Q fever is a zoonotic disease caused by C. burnettii, an obligatory intracellular bacterium that produces a highly resistant “spore-like” form1,2. Q fever affects humans and animals and it is endemic worldwide3 except New-Zealand4 but its prevalence is underestimated5. However, as diagnostic methods became more specific and easier to use, increasing number of cases are reported (e.g. acute human cases Bulgaria and The Netherlands). The shedding of C. burnettii by ruminants is considered as main source of the human infections6. The vaccination is an effective tool to control the disease.
The protective antigen of C. burnetii is the full-length phase I LPS7,8,9. According to the statement of OIE “only vaccines containing or prepared from phase I C. burnetii should be considered protective”. Two marketed vaccines in the world are known that consist of exclusively phase I C. burnetii: Q-Vax (CSL, Australia) for human and Coxevac (Ceva, France) for veterinary applications.
The production of phase I antigen-based vaccine is performed in GMP biosafety-level 3 area. The process is rather complex, composed of bacteria cultivation on embryonated egg yolk sac, harvest, several downstream steps including inactivation and chemical extraction. The process is strictly controlled through specific ELISA methods to differentiate between phase I and II antigens, and to quantify antigen and egg-derived ballast protein contents for formulation.
The efficacy of the Q fever vaccine was demonstrated by vaccination and subsequent heterologous challenge in target species. The two main parameters to be assessed are the drastic decrease of abortion rate as well as the drop in the shedding of the bacterium10. A marketing authorisation (under exceptional circumstances) was obtained in September 2010 by Ceva in all EU member countries.
Coxevac vaccine combined with other complementary prophylactic measures has been successfully used in many EU countries to prevent Q fever in ruminants11,12,13,14.