Abstract

ACOSTA ACOSTA, Josué  et al. Safety study, phase I clinical trial, of the antihepatitis B hyperimmune gammaglobulin administered in one site and together with the HbasAg recombinant vaccine: preliminary results. Rev Cubana Invest Bioméd [online]. 2004, vol.23, n.1, pp. 38-42. ISSN 1561-3011.

The vaccine preparation of the recombinant HbsAg vaccine with the hyperimmune antihepatitis B gammaglobulin (passive immunization of antibodies) was used and the safety (phase I of clinical trials) of gammaglobulin was evaluated on being administered in one site together with the antihepatitis B vaccine. 25 sound volunteers aged 20-50 were immunized with the vaccine preparation of hyperimmune gammaglobulin (200 UI/mL) and with antihepatitis B vaccine (20 g HbsAg/dose), which were administered in only one site and as a whole in the deltoid region in the time 0-1 month within the immunization scheme of the vaccine (0-1-3 months). No undesirable local or systemic effects were detected in any of the participants. The inocuity observed makes possible to go on with further phases of clinical studies

Keywords : GAMMAGLOBULINS [immunology]; HEPATITIS B VIRUS [immunology]; HEPATITIS B/ [immunology]; HEPATITIS B [transmission]; CLINICAL TRIALS; VIRAL HEPATITIS VACCINES [therapeutic use].