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A combined vaccine against hepatitis A and B in children and adolescents
F Diaz-Mitoma1, B Law, J Parsons
1Children's Hospital of Eastern Ontario, Ottawa, Canada. diaz@CHEO.on.ca
Insights
A new combined pediatric vaccine for hepatitis A and hepatitis B is safe and effective in children aged 1 to 15 years. This combined vaccine shows high immunogenicity and good tolerability in pediatric populations.
Area of Science:
- Pediatric Vaccinology
- Hepatitis A and B Prevention
- Immunology
Background:
- Monocomponent vaccines for hepatitis A and B are safe and immunogenic in children.
- Evaluating combined vaccine formulations can streamline pediatric immunization schedules.
Purpose of the Study:
- To assess the safety and immunogenicity of a combined hepatitis A/B vaccine.
- To evaluate this vaccine in children aged 1 to 15 years.
Main Methods:
- A three-dose schedule (0-, 1-, 6-month) of the combined vaccine was given to three pediatric groups (1-6 years and two groups of 6-15 years).
- Vaccine safety was monitored via diary cards for local and systemic reactions.
- Immunogenicity was assessed by seroconversion rates and geometric mean titers (GMTs) for antibodies against hepatitis A virus (HAV) and hepatitis B virus (HBV).
Main Results:
- The combined vaccine demonstrated good tolerability, with mild to moderate reactions that resolved spontaneously.
- Seroconversion rates against HAV and HBV were high (100% and 98.8% after two doses, respectively).
- Following three doses, all participants achieved seropositivity, with high GMTs for anti-HAV and anti-HBV antibodies across all age groups.
Conclusions:
- The combined pediatric hepatitis A/B vaccine is well-tolerated in children aged 1 to 15 years.
- The vaccine formulation is highly immunogenic, providing robust protection against both hepatitis A and B.
Background:
Pediatric monocomponent formulations of vaccines against hepatitis A and B have been proved to be safe and immunogenic in children.
Objectives:
To investigate the safety and immunogenicity of a combined hepatitis A/B vaccine in children 1 to 15 years of age.
Methods:
Three doses of a combined vaccine containing 360 enzyme-linked immunosorbent assay units of hepatitis A antigen and 10 microg of hepatitis B surface antigen were administered in a 0-, 1-, 6-month schedule to three groups of children: a group of 1- to 6-year-olds (n = 60); and two groups of 6- to 15-year-olds (both n = 60).
Results:
Reactogenicity, assessed using diary cards, was not affected by the age of the subjects or the vaccine lot and was similar to that described with the monocomponent vaccines. Local and systemic reactions were mostly mild or moderate and resolved spontaneously. One month after the second dose 100 and 98.8% of all three groups had seroconverted against hepatitis A virus and hepatitis B virus, respectively. After the third dose all subjects were seropositive for both components, with geometric mean titers for anti-hepatitis A virus of 6518 to 8907 mIU/ml and for anti-hepatitis B surface antibody of 7255 to 11732 mIU/ml in the three groups.
Conclusion:
The combined pediatric hepatitis A/B vaccine formulation was well-tolerated and highly immunogenic in children 1 to 15 years old.