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Safety and immunogenicity of live attenuated hepatitis A virus vaccine (H2 strain) in humans
Insights
This study evaluated a live attenuated hepatitis A virus (HAV) vaccine in children. The vaccine demonstrated good safety and immunogenicity across different dosages, indicating its potential for widespread use.
Area of Science:
- Virology
- Immunology
- Vaccinology
Background:
- Hepatitis A virus (HAV) infection poses a significant public health concern.
- Development of safe and effective vaccines is crucial for disease prevention.
Purpose of the Study:
- To assess the safety and immunogenicity of a live attenuated HAV vaccine (H2 strain) in children.
- To determine optimal dosage for the live attenuated HAV vaccine.
Main Methods:
- A subcutaneous injection study involving 3,031 children aged 6-9 years.
- Administration of three different doses of the live attenuated HAV vaccine: 10(6.0), 10(5.5), and 10(5.0) TCID50.
- Monitoring of seroconversion rates and antibody geometric mean titers (GMT) over 12 months, with control and oral administration groups for comparison.
Main Results:
- High seroconversion rates (53.23%-97.52%) and significant antibody GMT were observed across all tested vaccine doses.
- The vaccine was found to be safe, with only minor adverse events noted.
- Control groups remained anti-HAV negative, and oral administration showed limited antibody response.
Conclusions:
- The live attenuated HAV vaccine (H2 strain) exhibits favorable immunogenicity and a good safety profile in children.
- The study supports the potential of this live attenuated HAV vaccine for hepatitis A prevention.
Abstract:
A study was made in Neijiang City, Sichuan Province to observe the safety and immunogenicity of a live attenuated hepatitis A virus (HAV) vaccine (H2 strain). 3,031 children, aged 6 to 9 years, were injected subcutaneously with 10(6.0) TCID50, 10(5.5) TCID50, and 10(5.0) TCID50 of HAV vaccine; the seroconversion rate and antibody GMT were 97.52%-90.68%, GMT = 1:5.19 +/- 1.90-1:3.36 +/- 1.94; 84.75%-76.27%, GMT = 1:4.29 +/- 1.96-1:2.0 +/- 2.67; 53.23%-51.61%, GMT = 1:2.57 +/- 1.89-1:1.68 +/- 1.41 respectively after 4 weeks to 12 months of inoculation. Forty-eight children in the control group were anti-HAV negative at 4, 8, and 12 weeks; 21 children in the oral group were not antibody positive 4 and 8 weeks after oral administration of the vaccine. The stool specimens of 3 of the 14 vaccinated children were HAA positive. The results suggest that the live attenuated HAV vaccine (H2 strain) is of good immunogenicity and safety.