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Published on: December 1, 2017
Reactogenicity and immunogenicity profile of a two-dose combined hepatitis A and B vaccine in 1-11-year-old children
D Roberton1, H Marshall, T M Nolan
1Department of Paediatrics, Children, Youth and Women's Health Service, North Adelaide SA 5006, Australia. don.roberton@adelaide.edu.au
Insights
A new two-dose hepatitis A and B vaccine shows comparable safety and immunogenicity to the existing three-dose schedule in children. This simplified vaccination offers excellent protection against both viruses.
Area of Science:
- Pediatric Vaccinology
- Infectious Disease Prevention
- Immunology
Background:
- The established hepatitis A and B vaccine requires a three-dose schedule (0, 1, 6 months).
- Evaluating alternative, potentially more convenient vaccination schedules is crucial for public health.
- Combined vaccines offer advantages in simplifying immunization protocols.
Purpose of the Study:
- To compare the safety, reactogenicity, and immunogenicity of a two-dose combined hepatitis A and B vaccine with a three-dose regimen.
- To assess vaccine performance across different pediatric age groups (1-5 and 6-11 years).
Main Methods:
- A study involving 511 children aged 1-11 years who were unvaccinated against hepatitis A or B.
- Administration of either a two-dose (0, 6 months) or a three-dose (0, 1, 6 months) combined hepatitis A and B vaccine.
- Evaluation of reactogenicity, safety, and immunogenicity (seroprotection for HepB, seroconversion for HepA) one month post-vaccination.
Main Results:
- Both vaccine schedules were well-tolerated, safe, and immunogenic in children.
- The two-dose schedule demonstrated a reactogenicity profile comparable to the three-dose schedule.
- Both regimens achieved high efficacy: ≥98% seroprotection against hepatitis B and 100% seroconversion against hepatitis A.
Conclusions:
- A two-dose combined hepatitis A and B vaccine is a safe and effective alternative to the established three-dose schedule.
- The simplified two-dose regimen provides robust immunogenicity and protection in children.
- This offers a more convenient vaccination option for hepatitis A and B prevention.
Abstract:
This study was conducted to compare the reactogenicity, immunogenicity and safety of a combined two-dose (0, 6 months) hepatitis A and B vaccine (720ELU HAV, 20 mcg HBsAg) with the established three-dose (0, 1 and 6 months) hepatitis A and B vaccine (360ELU HAV, 10 mcg HBsAg). A total of 511 children aged 1-11 years who had not previously received a hepatitis A or B vaccine were enrolled in the study. Both vaccines were well tolerated, and were shown to be safe and immunogenic. The analysis, stratified according to two age groups (1-5 year and 6-11-year-old children) demonstrated that the reactogenicity profile of the two-dose schedule was at least as good as that of the established schedule. Both vaccines and schedules provided at least 98% seroprotection against hepatitis B and 100% seroconversion against hepatitis A, 1 month after the end of the vaccination course (Month 7).
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