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

SERAFINO JUAN; JENSEN OSCAR; JOSE LA TORRE; THELMA VERONICA POGGIO

Mexico

Congreso; 13 th INTERNATIONAL CONGRESS OF PARASITOLOGY; 2014

Latin American Federation of Parasitology

Bioequivalence studycomparing the first recombinant vaccine against Hydatidosis produced inArgentina and the Australian formulation.SerafinoJuan1,Jensen Oscar2, Lightowlers Marshall 3, Heath David 4,La Torre Jose1, Poggio Thelma11CEVAN-ICT Milstein, CONICET- 2 Secretaría de Salud, Chubut?Argentina.3University of Melbourne- Australia. 4 AgResearch-New Zealand BACKGROUND: The EG95 recombinant vaccine has beendeveloped for prevention of hydatidosis in intermediate host (Heath-Ligthtowlers,1995). InArgentina, procedures have been incorporated to adjust the recombinant EG95protein expression and the selection of adjuvant formulations. Subsequently,Providean Hidatil EG95 was approved as the first recombinant vaccine for veterinaryuse in 2011.Theefficacy of Providean Hidatil EG95 was compared with the australian formulationand the bioequivalence was demonstrated in a field trial carried out in Chubutsince 2009. METHODS: Three groups of sheep (n=10) wereimmunized subcutaneously on day 0-30 and boostered 465-1400 dpv. Group 1 wasimmunized with Providean Hidatil EG95 (50µg-EG95 plus Montanide ISA 70) andGroup 2 received the australian vaccine (50µg-Eg95 plus 1 mg QuilA). Controlsheep received no antigen. Total IgG titers against EG95 were testedindividually on day 0, 30, 45, 465, 730, 1000, 1300, 1400 and 1430 using avalidated ELISA. .RESULTS: Providean Hidatil EG95 induced hightiters of specific antibodies in sera from immunized sheep that persisted formore than one year after 2 dosis and  twoyears after booster on day 465. Furthermore, titers did not show significantdifferences with those elicited by the australian vaccine.  CONCLUSIONS: Theresults demonstrate that Providean Hidatil EG95 is bioequivalent to theaustralian vaccine. The correlation between EG95 titers and protection will bediscussed. Theproduction of the EG95 vaccine is a fact in our country. The vaccine was includedin the National Hydatid Control Programme as a new tool to protect intermediaryhosts.