Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents

NCT07032610 | Not Yet Recruiting

• 1 other identifier: PED-2568-0420
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis A; Hepatitis A Virus; Vaccine-Preventable Diseases

Keywords

Live-attenuated hepatitis A vaccine; Immunogenicity; Seropositive rate

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

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

Study Population

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.

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 (+/- 3 months)
• 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
• 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

Location

Related Publications (3)

• 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

• 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 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

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: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start: June 22, 2025
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)