Safety and immunogenicity of a new formulation of an inactivated hepatitis A vaccine
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Published on: May 11, 2020
R Dagan1, D Greenberg, P Goldenbertg-Gehtman
1Pediatric Infectious Disease Units, Soroka University Medical Centre and the Faculty of Health Sciences, Beer Sheva, Israel.
Insights
The inactivated hepatitis A vaccine, Avaxim, showed excellent safety and immunogenicity in children aged 18 months to 15 years. High seroconversion rates and acceptable reaction profiles were observed across all pediatric age groups.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Hepatitis A remains a significant public health concern globally.
- Effective vaccination strategies are crucial for preventing Hepatitis A Virus (HAV) infection, particularly in pediatric populations.
- Assessing the safety and immunogenicity of novel vaccine formulations is essential for public health.
Purpose of the Study:
- To evaluate the safety and immunogenicity of a new inactivated hepatitis A vaccine formulation, Avaxim.
- To assess vaccine response across different pediatric age groups.
- To determine antibody titers and reaction profiles following primary and booster vaccinations.
Main Methods:
- A monocentric, open trial involving 189 children aged 18 months to 15 years.
- Two doses of Avaxim administered six months apart.
- Antibody titers measured by radioimmunoassay; safety assessed via reported local and systemic reactions.
Main Results:
- High seroconversion rates (>94%) observed two weeks after the first dose, reaching 100% before the booster.
- Geometric Mean Titers (GMC) showed a 22.6-fold increase four weeks post-booster.
- Local reactions occurred in 18.2% (first dose) and 8.5% (booster); systemic reactions in 23.8% (first dose) and 11.4% (booster).
Conclusions:
- The inactivated hepatitis A vaccine, Avaxim, demonstrates a favorable safety and immunogenicity profile in children.
- The vaccine is well-tolerated and elicits robust immune responses across the studied pediatric age range.
- Avaxim represents a potentially valuable tool for pediatric hepatitis A prevention.
Abstract:
The safety and immunogenicity of a new formulation of the inactivated hepatitis A vaccine, Avaxim, was evaluated in 189 children, aged 18 months to 15 years in a monocentric, open trial. Two vaccinations were given six months apart. Enrollment was balanced within three age groups: 18 months to 3 years, 4-8 years and 9-15 years. Antibody titers were measured blindly by an independent laboratory using a modified radioimmunoassay. Two weeks after the first dose, seroconversion was achieved by 94.6, 94.3 and 96.4% of initially HAV-seronegative subjects (antibody titre <20 mIU/ml) in each age group (youngest to oldest, respectively), with corresponding geometric mean titre concentrations (GMC) of 72.2, 54.3 and 47.1 mIU/ml. Just before the booster dose, the seroconversion rate was 100% in all groups, and the corresponding GMC values were 163, 169 and 111 mIU/ml. All groups included, a 22.6-fold rise in GMC from prebooster levels was observed four weeks after the booster dose. An explanatory analysis suggested a tendency for higher antibody levels in younger children at all vaccination time points. Local reactions were noted in 18.2% of the vaccinees after the first dose and in 8.5% after the booster dose. The rates of systemic reactions were 23.8% after the first dose and 11.4% after the booster dose. Overall, this trial demonstrated the good safety and immunogenicity profile of this vaccine in children aged 18 months to 15 years of age.
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