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A simplified schedule to integrate the hepatitis B vaccine into an expanded program of immunization in endemic
1Department of Pediatrics, National Taiwan University Hospital, Taipel, Republic of China.
Insights
A simplified hepatitis B vaccination schedule integrating the vaccine into the Expanded Programme of Immunization proved safe, immunogenic, and effective. This approach enhances vaccine compliance for infants, especially those at high risk of hepatitis B.
Area of Science:
- Pediatrics
- Immunology
- Public Health
Background:
- The hepatitis B vaccine is crucial for preventing perinatal transmission and chronic infection.
- Integrating hepatitis B vaccination into routine infant immunization schedules can improve coverage.
- A simplified schedule may enhance compliance and reduce the burden on healthcare systems.
Purpose of the Study:
- To evaluate the safety, immunogenicity, and efficacy of a simplified hepatitis B vaccination schedule.
- To assess the feasibility of combining hepatitis B vaccine with diphtheria-tetanus-pertussis (DTP) vaccines.
- To determine the protective efficacy against hepatitis B carrier state in high-risk infants.
Main Methods:
- A simplified schedule involved simultaneous administration of hepatitis B and DTP vaccines at 6 weeks, 3.5 months, and 5.5 months.
- Two infant groups were studied: Group A (low risk) received whole-cell DTP, and Group B (high risk) received acellular DTP.
- Infants were monitored for hepatitis B surface antigen (HBsAg) seropositivity and antibody levels by 9 months of age.
Main Results:
- None of Group A infants and 7% of Group B infants were HBsAg seropositive by 9 months.
- The protective efficacy against the hepatitis B carrier state was 92% in high-risk infants.
- Antibody levels to hepatitis B surface antigen were protective (≥10 mIU/ml) in 96% of Group A and 91% of Group B infants.
Conclusions:
- The simplified hepatitis B vaccination schedule is safe, immunogenic, and effective.
- This integrated schedule improves vaccine compliance and can be applied to combination vaccines.
- The findings support the use of simplified schedules in routine immunization programs to combat hepatitis B.
Objective:
To investigate the safety, immunogenicity, and efficacy of a simplified hepatitis B vaccination schedule.
Methods:
The second dose of hepatitis B vaccine and the first dose of diphtheria-tetanus-pertussis (DTP) vaccine were given simultaneously at age 6 weeks. The second dose of DTP vaccine was given at age 3.5 months. The third dose of DTP vaccine and the third dose of hepatitis B vaccine were given at age 5.5 months. One hundred three infants (group A) born to mothers without hepatitis B surface antigen (HBsAg) received DTP with whole-cell pertussis vaccine. Fifty-five infants (group B) born to mothers with HBsAg and hepatitis B e antigen received DTP with acellular pertussis vaccine.
Results:
By age 9 months, none of group A and 4 (7%) group B infants were sero-positive for HBsAg. The protective efficacy against the hepatitis B carrier state in these infants at high risk was 92%. Antibody to hepatitis B surface antigen was 10 mlU/ml or greater in 99 (96%) of group A infants and in 50 (91%) of group B infants. Both the acellular and whole-cell DTP vaccines were immunogenic, and the incidences of adverse reactions were within an expected and acceptable range.
Conclusions:
The simplified vaccination schedule to integrate the hepatitis B vaccine into the Expanded Programme of Immunization was safe, Immunogenic, and effective. This schedule may improve vaccine compliance and be applied to DTP and hepatitis B combination vaccines now under investigation.