Hepatitis ANCT07855705
A Study to Evaluate the 17-Year Immune Persistence of a Single Dose of Inactivated Hepatitis A Vaccine
An observational study of Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this follow-up study is to evaluate the seventeen-year immune persistence of a single dose of inactivated or attenuated alive hepatitis A vaccine in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Inactivated HAV vaccine and Attenuated live HAV vaccine
- Type of treatment
- Vaccines
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2026to 9 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants who received a single dose of inactivated or live attenuated hepatitis A vaccine in the PRO-HA-4013 trial and were included in the study, aged 18 to 22 years at enrollment.
Who may be able to join
- Participants who were included in the Full Analysis Set (FAS) of the PRO-HA-4013 trial;
- Able to understand and voluntarily sign the informed consent form;
- Able to provide legal identification.
Who cannot join
- History of hepatitis A virus infection;
- Receipt of any vaccine containing hepatitis A antigen since participation in the PRO-HA-4013 trial;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Coagulation abnormality (e.g., coagulation factor deficiency, platelet abnormality), or obvious bleeding, hematoma or ecchymosis after prior intramuscular injection or venipuncture;
- Any other condition judged by the investigator to be unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase IV, Follow-up Study to Evaluate the 17-year Immune Persistence of a Single Dose of Inactivated or Alive Attenuated Hepatitis A Vaccine in Healthy Chinese Participants in the Parent Trial(PRO-HA-4013 )
The purpose of this follow-up study is to evaluate the seventeen-year immune persistence of a single dose of inactivated or attenuated alive hepatitis A vaccine in healthy participants.
Read the detailed description
This study is based on the enrolled population from PRO-HA-4013, a post-marketing trial of Sinovac inactivated hepatitis A vaccine titled "A randomized, double-blind trial comparing inactivated hepatitis A vaccine and lyophilized live attenuated hepatitis A vaccine in healthy young children".
The study sites were the same investigational centers that conducted PRO-HA-4013. Participants for this follow-up study were those who took part in PRO-HA-4013 between June 2008 and September 2013, received trial vaccine, and were included in the FAS analysis set. Eligible participants were enrolled after providing informed consent and screening against inclusion/exclusion criteria. Venous blood specimens were collected from all participants at Year 17 after a single dose of either inactivated hepatitis A vaccine or live attenuated hepatitis A vaccine, and hepatitis A antibody testing was performed to evaluate persistence of immunity after single-dose vaccination.
- Conditions
- Hepatitis A
- Being tested
- Inactivated HAV vaccine, Attenuated live HAV vaccine
- Keywords
- Hepatitis A, immune persistence, inactivated hepatitis A vaccine
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated HAV vaccineBiological
Inactivated hepatitis A vaccine developed by Sinovac Biotech Co., Ltd, per dose containing 250 u antigen, one dose administered in the prior trial.
Attenuated live HAV vaccineBiological
Attenuated alive hepatitis A vaccine, per dose containing 6.50 lgCCID50 alive virus, one dose administered in the prior trial.
| Study group | Role | What they receive |
|---|---|---|
| Inactivated HAV vaccine group | Participants who received a single dose of inactivated hepatitis A vaccine in the PRO-HA-4013 trial. Receives: Biological: Inactivated HAV vaccine | |
| Attenuated alive HAV vaccine group | Participants who received a single dose of freeze-dried attenuated alive hepatitis A vaccine in the PRO-HA-4013 trial. Receives: Biological: Attenuated live HAV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rate of anti-hepatitis A virus (HAV) antibodies in serum at year 17 after vaccination
Evaluate the immune persistence of anti-HAV antibodies in serum 17 years after a single dose of inactivated or attenuated alive hepatitis A vaccine. Seropositivity is defined as anti-HAV antibody concentration ≥ 20 mIU/mL.
Measured: 17 years after vaccination
Geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum at year 17 after vaccination
Evaluate the immune persistence of anti-HAV antibodies in serum 17 years after a single dose of inactivated or attenuated alive hepatitis A vaccine.
