Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV

NCT06978621 | Recruiting Phase 3

• 1 other identifier: PED-2568-0180
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis A; Hepatitis A Virus; Vaccine-Preventable Diseases

Keywords

Inacitivated hepatitis A vaccine; Safety; Immunogenicity; Clinical trial

Outcome Measures

Primary Outcomes (2)

• Anti-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.

  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.

  immediate and until 4 weeks after an additional I-HAV vaccination.

Secondary Outcomes (1)

• Geometric mean concentration (GMC) of anti-HAV IgG level

  at baseline (1 year after L-HAV vaccination) and 4 weeks after an additional I-HAV vaccination.

Study Arms (1)

Inactivated HAV vaccine (I-HAV)

EXPERIMENTAL

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).

Biological: Inactivated hepatitis A vaccine (I-HAV)

Interventions

Inactivated hepatitis A vaccine (I-HAV) BIOLOGICAL

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.

Inactivated HAV vaccine (I-HAV)

Eligibility Criteria

• Age: 18 Months - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Thai children and adolescents who previously participated in the previous RCT study
• 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

You may not qualify if:

• History of acute illness within 4 weeks prior to study enrollment
• 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

Sponsors & Collaborators

• Chiang Mai University: lead
• Faculty of Medicine, Chiang Mai University: collaborator

Study Sites (1)

Department of Pediatrics, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (3)

• 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.

  PMID: 37833325 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.

  PMID: 27345175 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.

  PMID: 23571173 BACKGROUND

MeSH Terms

Conditions

Hepatitis A; Hepatitis; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Study Officials

• 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

Central Study Contacts

Tavitiya Sudjaritruk, MD, PhD

CONTACT

+66-53-936471; tavitiya.s@cmu.ac.th

Natchaya Kunanitthaworn, MD

CONTACT

+66-53-936461; natchaya.k@cmu.ac.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: May 25, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)