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

March 6, 2024 updated by: Tavitiya Sudjaritruk, Chiang Mai University

Comparison of Immunogenicity and Safety of Inactivated and Live-attenuated Hepatitis A Virus Vaccine Among Thai Healthy Children and Adolescents: A Randomized, Active-controlled, Open-label, Non-inferiority Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatitis A virus (HAV) infection is one of the common cause of viral hepatitis in children and adolescents in developing countries, including Thailand. This virus is easily transmitted through ingestion of contaminated food and water or through direct contact with an infectious person. Generally, HAV causes acute hepatitis, ranging mild illness to severe fulminant hepatitis (acute liver failure), but does not cause chronic liver disease. HAV vaccine is an effective strategy to prevent natural HAV infection as well as serious consequences of the illness.

Currently, there are 2 types of HAV vaccine available in Thailand, including (1) inactivated vaccine (I-HAV) which is recommended for 2 doses, 6 months apart and is approved for children age 1 year and above; and (2) live-attenuated vaccine (L-HAV) which is recommended for 1 dose and is approved for children age 18 months and above. However, these vaccines have not included in the Thailand Expanded Programme on Immunization (EPI) yet. Thus, vaccination coverage rate is suboptimal in the country. Moreover, the information regarding immunogenicity and safety of both vaccines is limited.

This is a randomized, active-controlled, open-label, non-inferiority trial which aims to compare the immunogenicity and safety of a marketed inactivated (I-HAV) and a live-attenuated HAV vaccine (L-HAV) among Thai healthy children and adolescents age 18 months to 18 years. This study will provide important information about the immunogenicity and safety profiles of both vaccines in Thai healthy youth as well as demonstrate the associated factors of HAV vaccine-elicited immunity in this population.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-HAV
Live-attenuated hepatitis A vaccine.
Biological: Mevac-A vaccine

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.
Active Comparator: I-HAV
Inactivated hepatitis A vaccine.
Biological: Havrix 720 Junior

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HAV immunoglobulin G (IgG) seroconversion rate
Time Frame: L-HAV group: 4 weeks after the first vaccination. I-HAV group: 4 weeks after the second vaccination
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric mean concentration (GMC) of anti-HAV IgG level
Time Frame: Baseline (before the first vaccination), 4 weeks after the first vaccination, and 4 weeks after the second vaccination (for I-HAV group only).
Geometric mean concentration (GMC) of anti-HAV IgG level before the first vaccination, 4 weeks after the first vaccination, and 4 weeks after the second vaccination (for I-HAV group only).
Baseline (before the first vaccination), 4 weeks after the first vaccination, and 4 weeks after the second vaccination (for I-HAV group only).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Collaborators

Faculty of Medicine, Chiang Mai University

Investigators

  • Study Chair: Tavitiya Sudjaritruk, MD, PhD, Department of Pediatrics, Faculty of Medicine, Chiang Mai University
  • Principal Investigator: Natchaya Kunanitthaworn, MD, Department of Pediatrics, Faculty of Medicine, Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED-2566-0634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data (IPD) available for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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