Safety and immunogenicity of a new formulation of an inactivated hepatitis A vaccine

Vaccine. 1999 Apr 9;17(15-16):1919-25. doi: 10.1016/s0264-410x(98)00461-7.

Abstract

The safety and immunogenicity of a new formulation of the inactivated hepatitis A vaccine, Avaxim, was evaluated in 189 children, aged 18 months to 15 years in a monocentric, open trial. Two vaccinations were given six months apart. Enrollment was balanced within three age groups: 18 months to 3 years, 4-8 years and 9-15 years. Antibody titers were measured blindly by an independent laboratory using a modified radioimmunoassay. Two weeks after the first dose, seroconversion was achieved by 94.6, 94.3 and 96.4% of initially HAV-seronegative subjects (antibody titre <20 mIU/ml) in each age group (youngest to oldest, respectively), with corresponding geometric mean titre concentrations (GMC) of 72.2, 54.3 and 47.1 mIU/ml. Just before the booster dose, the seroconversion rate was 100% in all groups, and the corresponding GMC values were 163, 169 and 111 mIU/ml. All groups included, a 22.6-fold rise in GMC from prebooster levels was observed four weeks after the booster dose. An explanatory analysis suggested a tendency for higher antibody levels in younger children at all vaccination time points. Local reactions were noted in 18.2% of the vaccinees after the first dose and in 8.5% after the booster dose. The rates of systemic reactions were 23.8% after the first dose and 11.4% after the booster dose. Overall, this trial demonstrated the good safety and immunogenicity profile of this vaccine in children aged 18 months to 15 years of age.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Female
  • Hepatitis A Antibodies
  • Hepatitis A Vaccines
  • Hepatitis Antibodies / blood*
  • Hepatovirus / immunology*
  • Humans
  • Immunization, Secondary
  • Infant
  • Male
  • Radioimmunoassay
  • Single-Blind Method
  • Vaccines, Inactivated / administration & dosage
  • Vaccines, Inactivated / adverse effects
  • Vaccines, Inactivated / immunology
  • Viral Hepatitis Vaccines / administration & dosage
  • Viral Hepatitis Vaccines / adverse effects*
  • Viral Hepatitis Vaccines / immunology*

Substances

  • Hepatitis A Antibodies
  • Hepatitis A Vaccines
  • Hepatitis Antibodies
  • Vaccines, Inactivated
  • Viral Hepatitis Vaccines