Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
NCT ID: NCT06978621
Last Updated: 2025-06-17
Study Results
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Basic Information
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RECRUITING
PHASE3
36 participants
INTERVENTIONAL
2025-05-25
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Inactivated HAV vaccine (I-HAV)
An additional dose of inactivated hepatitis A vaccination for participants who have seronegative (anti-HAV IgG \<1 S/CO) at baseline (1 year after a single dose of live-attenuated hepatitis A vaccine).
Inactivated hepatitis A vaccine (I-HAV)
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.
Interventions
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Inactivated hepatitis A vaccine (I-HAV)
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.
Eligibility Criteria
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Inclusion Criteria
* Previously randomized to receive one dose of L-HAV vaccine within the past 1 year (+/- 2 months)
* Have not demonstrate a seropositivity against HAV (anti-HAV IgG \<1 S/CO) at 1 month after L-HAV vaccination
* Participants and/or caregivers gives written inform consent/assent form
Exclusion Criteria
* Has a history of illness or a diagnosis consistent with hepatitis A after receiving the live attenuated hepatitis A vaccine as part of participation in a previous research study
* Has a history of receiving any additional hepatitis A vaccine after participating in the previous research study
* Presence of fever (body temperature ≥38.0°C), jaundice, or yellowing of the eyes within 4 weeks prior to study enrollment
* Has underlying conditions including thrombocytopenia, coagulopathy, hemophilia A or B, neurological disorders, immunodeficiency disorders, chronic liver disease, or chronic hepatitis B or C infection
* Has received immunosuppressive agents, immunomodulatory agents, or high-dose corticosteroids (greater than 2 mg/kg/day or more than 20 mg/day) for more than 14 consecutive days within 6 months prior to study enrollment
* Has received blood products or blood components, including immunoglobulins, within 6 months prior to study enrollment
* Has received other live vaccines within 30 days prior to study enrollment
* Has history of allergy to vaccines or any vaccine components, such as aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, or gentamicin sulfate, or has history of severe allergic reactions (e.g., anaphylaxis) to any vaccines
* Women planning for pregnancy, pregnant women or lactating women
* Women in childbearing age who cannot use contraceptive methods during study participation
* Is concurrently involved in other clinical trials in which receiving an investigational vaccine or study drug as part of study participation
* Have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study
18 Months
20 Years
ALL
Yes
Sponsors
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Faculty of Medicine, Chiang Mai University
UNKNOWN
Chiang Mai University
OTHER
Responsible Party
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Tavitiya Sudjaritruk
Associate Professor
Principal Investigators
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Tavitiya Sudjaritruk, MD, PhD
Role: STUDY_CHAIR
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Natchaya Kunanitthaworn, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Locations
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Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Chiang Mai, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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PED-2568-0180
Identifier Type: -
Identifier Source: org_study_id
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