Hepatitis APhase 4NCT06576024
Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People
A Phase 4 study testing 2 doses of HAV and At least one dose of HAV in people with Hepatitis A and Immunodeficiency, run by LiuZhou People's Hospital at 1 site in China.
Trial summary
Approximately 400 HIV-infected participants aged 1-50 years old will be recruited according to the inclusion and exclusion criteria. Among them, more than 180 participants will be recruited in the immunogenicity and safety study. Each of them will receive 2 doses of the HAV vaccine with a 6-month interval. Read more about this study
- Who is it for?
- Ages 1 year to 50 years
- Conditions the study is for
- Hepatitis A, Immunodeficiency, HIV Infections
- What is being tested?
- 2 doses of HAV and At least one dose of HAV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2023to 25 Apr 2025
- Phase
- Phase 4
- 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 1 year to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV-infected participants aged 1-50 years old
- The HIV viral loads of participants in the past 12 months were supposed to be less than 200 copies/ml
- Participants or his/her guardian can fully understand and voluntarily sign the informed consent 4. Participants who are willing to participate in the 7-month follow-up 5. Participants who can provide valid legal identification
Who cannot join
- Participants who have infected with hepatitis A;
- Participants who have been vaccinated with inactivated or live-attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine
- Participants who are allergic constitution or severe allergic to vaccines or components 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.)
- Participants with fever (axillary temperature ≥37.3℃) during vaccination, or acute exacerbation of chronic diseases, or participants with uncontrolled severe chronic diseases, or suffering from acute diseases
Show all 22Show fewer
- Participants who have received other experimental drugs within 30 days before vaccination with the experimental vaccine
- Participants who have received live-attenuated vaccine withins 14 days before vaccination with the experimental vaccine
- Participants who have received subunit or inactivated vaccines within 7 days before vaccination with experimental vaccine
- According to the investigator's judgment, participants who has any other factors that make him or her unsuitable for vaccination
- Participants who meet one of the following events (1) to (4), should not receive the second vaccination, but can continue other study steps according to the investigator's judgment; if participants who meet one of the following events (5) or (6), can still receive the second vaccination according to the investigator's judgment.
- Participants who meet one of the following events (7) to (10) can postponed the second vaccination within the time window specified in the protocal.
- Vaccines of the same type other than the experimental vaccine were used during the study;
- Any serious adverse reaction that is causally related to the experimental vaccination
- Severe allergic reaction or hypersensitivity reaction after vaccination (including urticaria/rash occurring within 30 minutes after vaccination)
- Pregnant after the first vaccination (those who had positive result for urine pregnancy test or those who are known to be pregnant)
- Acute or recently diagnosed chronic disease that occurred after the first vaccination
- Other reactions (including severe pain, severe swelling, severe limitation of activity, persistent high fever, severe headache, or other systemic or local reactions) are diagonosed by investigator
- Suffering from acute illness (acute illness refers to moderate or severe illness with or without fever);
- Axillary temperature ≥37.3℃ during vaccination;
- Have received subunit vaccine or inactivated vaccine within 7 days, and have received live attenuated vaccine within 14 days
- According to the investigator's judgment, participants who has any other factors that make him or her unsuitable for vaccination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People Aged 1-50 Years: A Phase IV Clinical Trial
Approximately 400 HIV-infected participants aged 1-50 years old will be recruited according to the inclusion and exclusion criteria. Among them, more than 180 participants will be recruited in the immunogenicity and safety study. Each of them will receive 2 doses of the HAV vaccine with a 6-month interval. Blood samples will be drawn before and 1 month after each dose to detect the HAV antibodies to evaluate the immunogenicity of the vaccines. Other people will be recruited in the safety study and receive at least one dose of the HAV vaccine. All the participants will report the adverse events within one month after each dose.
