Abstract
Inactivated, wild-type foot-and-mouth disease virus (FMDV) vaccines are currently used to control FMD around the world. These traditional FMD vaccines are produced using large quantities of infectious, virulent, wild-type FMD viruses, with the associated risk of virus escape from manufacturing facilities or incomplete inactivation during the vaccine formulation process. While higher quality vaccines produced from wild-type FMDV are processed to reduce non-structural antigens, there is still a risk that small amounts of non-structural proteins may be present in the final product. A novel, antigenically marked FMD-LL3B3D vaccine platform under development by Zoetis, Inc. and the USDA-ARS, consists of a highly attenuated virus platform containing negative antigenic markers in the conserved non-structural proteins 3Dpol and 3B that render resultant vaccines fully DIVA compatible. This vaccine platform allows for the easy exchange of capsid coding sequences to create serotype-specific vaccines. Here we demonstrate the efficacy of the inactivated FMD-LL3B3D-A24 Cruzeiro vaccine in cattle against wild-type challenge with A24 Cruzerio. A proprietary adjuvant system was used to formulate the vaccines that conferred effective protection at low doses while maintaining the DIVA compatibility. In contrast to wild-type FMDV, the recombinant FMD-LL3B3D mutant viruses have been shown to induce no clinical signs of FMD and no shedding of virus in cattle or pigs when inoculated as a live virus. The FMD-LL3B3D vaccine platform, currently undergoing development in the US, provides opportunities for safer vaccine production with full DIVA compatibility in support of global FMDV control and eradication initiatives.
Highlights
Foot and Mouth Disease Virus (FMDV) is the causative agent of a highly contagious disease that affects pigs, cattle, sheep, goats, buffalos, and other cloven-hoofed animals
We describe protective immune responses in cattle and differentiating infected from vaccinated animals (DIVA) capabilities after vaccination with the novel FMD-LL3B3D A24 Cruzeiro antigen formulated with a proprietary adjuvant
In contrast to the conventional vaccines produced with wildtype FMD viruses, the recombinant FMDV-LL3B3D platform vaccine viruses are fully attenuated as they induce no clinical signs of FMD and no shedding of virus in cattle or pigs when inoculated as a live virus (35,36, Pflaum, in preparation)
Summary
Foot and Mouth Disease Virus (FMDV) is the causative agent of a highly contagious disease that affects pigs, cattle, sheep, goats, buffalos, and other cloven-hoofed animals. Current U.S law (21 U.S Code § 113A) states that no live virus of foot-and-mouth disease may be introduced for any purpose into any part of the mainland of the United States These U.S regulations and restrictions create challenges for FMDV research along with the discovery, development, and manufacture of FMD vaccines. In contrast to the conventional vaccines produced with wildtype FMD viruses, the recombinant FMDV-LL3B3D platform vaccine viruses are fully attenuated as they induce no clinical signs of FMD and no shedding of virus in cattle or pigs when inoculated as a live virus (35,36, Pflaum, in preparation) As a result, this vaccine platform may use existing FMD vaccine manufacturing technology without the concerns associated with current FMD vaccine production where the risk of wild-type virus escape from the manufacturing site may cause an FMD. We will discuss the preliminary vaccine safety and efficacy results and assessment of the DIVA compatibility
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