Tu187 - Evaluation of the Vaccine Potential of a Cgmp Manufactured Vaccine for Clinical Development Against Lymphatic Filariasis

Abstract Text: We have cGMP manufactured a tetravalent fusion protein vaccine for Lymphatic Filariasis (LF), a tropical parasitic infection caused by the parasitic worms Wuchereria bancrofti, Brugia malayi, and Brugia timori. The chronic infection causes severe lymphatic edema in dependent regions associated with marked lymphatic pathology. Lymphatic Filariasis (LF) is the second leading cause of disability in the world, leading to severe stigma in affected patients. There are no vaccines available to control this infection. About 886 million people worldwide need protection from this disease. A tetravalent vaccine, rBmHAXT (∆cys), developed in our laboratory has completed all pre-clinical studies, product development, and cGMP manufacturing. The focus of this study was to compare the immunogenicity and vaccine efficacy of the cGMP manufactured rBmHAXT (∆cys) with our parent rBmHAXT (∆cys) protein in a jird model. . Following infection, the parasite develops into male and female worms in jirds. We immunized jirds with 15 μg of rBmHAXT (∆cys) or the parent protein along with an adjuvant AL019 (alum+GLE). Our results show that all the immunized jirds developed high titers (>1:80,000) of IgG antibodies and antigen-specific T cells. The vaccine-induced protection in GMP rBmHAXT (∆cys) immunized mice was highly significant and comparable to the parent protein. Thus, the cGMP-manufactured rBmHAXT (∆cys) vaccine retained the immunogenicity and vaccine potential of the parent molecule. These studies will advance the LF vaccine to the clinic.