Read the detailed description
Approximately 400 HIV-infected participants aged 1-50 years old will be recruited in terms of inclusion and exclusion criteria. All participants will receive one dose of the hepatitis A vaccine and have their blood and urine samples collected before and after vaccination for laboratory-related indicator testing. At least 120 HAV-susceptible participants (with anti-HAV antibodies negative before vaccination) and 60 HAV-unsusceptible participants (with anti-HAV antibodies positive before vaccination) aged 18-50 years old, and an unlimited number of HIV-infected children aged 1-17 years old will be included into immunogenicity study, with rest participants included into safety study. Participants in immunogenicity study will receive the second dose of hepatitis A vaccination with a 6-month interval. Blood and urine samples will be collected 1 month, 6months (before second vaccination), and 7 months (1month after second vaccination) after the first vaccination. Participants in safety study will receive second vaccination voluntarily. Adverse events in both immunogenicity and safety study will be collected within 30 days after each dose of vaccination using smartphone mini program or diary cards.
- Conditions
- Hepatitis A, Immunodeficiency, HIV Infections
- Being tested
- 2 doses of HAV, At least one dose of HAV
- Medical subject headings
- Hepatitis A, Immunologic Deficiency Syndromes, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 doses of HAVBiological
Participants will receive two doses of HAV with a 6-month interval
At least one dose of HAVBiological
Participants will receive the first dose of HAV and willreceive the second dose with a 6 -month interval voluntarily.
| Study group | Role | What they receive |
|---|---|---|
| Participants aged 1-17 years old | Experimental | Participants aged 1-17 years old in the immunogenicity and safety study Receives: Biological: 2 doses of HAV |
| HAV susceptible participants aged 18-50 years old | Experimental | HAV susceptible participants aged 18-50 years old in the immunogenicity and safety study Receives: Biological: 2 doses of HAV |
| HAV unsusceptible participants aged 18-50 years old | Experimental | HAV unsusceptible participants aged 18-50 years old in the immunogenicity and safety study Receives: Biological: 2 doses of HAV |
| Other participants aged 18-50 years old | Experimental | Other participants aged 18-50 years old in the safety study Receives: Biological: At least one dose of HAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days after 2 doses of hepatitis A vaccination
Incidences of adverse reactions within 30 days after each dose of hepatitis A vaccination
safety evaluation
Measured: 0-30 days after each dose of hepatitis A vaccination
Secondary outcomes (14)
GMCs of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days after 2 doses of hepatitis A vaccination
GMIs of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days after 2 doses of hepatitis A vaccination
Seropositive rates of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days after 2 doses of hepatitis A vaccination
Seroconversion rates of anti-HAV antibodies 30 days and 6 months after the first dose of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days and 6 months after one dose of hepatitis A vaccination
Seropositive rates of anti-HAV antibodies 30 days and 6 months after 1 dose of hepatitis A vaccination among HIV-infected participants without hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days and 6 months after 1 dose of hepatitis A vaccination
GMCs of anti-HAV antibodies 30 days and 6 months after 1 dose of hepatitis A vaccination among HIV-infected participants without hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days and 6 months after 1 dose of hepatitis A vaccination
GMIs of anti-HAV antibodies 30 days and 6 months after 1 dose of hepatitis A vaccination among HIV-infected participants without hepatitis A susceptibility
Immunogenicity evaluation
Measured: 30 days and 6 months after 1 dose of hepatitis A vaccination
Incidences of adverse reactions within 7 days after each dose of hepatitis A
safety evaluation
Measured: 0-7 days after each dose of hepatitis A vaccination
Incidences of adverse events within 7 days and within 30 days after each dose of hepatitis A vaccination
safety evaluation
Measured: 0-7 days and 0-30 days after each dose of hepatitis A vaccination
Seroconversion rates of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Immunogenicity evaluation
Measured: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
Seropositive rates of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Immunogenicity evaluation
Measured: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
GMC of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Immunogenicity evaluation
Measured: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
GMIs of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Immunogenicity evaluation
Measured: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
The difference in virus loads of HIV before and after vaccination among HIV-infected people
safety evaluation
Measured: before and within 1 year after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start19 Dec 2023
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study aims to evaluate the immunogenicity and safety of hepatitis A vaccine in HIV-infected people, thus the vaccine is considered to be a kind of intervention. We divided HIV-infected people into different groups according to their HIV virus loads to make comparison
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- LiuZhou People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sinovac Biotech Co., Ltd
- Responsible party
- Principal investigator, Zhongsheng Jiang, LiuZhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576024
- Sponsor's protocol ID
- 2023010-HAVMHYM(IIT)
- Status last verified
- Dec 2025
- First submitted
- 20 Mar 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People Aged 1-50 Years: A Phase IV Clinical Trial
- ClinicalTrials.gov ID
- NCT06576024
- Acronym / sponsor ID
- 2023010-HAVMHYM(IIT)
- Conditions
- Hepatitis A, Immunodeficiency, HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- LiuZhou People's HospitalUniversity, hospital or other
- Collaborators
- Sinovac Biotech Co., Ltd
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 28 Aug 2024 (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.
