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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 20-Year Study of the Persistence of Immunity in Healthy Children Aged 1-8 Years Induced by Inactivated Hepatitis A Vaccine
- ClinicalTrials.gov ID
- NCT07889219
- Acronym / sponsor ID
- PRO-HAV-4019
- Conditions
- Hepatitis A
- Keywords
- Hepatitis A, Inactivated hepatitis A vaccine, Immune persistence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Changzhou Center for Disease Control and Prevention
- Study start
- 2 Aug 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | – | Biological: Healive®Participants received two doses of inactivated hepatitis A vaccine, Healive® in the PRO-HA-4006 trial. |
| Control group | – | Biological: Havrix®Participants received two doses inactivated hepatitis A vaccine, Havrix® in the PRO-HA-4006 trial. |
Who may qualify
- Ages
- 21 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healive®Healive® developed by Sinovac Biotech Co., Ltd, per dose containing 250 u antigen, two doses administered in the prior trial. | Biological | Trial group |
| Havrix®The control vaccine (0.5 mL/dose) contained 720 ELISA units (El.U) antigen and 0.25 mg alum with 2-phenoxyethanol as preservative. | Biological | Control group |
Primary outcome
Seropositivity rate and geometric mean concentration (GMC) of hepatitis A antibodies at Year 20 after vaccination.
Time frame: 20 years 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenguo Xu principal investigator
Changzhou City Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenguo Xu (+86 18912330198, 853574402@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositivity rate and geometric mean concentration (GMC) of hepatitis A antibodies at Year 20 after vaccination. (time frame: 20 years after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.