Considerations for hepatitis B as part of a combination vaccine

Background. In 1991 the Advisory Committee on Immunization Practices (ACIP) developed a comprehensive strategy to eliminate the transmission of hepatitis B virus in the United States, which includes immunization of all infants. Today, as the number of recommended childhood vaccinations increases, combination vaccines are needed to simplify the immunization schedule and improve coverage levels. Methods. A review of the literature was performed to determine the considerations that should be taken when hepatitis B virus vaccine (HepB) is included as part of a combination vaccine. Results. A combination vaccine that incorporates HepB and other routine infant vaccine antigens has been developed for administration at 2, 4 and 6 months of age. Clinical studies have demonstrated that administration of HepB, either as a monovalent or combination vaccine at 2,4 and 6 months of age, induces a seroprotective immune response similar to that achieved with monovalent HepB administered at 0, 1 and 6 months of age. In addition the combination vaccine results in similar or fewer adverse reactions compared with separate administration of its components. Infants given a dose of monovalent HepB at birth will receive a total of four doses of HepB when the combination is used. The extra dose of HepB has not led to increased adverse reactions. Conclusions. A HepB-containing combination vaccine administered at 2, 4 and 6 months of age is as safe and immunogenic as separate administration of its components and will help simplify the childhood immunization schedule.