Measured: 17 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 posted2 Oct 2026
- Study start13 Jan 2026
- Primary completion9 Mar 2026
- Study completion9 Mar 2026
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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Lin, Principal investigator, Tianjin Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855705
- Sponsor's protocol ID
- PRO-HAV-4013-01
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase IV, Follow-up Study to Evaluate the 17-year Immune Persistence of a Single Dose of Inactivated or Alive Attenuated Hepatitis A Vaccine in Healthy Chinese Participants in the Parent Trial(PRO-HA-4013 )
- ClinicalTrials.gov ID
- NCT07855705
- Acronym / sponsor ID
- PRO-HAV-4013-01
- Conditions
- Hepatitis A
- Keywords
- Hepatitis A, immune persistence, inactivated hepatitis A vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 2 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.
The purpose of this follow-up study is to evaluate the seventeen-year immune persistence of a single dose of inactivated or attenuated alive hepatitis A vaccine in healthy participants.
Detailed description
This study is based on the enrolled population from PRO-HA-4013, a post-marketing trial of Sinovac inactivated hepatitis A vaccine titled "A randomized, double-blind trial comparing inactivated hepatitis A vaccine and lyophilized live attenuated hepatitis A vaccine in healthy young children".
The study sites were the same investigational centers that conducted PRO-HA-4013. Participants for this follow-up study were those who took part in PRO-HA-4013 between June 2008 and September 2013, received trial vaccine, and were included in the FAS analysis set. Eligible participants were enrolled after providing informed consent and screening against inclusion/exclusion criteria. Venous blood specimens were collected from all participants at Year 17 after a single dose of either inactivated hepatitis A vaccine or live attenuated hepatitis A vaccine, and hepatitis A antibody testing was performed to evaluate persistence of immunity after single-dose vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactivated HAV vaccine group | – | Biological: Inactivated HAV vaccineParticipants who received a single dose of inactivated hepatitis A vaccine in the PRO-HA-4013 trial. |
| Attenuated alive HAV vaccine group | – | Biological: Attenuated live HAV vaccineParticipants who received a single dose of freeze-dried attenuated alive hepatitis A vaccine in the PRO-HA-4013 trial. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants who received a single dose of inactivated or live attenuated hepatitis A vaccine in the PRO-HA-4013 trial and were included in the study, aged 18 to 22 years at enrollment.
Key inclusion criteria (3 listed)
- Participants who were included in the Full Analysis Set (FAS) of the PRO-HA-4013 trial;
- Able to understand and voluntarily sign the informed consent form;
- Able to provide legal identification.
Key exclusion criteria (5 listed)
- History of hepatitis A virus infection;
- Receipt of any vaccine containing hepatitis A antigen since participation in the PRO-HA-4013 trial;
- Autoimmune disease or immunodeficiency/immunosuppression;
- Coagulation abnormality (e.g., coagulation factor deficiency, platelet abnormality), or obvious bleeding, hematoma or ecchymosis after prior intramuscular injection or venipuncture;
- Any other condition judged by the investigator to be unsuitable for participation.
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 |
|---|---|---|
| Inactivated HAV vaccineInactivated hepatitis A vaccine developed by Sinovac Biotech Co., Ltd, per dose containing 250 u antigen, one dose administered in the prior trial. | Biological | Inactivated HAV vaccine group |
| Attenuated live HAV vaccineAttenuated alive hepatitis A vaccine, per dose containing 6.50 lgCCID50 alive virus, one dose administered in the prior trial. | Biological | Attenuated alive HAV vaccine group |
Primary outcome
Seropositivity rate of anti-hepatitis A virus (HAV) antibodies in serum at year 17 after vaccination
Time frame: 17 years after vaccination
Evaluate the immune persistence of anti-HAV antibodies in serum 17 years after a single dose of inactivated or attenuated alive hepatitis A vaccine. Seropositivity is defined as anti-HAV antibody concentration ≥ 20 mIU/mL.
Geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum at year 17 after vaccination
Time frame: 17 years after vaccination
Evaluate the immune persistence of anti-HAV antibodies in serum 17 years after a single dose of inactivated or attenuated alive hepatitis A vaccine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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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. This study is not recruiting at the moment.
Li Lin principal investigator
Tianjin 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seropositivity rate of anti-hepatitis A virus (HAV) antibodies in serum at year 17 after vaccination (time frame: 17 years after vaccination). The study lists 2 primary outcomes in all. 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 2 Oct 2026.