How long immunity lasts after inactivated hepatitis A vaccine
Official title: A 20-Year Study of the Persistence of Immunity in Healthy Children Aged 1-8 Years Induced by Inactivated Hepatitis A Vaccine
Run by Sinovac Biotech Co., Ltd · NCT07889219 · Data updated 2026-11-12
This study tests if immunity from the inactivated hepatitis A vaccine lasts up to 20 years in adults who completed the vaccination course in a prior trial.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years to 28 Years |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Sinovac Biotech Co., Ltd Industry-sponsored |
| Locations | 1 site (Changzhou, Jiangsu) |
| Status | Recruiting |
| Started | August 2, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07889219 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults 21–28 years old who previously completed the PRO-HA-4006 vaccination course.
✕Probably not a fit
Individuals without prior PRO-HA-4006 participation or those with contraindications to blood draws may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, open-label observational study led by Sinovac in Changzhou. It will enroll at least 106 healthy adults aged 21–28 who previously completed the PRO-HA-4006 vaccination series. Participants will provide informed consent and have a one-time blood draw (about 3 mL) to measure hepatitis A antibody persistence. Interventions involve the licensed vaccines Healive and Havrix as background exposures. The study aims to characterize how long the immune response from vaccination persists over two decades.
Why it matters
Potential benefit: If successful, the study could clarify long-term protection after vaccination and help guide future immunization recommendations.
How similar studies have gone: Previous vaccine studies have shown ongoing but waning antibody persistence over time; this study builds on those observations with a longer time horizon.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for this study: 1. Healthy participants aged 21-28 years who previously participated in PRO-HA-4006 and completed the full vaccination course; 2. Participants who are able to understand and voluntarily sign the informed consent form; 3. Provision of valid legal identification. Exclusion Criteria: Individuals meeting any of the following criteria will be excluded from this study: 1. History of hepatitis A virus infection; 2. Receipt of any vaccine containing hepatitis A antigen since participation in the PRO-HA-4006 clinical study; 3. Autoimmune disease or immunodeficiency/immunosuppression; 4. Coagulation abnormalities, such as coagulation factor deficiency or platelet abnormalities, or a history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture; 5. In the investigator's judgment, any other factor that makes the participant unsuitable for participation in the clinical study.
Where it's running
-
Changzhou City Center for Disease Control and Prevention
Changzhou, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Wenguo Xu — Changzhou City Center for Disease Control and Prevention
- Study coordinator: Wenguo Xu
- Email: 853574402@qq.com
- Phone: +86 18912330198
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.