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| Name | Class |
|---|---|
| Faculty of Medicine, Chiang Mai University | UNKNOWN |
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Hepatitis A virus (HAV) remains a common infection among Thai children. Two types of HAV vaccines are available in Thailand: an inactivated vaccine (I-HAV, administered in two doses 6 months apart) and a live-attenuated vaccine (L-HAV, administered as a single dose). However, neither vaccine is currently included in Thailand's Expanded Programme on Immunization (EPI). In 2024, a randomized, active-controlled, open-label, non-inferiority trial was conducted to compare the immunogenicity and safety of the two-dose I-HAV with the single-dose L-HAV in healthy Thai children and adolescents aged 18 months to 18 years. This study aims to evaluate the long-term seropositive rate and immunogenicity of anti-HAV antibodies in this population following a single dose of L-HAV.
Hepatitis A virus (HAV) infection remains one of the most common causes of viral hepatitis among children and adolescents in developing countries, including Thailand. The virus is primarily transmitted through the ingestion of contaminated food or water, or through direct contact with an infected person. HAV typically causes acute hepatitis, ranging from mild illness to severe fulminant hepatitis (acute liver failure), but it does not lead to chronic liver disease. Vaccination is a highly effective strategy to prevent HAV infection and its serious complications.
Currently, two types of HAV vaccines are available in Thailand: (1) the inactivated HAV vaccine (I-HAV), which is administered in two doses six months apart and is approved for use in children aged 12 months and older; and (2) the live-attenuated HAV vaccine (L-HAV), administered as a single dose and approved for children aged 18 months and older. However, neither vaccine has been included in Thailand's Expanded Programme on Immunization (EPI), resulting in suboptimal vaccination coverage across the country.
In 2024, the investigators conducted a randomized, active-controlled, open-label, non-inferiority trial to compare the immunogenicity and safety of the two-dose I-HAV regimen with the single-dose L-HAV in healthy Thai children and adolescents aged 18 months to 18 years. The present study aims to assess the long-term seropositive rate and immunogenicity of anti-HAV antibodies among these participants following a single dose of L-HAV.
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| Measure | Description | Time Frame |
|---|---|---|
| Anti-HAV seropositivity rate | Anti-HAV seropositivity rate following a single L-HAV vaccine | 1 year after L-HAV vaccination |
| Anti-HAV antibody level | Geometric mean concentration (GMC) of anti-HAV antibodies following a single L-HAV vaccine | 1 year after L-HAV vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Thai children and adolescents age 18 months to 20 years who received a single dose of L-HAV vaccine in the previous RCT study.
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| Name | Affiliation | Role |
|---|---|---|
| Tavitiya Sudjaritruk, MD, PhD | Department of Pediatrics, Faculty of Medicine, Chiang Mai University | Study Chair |
| Natchaya Kunanitthaworn, MD | Department of Pediatrics, Faculty of Medicine, Chiang Mai University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Faculty of Medicine, Chiang Mai University | Chiang Mai | 50200 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27345175 | Background | Ma F, Yang J, Kang G, Sun Q, Lu P, Zhao Y, Wang Z, Luo J, Wang Z. Comparison of the safety and immunogenicity of live attenuated and inactivated hepatitis A vaccine in healthy Chinese children aged 18 months to 16 years: results from a randomized, parallel controlled, phase IV study. Clin Microbiol Infect. 2016 Sep;22(9):811.e9-811.e15. doi: 10.1016/j.cmi.2016.06.004. Epub 2016 Jun 23. | |
| 23571173 |
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There is not a plan to make individual participant data (IPD) available to other researchers for this study.
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| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| D006505 | Hepatitis |
| D000079263 | Vaccine-Preventable Diseases |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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Serum samples
| Background |
| Liu XE, Wushouer F, Gou A, Kuerban M, Li X, Sun Y, Zhang J, Liu Y, Li J, Zhuang H. Comparison of immunogenicity between inactivated and live attenuated hepatitis A vaccines: a single-blind, randomized, parallel-group clinical trial among children in Xinjiang Uighur Autonomous Region, China. Hum Vaccin Immunother. 2013 Jul;9(7):1460-5. doi: 10.4161/hv.24366. Epub 2013 Apr 9. |
| 37833325 | Result | Kunanitthaworn N, Mueangmo O, Saheng J, Wongjak W, Lertsiriladakul T, Chaito T, Nantarat P, Sudjaritruk T. Seroprevalence of hepatitis A virus antibodies among children and adolescents living in Northern Thailand: an implication for hepatitis A immunization. Sci Rep. 2023 Oct 13;13(1):17432. doi: 10.1038/s41598-023-44643-0. |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |