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Abstract: The hepatitis B virus (HBV) core and surface antigens are potent immunogens in animal models and humans. They have been used in vaccine studies for prevention or therapy of HBV diseases and also as carrier molecules in new developments. In this study we explored the nasal immunogenicity of two different variants of the recombinant complete nucleocapsid (HBcAg) as well as their adjuvant effect on hepatitis B surface antigen (HBsAg). To characterize the immune response, the serum IgG antibody response was tested during one year against both antigens, and the serum and vaginal secretions were tested for recognition of linear epitopes of HBcAg for both HBcAg variants. The results obtained evidenced that the intranasal immunogenicity of both HBcAg variants was similar and high, developing early and long lasting IgG responses. A similar recognition pattern to all sera and vaginal washes samples was generated by the two variants of HBcAg, also similar to a pool of human anti-HBcAg positive sera. A synergistic effect in the enhancement of the immunogenicity for both antigens was evidenced in the combined formulation after nasal administration. Taken together, these results would be of interest in the design of more potent therapeutic and preventive vaccines complementing systemic and mucosal responses. [Copyright &y& Elsevier]

Abstract: The hepatitis B virus (HBV) core antigen (HBcAg) is a potent immunogen in animal models and humans and has been used as a carrier for several antigens; however, the mucosal immunogenicity of HBcAg has been poorly studied. In this study, we explored the immunogenicity and the immunoenhancing effect elicited by two different variants of the recombinant complete nucleocapside of HBV in mice by intranasal route. For this purpose, we used as co-administered antigen, the HBV surface protein (HBsAg) and the antibody response in sera was evaluated after each dose. To analyze the specificity of the generated antibody response, the recognition of lineal epitopes was evaluated on a cellulose membrane bearing 12mer peptides covering the HBcAg sequence. The obtained results evidenced that the intranasal immunogenicity of both variants of HBcAg was similar and high, developing early responses of IgG. The immunoenhancing effect on the HBsAg-specific antibody response was also similar for both variants. The results of the recognition of lineal epitopes study evidenced a similar recognition pattern to all sera and vaginal lavages samples generated by the immunization of mice with the two variants of HBcAg, and also similar to a pool of human anti-HBcAg positive sera samples. [Copyright &y& Elsevier]