Field study of the safety, immunogenicity, and efficacy of an inactivated equine rotavirus vaccine

Objective - To determine safety, immunogenicity, and efficacy of an inactivated equine rotavirus vaccine. Design - Prospective randomized controlled trial. Animals - 316 pregnant Thoroughbred mares during the first year of the study and 311 during the second year. Procedure - During the first year, mares received 3 doses of vaccine or placebo. IM, at 8, 9, and 10 months of gestation. Serum neutralizing antibody titers were measured before vaccination and 1 and 35 days after foaling. Antibody titers were measured in foals 1, 7, 35, 60, 90, and 120 days after birth. During the second year, mares that had been vaccinated the previous year received a single booster dose of vaccine approximately 1 month prior to parturition. Mares that had received the placebo the previous year and mares new to the study received 3 doses of vaccine or placebo. Serum neutralizing antibody titers were measured in samples taken from mares approximately 1 day after foaling and from foals approximately 1 and 60 days after birth. Results - Adverse reactions were not observed. Antibody titers were significantly increased at the time of foaling and 35 days after foaling in vaccinated, compared with control, mares and for 90 days after birth in foals born to vaccinated, compared with foals born to control, mares. Incidence of rotaviral diarrhea was lower in foals born to vaccinated, compared with foals born to control, mares, but the difference was not significant. Clinical Implications - Results suggest that the equine rotavirus vaccine is safe and immunogenic and that reasonable efficacy under field conditions can be expected.