Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents
Launched by CHIANG MAI UNIVERSITY · Jun 16, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well a single dose of the live-attenuated hepatitis A vaccine (L-HAV) protects healthy Thai children and teenagers against hepatitis A over a long period. Hepatitis A is a common liver infection spread through contaminated food or water, and vaccines can help prevent it. In Thailand, two types of hepatitis A vaccines are available: one given in two doses (inactivated vaccine) and another given as a single dose (live-attenuated vaccine). This study focuses on children and adolescents who already received one dose of the live-attenuated vaccine about a year ago, to see how well their bodies are still protected.
To join the study, participants must be Thai children or teenagers aged between roughly 1.5 and 18 years who were part of a previous related vaccine study and got the live-attenuated vaccine. They and their caregivers need to agree to take part by signing a consent form. People who have recently been sick, have had hepatitis A before, received extra hepatitis A vaccines since the last study, or have certain symptoms like fever or jaundice won’t be eligible. Participants can expect to have their blood tested to check their immunity against hepatitis A and will be monitored to make sure the vaccine remains safe and effective over time. This study will help doctors understand how long the single-dose vaccine can protect children and could guide future vaccine programs in Thailand.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Chiang Mai University
Chiang Mai University, a prestigious institution in Thailand, is dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. With a strong emphasis on ethical standards and scientific rigor, the university collaborates with local and international partners to explore novel therapies and interventions across various medical fields. Its commitment to education and research excellence fosters an environment where groundbreaking studies can thrive, ultimately contributing to the enhancement of patient care and the development of new medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chiang Mai, , Thailand
Patients applied
Trial Officials
Tavitiya Sudjaritruk, MD, PhD
Study Chair
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Natchaya Kunanitthaworn, MD
Principal Investigator
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported