Bioequivalence study comparing the first recombinant vaccine against Hydatidosis produced in Argentina and the Australian formulation.

POGGIO, THELMA VERÓNICA; JOSE LA TORRE; JUAN JAVIER SERAFINO; LIGHTOWLERS, MARSHALL W.; JENSEN OSCAR; DAVID HEATH

Ciudad de Mexico

Congreso; International Congress of Parasitology; 2014

National Council of Science and Technology (CONACYT) National Autonomous University of Mexico (UNAM) Bill and Melinda Gates Foundation

Bioequivalence study comparing the first recombinant vaccine against Hydatidosis produced in Argentina and the Australian formulation.Serafino Juan1, Jensen Oscar2, Lightowlers Marshall 3, Heath David 4, La Torre Jose1, Poggio Thelma11 CEVAN-ICT Milstein, CONICET- 2 Secretaría de Salud, Chubut?Argentina.3 University of Melbourne- Australia. 4 AgResearch-New ZealandBACKGROUND: The EG95 recombinant vaccine has been developed for prevention of hydatidosis in intermediate host (Heath-Ligthtowlers, 1995). In Argentina, procedures have been incorporated to adjust the recombinant EG95 protein expression and the selection of adjuvant formulations. Subsequently, Providean Hidatil EG95 was approved as the first recombinant vaccine for veterinary use in 2011.The efficacy of Providean Hidatil EG95 was compared with the australian formulation and the bioequivalence was demonstrated in a field trial carried out in Chubut since 2009.METHODS: Three groups of sheep (n=10) were immunized subcutaneously on day 0-30 and boostered 465-1400 dpv. Group 1 was immunized with Providean Hidatil EG95 (50µg-EG95 plus Montanide ISA 70) and Group 2 received the australian vaccine (50µg-Eg95 plus 1 mg QuilA). Control sheep received no antigen. Total IgG titers against EG95 were tested individually on day 0, 30, 45, 465, 730, 1000, 1300, 1400 and 1430 using a validated ELISA. . RESULTS: Providean Hidatil EG95 induced high titers of specific antibodies in sera from immunized sheep that persisted for more than one year after 2 dosis and two years after booster on day 465. Furthermore, titers did not show significant differences with those elicited by the australian vaccine. CONCLUSIONS: The results demonstrate that Providean Hidatil EG95 is bioequivalent to the australian vaccine. The correlation between EG95 titers and protection will be discussed. The production of the EG95 vaccine is a fact in our country. The vaccine was included in the National Hydatid Control Programme as a new tool to protect intermediary hosts.