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[The reactogenicity of Heberbiovac-HB vaccine at different doses]
M Díaz González1, O Navia Molina, J R Bravo González
1Instituto de Medicina Tropical Pedro Kourí.
Insights
The Heberbiovac-HB recombinant vaccine against hepatitis B virus showed low reactogenicity in children aged 6-9 years across different doses. This hepatitis B vaccine is recommended for effective protection.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Hepatitis B virus (HBV) infection poses a significant global health burden.
- Effective vaccination strategies are crucial for preventing HBV transmission.
- Recombinant vaccines offer a safe and viable alternative for hepatitis B prevention.
Purpose of the Study:
- To evaluate the reactogenicity of the Heberbiovac-HB recombinant vaccine against hepatitis B virus.
- To assess the safety profile of different Heberbiovac-HB vaccine dosages in pediatric populations.
- To determine the suitability of Heberbiovac-HB for routine hepatitis B immunization in children.
Main Methods:
- A study involving three groups of children aged 6-9 years was conducted.
- The Heberbiovac-HB vaccine, derived from yeast cells, was administered at doses of 10, 5, and 2.5 g.
- Vaccination followed a schedule of 0, 1, and 6 months, with symptomatology meticulously recorded.
Main Results:
- Overall observed symptomatology was low, affecting 12.2% of participants across all groups.
- Specific symptoms included febricula (7.0%), local pain (3.1%), and erythema (1.2%).
- No significant differences in reactogenicity were observed between different vaccine groups or sexes.
Conclusions:
- The Heberbiovac-HB recombinant vaccine demonstrated acceptable reactogenicity in children.
- The study supports the recommendation of Heberbiovac-HB for protection against hepatitis B virus.
- The vaccine's safety profile makes it a suitable option for pediatric hepatitis B immunization programs.
Abstract:
Reactogenicity was measured after applying the Heberbiovac-HB recombinant vaccine against hepatitis B virus to three groups of children aged 6-9 years. The vaccine was derived from yeast cells, administered at doses of 10, 5, and 2.5 g, with a schedule of 0, 1 and 6 months. The overall observed symptomatology was low (12.2%) in the three groups with 10.7%, 13.5%, and 12.3% for 10, 5, and 2.5 g, respectively. The predominant symptoms and signs were febricula (7.0%), local pain (3.1%), and erythema (1.2%). No significant differences were found when making a comparison between groups and sexes. An acceptable reactogenicity of the immunogen was confirmed, thus its use is recommended for the protection against hepatitis B virus.