Hepatitis ANCT07889219
Study on the Long-Term Persistence of Immunity Induced by Inactivated Hepatitis A Vaccine
An observational study of Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This study is a single-center, open-label, controlled study. Its primary objective is to evaluate the 20-year persistence of immunity induced by the inactivated hepatitis A vaccine. At least 106 healthy participants aged 21-28 years will be enrolled. Read more about this study
- Who is it for?
- Ages 21 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Healive® and Havrix®
- Type of treatment
- Vaccines
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2026to 30 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants who received two doses of inactivated hepatitis A vaccine in the PRO-HA-4006 trial and were included in the study, aged 21 to 28 years at enrollment.
Who may be able to join
- Participants must meet all of the following criteria to be eligible for this study:
- Healthy participants aged 21-28 years who previously participated in PRO-HA-4006 and completed the full vaccination course;
- Participants who are able to understand and voluntarily sign the informed consent form;
- Provision of valid legal identification.
Who cannot join
- Individuals meeting any of the following criteria will be excluded from this study:
- History of hepatitis A virus infection;
- Receipt of any vaccine containing hepatitis A antigen since participation in the PRO-HA-4006 clinical study;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Coagulation abnormalities, such as coagulation factor deficiency or platelet abnormalities, or a history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture;
- In the investigator's judgment, any other factor that makes the participant unsuitable for participation in the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changzhou City Center for Disease Control and Prevention
Changzhou, Jiangsu
Wenguo Xu, +86 18912330198, 853574402@qq.com
About this study
Official title: A 20-Year Study of the Persistence of Immunity in Healthy Children Aged 1-8 Years Induced by Inactivated Hepatitis A Vaccine
This study is a single-center, open-label, controlled study. Its primary objective is to evaluate the 20-year persistence of immunity induced by the inactivated hepatitis A vaccine. At least 106 healthy participants aged 21-28 years will be enrolled. Participants will be selected from individuals who completed the full vaccination course in the PRO-HA-4006 clinical study (Three-Batch Consistency Study of Healive® in Healthy Children Aged 1-8 Years in Changzhou) . After voluntarily providing informed consent, each participant will undergo one venous blood collection of approximately 3.0 mL for hepatitis A antibody testing to assess the persistence of immunity induced by the hepatitis A vaccine.
- Conditions
- Hepatitis A
- Being tested
- Healive®, Havrix®
- Keywords
- Hepatitis A, Inactivated hepatitis A vaccine, Immune persistence
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healive®Biological
Healive® developed by Sinovac Biotech Co., Ltd, per dose containing 250 u antigen, two doses administered in the prior trial.
Havrix®Biological
The control vaccine (0.5 mL/dose) contained 720 ELISA units (El.U) antigen and 0.25 mg alum with 2-phenoxyethanol as preservative.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Participants received two doses of inactivated hepatitis A vaccine, Healive® in the PRO-HA-4006 trial. Receives: Biological: Healive® | |
| Control group | Participants received two doses inactivated hepatitis A vaccine, Havrix® in the PRO-HA-4006 trial. Receives: Biological: Havrix® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rate and geometric mean concentration (GMC) of hepatitis A antibodies at Year 20 after vaccination.
Evaluate the immune persistence of anti-HAV antibodies in serum 20 years after two doses of inactivated hepatitis A vaccine. Seropositivity is defined as anti-HAV antibody concentration ≥ 20 mIU/mL.
Measured: 20 years after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start2 Aug 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changzhou Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Wenguo Xu, Principal investigator, Changzhou City Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889219
- Sponsor's protocol ID
- PRO-HAV-4019
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided