[Hepatitis B vaccine trial in healthy adults - an immunogenicity study (author's transl)].

The clinical and immunological response in healthy adults to active and passive - active immunization with a vaccine prepared from purified HBsAg (Merck Sharp and Dohme) in combination with a hepatitis B immune serum globulin (HBIG) were determined and compared with each other. The subjects were randomly assigned to one of three groups: group I received 3 doses of vaccine (20 micrograms per dose) at 0, 1 and 6 months, group II received in addition with the first dose of vaccine 3 ml of HBIG and group III received HBIG together with the first and the second doses of vaccine. No serious side effects were seen during the observation period. Antibody response was comparable in all three groups after 6 months, showing that the passive antibodies did not interfere with active antibody formation. Our results also prove the safety and efficacy of the hepatitis B vaccine and establish the feasibility of passive-active immunization.

RCT Entities:   Population Interventions Outcomes