NPLA; classical swine fever; virus, vaccine, stability, Montanide

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