Hepatitis A virus (HAV) remains a common infection in Thai children. Two HAV vaccines are available: inactivated vaccine (I-HAV, 2 doses) and live-attenuated vaccine (L-HAV, single dose), but neither is included in Thailand's national immunization program. Our previous randomized, active-controlled, open-label, non-inferiority trial trial found that some participants remained seronegative after one L-HAV dose (anti-HAV IgG \<1 S/CO) (preliminary data). This study aims to evaluate the immunogenicity and safety of an additional dose of I-HAV in healthy Thai children and adolescents who did not develop protective antibody levels after a single dose of L-HAV.
Hepatitis A virus (HAV) infection remains a common cause of viral hepatitis among children and adolescents in developing countries, including Thailand. Currently, two types of HAV vaccines are available in Thailand; (1) inactivated HAV vaccine (I-HAV) which is recommended as a 2-dose series administered 6 months apart, approved for use in children aged 1 year and older, and (2) live-attenuated HAV vaccine (L-HAV) which is recommended as a single dose, approved for children aged 18 months and older. However, as neither vaccine is included in Thailand's Expanded Programme on Immunization (EPI), the national vaccination coverage remains suboptimal. In 2024, the investigators conducted a randomized, active-controlled, open-label, non-inferiority trial to compare the immunogenicity and safety of the currently marketed I-HAV and L-HAV in healthy Thai children and adolescents aged 18 months to 18 years. Preliminary results showed that a proportion of participants remained seronegative following a single dose of L-HAV (anti-HAV IgG \<1 S/CO). Based on these findings, the investigators hypothesize that an additional dose of I-HAV may be necessary to achieve adequate seroprotection in this population. Therefore, the aim of this study is to evaluate the immunogenicity and safety of an additional dose of I-HAV in healthy Thai children and adolescents who did not develop protective antibody levels after a single dose of L-HAV.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
36
A formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain) Dose and administration: 0.5 mL intramuscular injection for participants age \<=18 years, and 1.0 mL intramuscular injection for participants age 19 years and above.
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand
RECRUITINGAnti-HAV immunoglobulin G (IgG) seropositivity rate
Anti-HAV IgG seropositivity rate (anti-HAV IgG \>= 1.0 S/CO) before and after an additional dose of I-HAV vaccine.
Time frame: at baseline (1 year after L-HAV vaccination) and 4 weeks after an additional I-HAV vaccination.
Incidence of adverse events following I-HAV vaccination
Adverse events, including solicited local and systemic reactions as well as serious adverse events, following an additional dose of I-HAV vaccine.
Time frame: immediate and until 4 weeks after an additional I-HAV vaccination.
Geometric mean concentration (GMC) of anti-HAV IgG level
Geometric mean concentration (GMC) of anti-HAV IgG level before and after an additional dose of I-HAV vaccine.
Time frame: at baseline (1 year after L-HAV vaccination) and 4 weeks after an additional I-HAV vaccination.
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