Clinical trials of safety and immunogenicity of inactived and purifies rabies vaccine in healthy subjects

At the beginning of the clinical trial, four hundred sixty students in Vete rinary Medicine (220 in Belgium and 240 in France) were primovaccinated (0, 7 and 28 schedule) and received a booster one year later with three batche s of chromatography purified rabies vaccine produced on Vero cells (CPRV). All immune responses induced by both primary and secondary vaccinations wer e higher than the threshold of protection (0,5 International Unit / mi of s erum) and significant difference in the immune response was observed with t he three vaccine batches used, As far as the safety is concerned, local or systemic reactogenicity was generally mild, Neither severe immediate reacti on nor serious adverse event was reported following the vaccine administrat ion, Local reactions consisted of pain at the injection site, observed in 6 0% and 53% of the subjects following the priming and the booster respective ly. Pain occurred most often within 24 hours following vaccine injection an d generally lasted for 24-48 hours. The incidence of other local reactions never exceeded 9,8%. Systemic reactions were generally mild to moderate, co nsisting of gastro-intestinal troubles and dizziness. The percentage of ind ividuals showing at least one systemic reactivity symptom varied from 20% a fter primary vaccination to approximately 15 % after booster injection. No significant difference was observed in the frequency of local and systemic reactions related to the number of injections or to the vaccine batch. In c onclusion, we attest both the immunogenicity and safety of rabies immunizat ion with CPRV vaccine in this trial.