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Immunogenicity and safety of low doses of recombinant yeast-derived hepatitis B vaccine
Insights
This study found that recombinant yeast-derived hepatitis B vaccine is safe and effective in children aged 1-12 years. Even a low dose of 0.6 microgram demonstrated adequate immunogenicity with a three-dose regimen.
Area of Science:
- Vaccinology
- Immunology
- Pediatrics
Background:
- Hepatitis B remains a significant global health concern.
- Effective vaccination strategies are crucial for preventing hepatitis B virus (HBV) infection.
Purpose of the Study:
- To evaluate the immunogenicity and safety of a recombinant yeast-derived hepatitis B vaccine.
- To assess different dosage levels (0.6, 1.25, 2.5, and 5.0 micrograms) in a pediatric population.
Main Methods:
- A randomized study involving 4 groups of children aged 1-12 years.
- Administration of three vaccine doses at 0, 1, and 5 months.
- Monitoring of antibody titers and adverse reactions over time.
Main Results:
- Satisfactory immunogenicity was observed across all tested vaccine doses.
- Antibody levels peaked at 9 months and remained stable for at least one year.
- 100% seroconversion in the 5.0 microgram group and >90% in others; no significant adverse events reported.
Conclusions:
- The recombinant yeast-derived hepatitis B vaccine demonstrates adequate immunogenicity and safety in children.
- Even the lowest dose (0.6 microgram) was effective when administered in a three-dose schedule.
- The vaccine is a viable option for pediatric hepatitis B prevention.
Abstract:
The immunogenicity and safety of recombinant yeast-derived hepatitis B vaccine given in doses of 0.6 microgram, 1.25 microgram, 2.5 micrograms and 5.0 micrograms were studied in 4 comparable groups of children aged 1-12 years. All children received three doses of vaccine at time 0, 1 month and 5 months. Immunogenicity appeared to be satisfactory in all 4 groups of children. In the early phase of the study, a dose-response relationship was observed but there was no significant difference in the geometric mean titre among all 4 groups for any period studied. Antibody levels peaked at 9 months, declining thereafter. The geometric mean titre one year after the first vaccine dose was not significantly lower than that at the peak (9 months) in any individual group studied. The second year geometric mean titre was similar in all 4 groups and lower than that of the first year. Sero-conversion with antibody titres greater than or equal to 10 mIU/ml was 100% in the 5.0 micrograms group and greater than 90% in the other 3 groups. There were no adverse reactions of any significance. The immunogenicity of recombinant yeast-derived hepatitis B vaccine was found to be adequate even at as low a dosage as 0.6 microgram when administered in a 3-dose regimen.