Evaluation of safety, potency and efficacy of an indigenous homologous Lumpy Skin Disease vaccine in Iran

Background To date, vaccination with a safe and effective homologous vaccine is the best choice for the prevention and control of lumpy skid disease (LSD) in endemic countries. Objective Evaluation of the safety, potency and efficacy of an indigenous homologous LSD vaccine (contains live attenuated Neethling strain) in “blinded for review”. Animals: 15 cross breed Holstein male cattle, aged 6 to 9 months without antibodies against LSD virus (LSDV). Methods Two case groups [receiving one dose of vaccine (n = 8) and ten doses of vaccine (n = 2)] and one control group (n = 5) were studied. Safety was evaluated by the clinical reaction score (CRS) index during the period of 21 days after vaccination. Potency was evaluated through Elisa and virus neutralization (VN) tests in the period of 21 days after vaccination. Efficacy was evaluated through CRS index in 14 days period after challenge with wild-type virus. Results In the safety evaluation, although the CRS index in the vaccinated groups was higher than the control group (P < .05), LSD signs were not observed in the vaccinated groups. In the potency evaluation, the studied vaccine in the vaccinated groups caused seropositivity compared to the control group (P < .05). In the efficacy evaluation, the studied vaccine in the vaccinated groups inhibited the occurrence of LSD signs following challenge with LSDV, compared to the control group (P < .05). Conclusion and Clinical Importance: In terms of safety, potency and efficacy, the studied vaccine is a suitable candidate for an evaluation study at the field level.