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A modified immunisation schedule for the hepatitis B vaccine Recombivax HB suitable for mass vaccination in childhood
M Piazza1, N Abrescia, L Picciotto
1Clinica delle Malattie Infettive, Università di Napoli.
Insights
This study shows that Recombivax HB, a hepatitis B vaccine, is highly effective when given alongside routine childhood immunizations. This allows for integrated vaccination schedules in infants, supporting mass vaccination campaigns.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Hepatitis B vaccination protocols are crucial for preventing infection.
- Previous studies confirmed the immunogenicity of Hevac B Pasteur, H-B-VAX, and Engerix B vaccines when co-administered with routine childhood immunizations in Italy.
- A DNA-recombinant hepatitis B vaccine, Recombivax HB, was recently introduced in Italy.
Purpose of the Study:
- To evaluate the immunogenicity of the Recombivax HB vaccine when administered on a schedule compatible with mandatory Italian childhood vaccinations.
- To determine if Recombivax HB can be integrated into existing infant immunization programs.
Main Methods:
- A cohort of infants received two doses of Recombivax HB at three and five months of age.
- Immunogenicity was assessed by measuring seroconversion rates and mean anti-HBs titres.
- The vaccination schedule was designed to align with mandatory diphtheria, tetanus, and polio vaccinations.
Main Results:
- Two doses of Recombivax HB resulted in a 100% seroconversion rate.
- The mean anti-HBs titre achieved was 440 mUI/ml.
- These results suggest high immunogenicity, supporting a complete three-dose schedule.
Conclusions:
- Recombivax HB demonstrates excellent immunogenicity in infants when administered concurrently with routine childhood vaccinations.
- The vaccine is suitable for inclusion in mass vaccination campaigns for infants in Italy.
- This integrated approach facilitates efficient hepatitis B prevention, as exemplified by the first European mass vaccination campaign initiated in an hyperendemic area.
Abstract:
Following the demonstration of a fully satisfactory immunogenic activity of a hepatitis B vaccination protocol consisting of three doses of Hevac B Pasteur vaccine given at 3,5 and 11 months of age, it was possible to administer this vaccine at the same times as the vaccinations for diphtheria, tetanus and polio which are mandatory in Italy at those ages. We have also shown that both another plasma-derived vaccine, H-B-VAX (MSD), as well as the DNA-recombinant Engerix B (SK&F) are highly immunogenic when given at the same times as the mandatory childhood vaccinations. In this paper we demonstrate that the same schedule can be used for another hepatitis B vaccine prepared by a DNA-recombinant technique, Recombivax HB (MSD) recently introduced in Italy. In fact two doses of this vaccine, the first given at three months of age and the second two months later, resulted in a 100% seroconversion rate and a mean anti-HBs titre of 440 mUI/ml. Although the date are incomplete since the third dose will be given at 11 months of age, we conclude that this hepatitis B vaccine can also be used in the mass vaccination campaigns of infants in Italy, the first of which was initiated in January 1987 in an hyperendemic area near Naples (HBsAg prevalence about 14%). We underline that this mass vaccination campaign is the first in Europe.