Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents

NCT06298708 | Completed Phase 3

• 1 other identifier: PED-2566-0634
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years.

Conditions

HAV; Hepatitis A; Hep A; Vaccine-Preventable Diseases

Keywords

HAV vaccine; immunogenicity; safety; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Anti-HAV immunoglobulin G (IgG) seroconversion rate

  Anti-HAV IgG seroconversion rate (anti-HAV IgG \>= 1.0 S/CO) after the first vaccination for L-HAV group and after the second vaccination for I-HAV group, among participants with anti-HAV IgG \<1.0 S/CO at baseline.

  L-HAV group: 4 weeks after the first vaccination. I-HAV group: 4 weeks after the second vaccination

Secondary Outcomes (1)

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

  Baseline (before the first vaccination), 4 weeks after the first vaccination, and 4 weeks after the second vaccination (for I-HAV group only).

Study Arms (2)

L-HAV

EXPERIMENTAL

Live-attenuated hepatitis A vaccine.

Biological: Mevac-A vaccine

I-HAV

ACTIVE COMPARATOR

Inactivated hepatitis A vaccine.

Biological: Havrix 720 Junior

Interventions

Mevac-A vaccine BIOLOGICAL

Mevac-A: A freeze-dried live-attenuated hepatitis A vaccine. Dose and administration: a freeze-dried live-attenuated vaccine, subcutaneous injection of 0.5 ml will be administered for 1 time.

L-HAV

Havrix 720 Junior BIOLOGICAL

Havrix 720 Junior: An inactivated hepatitis A vaccine, 720 ELISA units per 0.5 ml of formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain). Dose and administration: a pre-filled syringe, intramuscular injection of 0.5 ml will be administered for 2 times with 6-month interval.

I-HAV

Eligibility Criteria

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

You may qualify if:

• Age between 18 months and 18 years
• Has healthy status
• Has no history of hepatitis A infection or previous hepatitis A disease
• Has never received hepatitis A vaccine (from vaccine booklet or parental history)
• Participants and/or caregivers gives written inform consent/assent form

You may not qualify if:

• Has acute illness within 4 weeks before enrollment
• Has fever with jaundice within 4 weeks before enrollment
• Has underlying disease of thrombocytopenia, coagulopathy, hemophilia A or B, neurologic disease, immunocompromised condition, chronic liver disease, chronic hepatitis B or C infection
• Has received immunosuppressive agents or immunomodulatory agents, corticosteroid \>2 mg/kg/day or 20 mg/day within 6 months before enrollment
• Has received blood or blood component, or intravenous immunoglobulin within 6 months before enrollment
• Has received any lived-attenuated vaccine within 30 days before enrollment
• Has history of severe allergy to vaccine or vaccine component, including aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, gentamicin sulfate, or has history of anaphylaxis or severe allergic reactions following vaccination
• 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

Location

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; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; 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

Study Design

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

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 27, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)