The world has watched the emergence of numerous animal viruses that may threaten animal health which were added to the perpetual growing list of animal pathogens. This emergence drew the attention of the experts and animal health groups to the fact that it has become necessary to work on vaccine development. The current review aims to explore the perspective vaccines for emerging viral diseases in farm animals. This aim was fulfilled by focusing on modern technologies as well as next generation vaccines that have been introduced in the field of vaccines, either in clinical developments pending approval, or have already come to light and have been applied to animals with acceptable results such as viral-vectored vaccines, viruslike particles, and messenger RNA-based platforms. Besides, it shed the light on the importance of differentiation of infected from vaccinated animals technology in eradication programs of emerging viral diseases. The new science of nanomaterials was explored to elucidate its role in vaccinology. Finally, the role of Bioinformatics or Vaccinomics and its assist in vaccine designing and developments were discussed. The reviewing of the published manuscripts concluded that the use of conventional vaccines is considered an out-of-date approach in eliminating emerging diseases. However, these types of vaccines are considered the suitable plan especially in countries with few resources and capabilities. Piloted vaccines that rely on genetic-based technologies with continuous analyses of current viruses should be the aim of future vaccinology. Smart genomics of emerging viruses will be the gateway to choosing appropriate vaccines, regardless of the evolutionary rates of viruses.

Purpose: The key objective of this study was to formulate a local combined inactivated gel adjuvanted vaccine containing bovine viral diarrhea virus (BVDV)-1, BVDV-2 viruses and Clostridium perfringens type A toxoid. The study evaluated its ability to enhance protective active immune response in camels’ calves against these infectious pathogens under field conditions. Materials and Methods: The local BVDV cytopathic strains and a local strain of toxigenic C. perfringens type A were used in vaccines formulation. Vaccines A and B were monovalent vaccines against C. perfringens and both strains of BVDVs, respectively. While the vaccine C was the combined vaccine used against the three agents. All vaccines were adjuvanted with Montanide gel. Sterility, safety, and potency tests were applied on the formulated vaccines. Virus neutralization and toxin anti-toxin neutralization tests were used to evaluate the immune responses. Results: Both monovalent (vaccine A) and combined vaccines (vaccine C) showed a protective level (4.5 and 3 IU/mL, respectively) against C. perfringens from the 2nd-week post-vaccination. The titer declined to 3 and 2 IU/mL, respectively at the 5th-month post-vaccination. The titer against BVDV, the monovalent vaccine (vaccine B) reached the beak (1.95 IU/mL) at the 1st-month post-vaccination and lasted till 6th-month post-vaccination (0.92 and 0.94 IU/mL) for BVDV-1a and BVDV-2, respectively. Conclusion Vaccination of camels with the combined vaccine adjuvanted by Montanide gel containing C. perfringens type A toxoid and BVDV strains with 6-month intervals is recommended to protect camels safely and efficiently against such infections in the field.

Purpose: Bovine respiratory disease is a worldwide health concern in the feedlot cattle causing morbidity and mortality in young with major economic losses to the producer. Programs of vaccination are integral parts of preventive health programs. We aim to prepare and evaluate lyophilized combined inactivated viruses (bovine viral diarrhea virus [BVDV] genotypes 1 and 2, bovine herpes virus type 1.1 [BoHV-1.1], bovine parainfluenza-3 virus [BPI-3V], and bovine respiratory syncytial virus [BRSV]) vaccine using saponin as a solvent and adjuvant in cattle. Materials and Methods: Lyophilized Pneumo-5 vaccine was formulated to include the inactivated BVDV genotypes 1 and 2, BoHV-1.1, BPI-3V, and BRSV. The saponin solution was used as an adjuvant and solvent. The prepared vaccines were adjusted to contain 1- and 1.5-mg saponin/dose. It was evaluated for its sterility, safety, and potency in mice and calves. The antibody titers in vaccinated calves were measured by virus neutralization test and enzymelinked immunosorbent assay (ELISA). Results: The Pneumo-5 vaccine was found to be free from any contaminants and safe in mice. Meanwhile, the vaccine showed safety in calves which inoculated intramuscularly with the double dose of the vaccines. The overall immune response reached its peak in the 2ndmonth post-vaccination. The vaccine contained saponin 1.5 mg/dose reached its antibodies peak in the 4th-week post-vaccination. All groups of vaccinated calves with both concentrations of the saponin did not show statistical significance in antibody titers measured by serum neutralization test and/or ELISA. Conclusion The prepared vaccine, namely Pneumo-5, and adjuvanted with either 1 or 1.5 mg/dose saponin was proved safe and potent for effectual protection of calves against BVDV genotypes 1 and 2, BoHV-1.1, BPI-3V, and BRSV.

