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Safety and immunogenicity of hepatitis A vaccine in healthy children
Y C Horng1, M H Chang, C Y Lee
1Department of Pediatrics, College of Medicine, National Taiwan University, Taipei, Republic of China.
Insights
This study shows an inactivated hepatitis A (HA) vaccine is highly immunogenic and safe for children. It achieved high seroconversion rates, suggesting it can effectively prevent HA virus infection.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Hepatitis A Virus (HAV) Research
Background:
- Hepatitis A virus (HAV) infection poses a significant risk to children, particularly in endemic areas.
- Current prevention methods like immunoglobulin may be less effective or convenient than vaccination.
- Assessing the safety and efficacy of inactivated HAV vaccines in pediatric populations is crucial.
Purpose of the Study:
- To evaluate the immunogenicity and reactogenicity of an inactivated hepatitis A vaccine in healthy children.
- To determine the seroconversion rates and antibody titers following a three-dose vaccination schedule.
- To compare the vaccine's safety profile with existing prevention strategies.
Main Methods:
- A cohort of 103 healthy children (3 months to 6 years 8 months) lacking anti-HAV antibodies were enrolled.
- Participants received three doses of 360 ELISA units of inactivated HA vaccine on a 0-, 1-, and 6-month schedule.
- Blood samples were collected pre-vaccination and at 1, 6, and 7 months post-first dose to measure aminotransferase and anti-HAV antibody levels via radioimmunoassay and enzyme immunoassay.
Main Results:
- High seroconversion rates were observed: 95.1% at 1 month and 100% at 6 and 7 months post-vaccination, as measured by enzyme immunoassay.
- The vaccine demonstrated a favorable safety profile, with 9% of injections causing mild local reactions (soreness, swelling) and 12% causing minor general symptoms.
- No significant adverse events related to aminotransferase levels were reported, indicating good tolerability.
Conclusions:
- The inactivated hepatitis A vaccine is highly immunogenic and safe for use in children.
- The vaccine shows potential to replace immunoglobulin for preventing hepatitis A virus infection in pediatric populations.
- Administration of this HA vaccine is recommended for children, especially in areas where hepatitis A is endemic.
Abstract:
The immunogenicity and reactogenicity of an inactivated hepatitis A (HA) vaccine in children were investigated. One hundred three healthy children who lacked antibody to HA virus (anti-HA virus), aged between 3 months and 6 years 8 months, were enrolled in this study. They received three doses of 360 enzyme-linked immunosorbent assay units of HA vaccine in a 0-, 1- and 6-month schedule. Blood tests for aminotransferase and anti-HA virus were performed 7 days before and 1, 6 and 7 months after the first dose. Anti-HA virus was tested by radioimmunoassay and also by enzyme immunoassay for titer determination. The seroconversion rates measured by enzyme immunoassay were 95.1% (98 of 103) at Month 1 and 100% at Months 6 and 7. Nine percent (28 of 309) of the injections were followed by local symptoms, usually mild soreness and swelling at the site of injection, and 12% (37 of 309) by minor general symptoms. We conclude that HA vaccine is highly immunogenic and safe in children. It may replace immunoglobulin as an effective method to prevent HA virus infection in children. We also suggest that the HA vaccine be administered to children in endemic areas.