Immunogenicity and safety studies of an inactivated vaccine against Rift Valley fever.

Rift Valley fever (RVF) is an emerging transboundary, mosquito-borne, zoonotic viral disease caused by a single serotype of a virus belonging to the Phenuiviridae family (genus Phlebovirus). It is considered an important threat to both agriculture and public health in endemic areas, because the virus, transmitted by different mosquito genera, leads to abortions in susceptible animal hosts especially sheep, goat, cattle, and buffaloes, resulting in severe economic losses. Humans can also acquire the infection, and the major sources are represented by the direct contact with infected animal blood, aerosol, consumption of unpasteurized contaminated milk and the bite of infected mosquitoes. Actually, the EU territory does not seem to be exposed to an imminent risk of RVFV introduction, however, the recent outbreaks in a French overseas department and some cases detected in Turkey, Tunisia and Libya, raised the attention of the EU for a possible risk of introduction of infected vectors. Thus, there is an urgent need to develop new therapeutic and/or preventive drugs, such as vaccines. In our work, we studied the immunogenicity of an inactivated and adjuvanted vaccine produced using a Namibian field strain of RVF virus (RVFV). The vaccine object of this study was formulated with Montanide Pet Gel A, a polymer-based adjuvant that has been previously reported for its promising safety profile and for the capacity to elicit a strong immune response. The produced inactivated vaccine was tested on six sheep and the level of IgM and IgG after the immunization of animals was evaluated by a commercial competitive ELISA, in order to assess the immunogenicity profile of our vaccine and to evaluate its potential use, as an alternative to the attenuated vaccines commercially available, in case of Rift Valley fever epidemic disease on EU territory. Following the administration of the second dose, 35 days after the first one, all animals seroconverted.