Purpose: Bovine respiratory disease is a worldwide health concern in the feedlot cattle causing morbidity and mortality in young with major economic losses to the producer. Programs of vaccination are integral parts of preventive health programs. We aim to prepare and evaluate lyophilized combined inactivated viruses (bovine viral diarrhea virus [BVDV] genotypes 1 and 2, bovine herpes virus type 1.1 [BoHV-1.1], bovine parainfluenza-3 virus [BPI-3V], and bovine respiratory syncytial virus [BRSV]) vaccine using saponin as a solvent and adjuvant in cattle. Materials and Methods: Lyophilized Pneumo-5 vaccine was formulated to include the inactivated BVDV genotypes 1 and 2, BoHV-1.1, BPI-3V, and BRSV. The saponin solution was used as an adjuvant and solvent. The prepared vaccines were adjusted to contain 1- and 1.5-mg saponin/dose. It was evaluated for its sterility, safety, and potency in mice and calves. The antibody titers in vaccinated calves were measured by virus neutralization test and enzymelinked immunosorbent assay (ELISA). Results: The Pneumo-5 vaccine was found to be free from any contaminants and safe in mice. Meanwhile, the vaccine showed safety in calves which inoculated intramuscularly with the double dose of the vaccines. The overall immune response reached its peak in the 2ndmonth post-vaccination. The vaccine contained saponin 1.5 mg/dose reached its antibodies peak in the 4th-week post-vaccination. All groups of vaccinated calves with both concentrations of the saponin did not show statistical significance in antibody titers measured by serum neutralization test and/or ELISA. Conclusion The prepared vaccine, namely Pneumo-5, and adjuvanted with either 1 or 1.5 mg/dose saponin was proved safe and potent for effectual protection of calves against BVDV genotypes 1 and 2, BoHV-1.1, BPI-3V, and BRSV.

Background/Aims: PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD). Methods: OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients. Results: In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment. Conclusions In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)

Background/Aims: Oral EDP-514 is a potent core protein inhibitor of hepatitis B virus (HBV) replication, which produced a >4-log viral load reduction in HBV-infected chimeric mice with human liver cells. This study evaluated the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in treatment-naive viremic patients with HBeAgpositive or -negative chronic HBV infection. Methods: Patients with HBsAg detectable at screening and at least 6 months previously were eligible. HBeAg-positive and -negative patients had a serum/plasma HBV DNA level ≥20,000 and ≥2,000 IU/mL, respectively. Twenty-five patients were randomized to EDP-514 200 (n=6), 400 (n=6) or 800 mg (n=7) or placebo (n=6) once daily for 28 days. Results: A dose-related increase in EDP-514 exposure (AUClast and Cmax) was observed across doses. At Day 28, mean reductions in HBV DNA were –2.9, –3.3, –3.5 and –0.2 log10 IU/mL with EDP-514 200 mg, 400 mg, 800 mg, and placebo groups, respectively. The corresponding mean change from baseline for HBV RNA levels was –2.9, –2.4, –2.0, and –0.02 log10 U/mL. No virologic failures were observed. No clinically meaningful changes from baseline were observed for HBsAg, HBeAg or HBcrAg. Nine patients reported treatment emergent adverse events of mild or moderate severity with no discontinuations, serious AEs or deaths. Conclusions In treatment-naïve viremic patients, oral EDP-514 was generally safe and well-tolerated, displayed PK profile supportive of once-daily dosing, and markedly reduced HBV DNA and HBV RNA.