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Hepatitis APhase 4NCT06058416

Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old

A Phase 4 study testing Healive (hepatitis A vacine(human diploid cell), inactivated) in people with Hepatitis A, run by Sinovac Biotech Co., Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis A
What is being tested?
Healive (hepatitis A vacine(human diploid cell), inactivated)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,092 participants
Where
1 siteChina
Study dates
24 Oct 2023to 31 Dec 2029
Phase
Phase 4
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adults aged 18-50;
  • Adults can understand and sign the informed consent form voluntarily;
  • Adults can provide valid and legal identity certificate.

Who cannot join

  • A history of hepatitis A infection;
  • Previously vaccinated with inactivated hepatitis A vaccine, live attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine;
  • Allergic constitution or have severe allergic reaction to vaccines in the past (such as acute allergic reaction, angioedema, dyspnea, etc.);
  • Pregnant women and lactating women;
  • People suffering from uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases, etc.);
  • Patients with fever during vaccination, or acute exacerbation of chronic diseases, or patients with uncontrolled severe chronic diseases, or suffering from acute diseases;
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  • Received other research drugs within 30 days before vaccination with the experimental vaccine;
  • Have received a live attenuated vaccine within 14 days before vaccination with the experimental vaccine;
  • Have received subunit or inactivated vaccine within 7 days before vaccination with experimental vaccine;
  • Other conditions that are not suitable for vaccination judged by the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Liaoning Center for Disease Control and Prevention

    Shenyang, Liaoning

Other trials in China

About this study

Official title: The Immunogenicity and Safety of Different Vaccination Interval of Inactivated Hepatitis A Vaccine in People Aged 18-50 Years, a Phase IV Clinical Trial

This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.

Conditions
Hepatitis A
Being tested
Healive (hepatitis A vacine(human diploid cell), inactivated)
Keywords
immunogenicity and safety of vaccine, hepatitis A vaccine, vaccination schedule
Medical subject headings
Hepatitis A, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healive (hepatitis A vacine(human diploid cell), inactivated)Biological

    The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution.

    For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.

Study groups in NCT06058416
Study groupRoleWhat they receive
immunogenicity group with vaccination interval of 6 monthOtherNot described
Receives: Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)
immunogenicity group with vaccination interval of 18 monthOtherNot described
Receives: Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)
immunogenicity group with vaccination interval of 36 monthOtherNot described
Receives: Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)
immunogenicity group with vaccination interval of 60 monthOtherNot described
Receives: Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)
safety observation groupOtherNot described
Receives: Biological: Healive (hepatitis A vacine(human diploid cell), inactivated)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month

    Measured: 28 days after two dose of vaccination of hepatitis A vaccine

  2. Incidence of adverse reaction within 28 days after one dose of vaccination

    Measured: 28 days after one dose of vaccination

Secondary outcomes (8)

  1. The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 18 month, 36 months, and 60 months

    Measured: 28 days after two dose of vaccination

  2. The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months

    Measured: 28th day after two dose of vaccination

  3. The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after one dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months

    Measured: 28 days after one dose of vaccination

  4. The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months among people with underlying conditions

    Measured: 28 days after two dose of vaccination

  5. The seropositive rate of anti-HAV antibody before vaccination

    Measured: before vaccination

  6. Incidence of adverse reaction within 7 days after one dose of vaccination

    Measured: 7 days after one dose of vaccination

  7. Incidence of adverse reaction within 28 days after two dose of vaccination

    Measured: 28 days after two dose of vaccination

  8. Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people

    Measured: 28 days after one dose of vaccination among

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start24 Oct 2023
  3. Primary completion17 Mar 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
1,092 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06058416
Sponsor's protocol ID
PRO-HAV-MA4001-LN
Status last verified
Aug 2024
First submitted
21 Sep 2023
Last updated
21 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12.

    PubMed 25969561

  • Iwarson S, Lindh M, Widerstrom L. Excellent booster response 4 to 8 years after a single primary dose of an inactivated hepatitis A vaccine. J Travel Med. 2004 Mar-Apr;11(2):120-1. doi: 10.2310/7060.2004.17079. No abstract available.

    PubMed 15109480

  • Chang L, Li Z, Liu Y, Fei S, Zhao L, Li J, Huang W, Yang Y, Tuo L, Feng B, Wu X, Zhao Y, Li J, Fang X. Immunogenicity and safety of hepatitis A vaccine at different vaccination intervals among adults aged 18 years and above: Interim results. Hum Vaccin Immunother. 2025 Dec;21(1):2506294. doi: 10.1080/21645515.2025.2506294. Epub 2025 May 20.

    PubMed 40391688

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Healive (hepatitis A vacine(human diploid cell), inactivated) in people with 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 10 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month (time frame: 28 days after two dose of vaccination of hepatitis A vaccine). 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?

On the ClinicalTrials.gov record for NCT06058416, which also lists 3 linked publications.

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 21 Aug 2024.

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