Approximately 400 HIV-infected participants aged 1-50 years old will be recruited according to the inclusion and exclusion criteria. Among them, more than 180 participants will be recruited in the immunogenicity and safety study. Each of them will receive 2 doses of the HAV vaccine with a 6-month interval. Blood samples will be drawn before and 1 month after each dose to detect the HAV antibodies to evaluate the immunogenicity of the vaccines. Other people will be recruited in the safety study and receive at least one dose of the HAV vaccine. All the participants will report the adverse events within one month after each dose.
Detailed description
Approximately 400 HIV-infected participants aged 1-50 years old will be recruited in terms of inclusion and exclusion criteria. All participants will receive one dose of the hepatitis A vaccine and have their blood and urine samples collected before and after vaccination for laboratory-related indicator testing. At least 120 HAV-susceptible participants (with anti-HAV antibodies negative before vaccination) and 60 HAV-unsusceptible participants (with anti-HAV antibodies positive before vaccination) aged 18-50 years old, and an unlimited number of HIV-infected children aged 1-17 years old will be included into immunogenicity study, with rest participants included into safety study. Participants in immunogenicity study will receive the second dose of hepatitis A vaccination with a 6-month interval. Blood and urine samples will be collected 1 month, 6months (before second vaccination), and 7 months (1month after second vaccination) after the first vaccination. Participants in safety study will receive second vaccination voluntarily. Adverse events in both immunogenicity and safety study will be collected within 30 days after each dose of vaccination using smartphone mini program or diary cards.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study aims to evaluate the immunogenicity and safety of hepatitis A vaccine in HIV-infected people, thus the vaccine is considered to be a kind of intervention. We divided HIV-infected people into different groups according to their HIV virus loads to make comparison
| Arm | Type | Receives |
|---|---|---|
| Participants aged 1-17 years old | Experimental | Biological: 2 doses of HAVParticipants aged 1-17 years old in the immunogenicity and safety study |
| HAV susceptible participants aged 18-50 years old | Experimental | Biological: 2 doses of HAVHAV susceptible participants aged 18-50 years old in the immunogenicity and safety study |
| HAV unsusceptible participants aged 18-50 years old | Experimental | Biological: 2 doses of HAVHAV unsusceptible participants aged 18-50 years old in the immunogenicity and safety study |
| Other participants aged 18-50 years old | Experimental | Biological: At least one dose of HAVOther participants aged 18-50 years old in the safety study |
Who may qualify
- Ages
- 1 year to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- HIV-infected participants aged 1-50 years old
- The HIV viral loads of participants in the past 12 months were supposed to be less than 200 copies/ml
- Participants or his/her guardian can fully understand and voluntarily sign the informed consent 4. Participants who are willing to participate in the 7-month follow-up 5. Participants who can provide valid legal identification
Key exclusion criteria (22 listed)
- Participants who have infected with hepatitis A;
- Participants who have been vaccinated with inactivated or live-attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine
- Participants who are allergic constitution or severe allergic to vaccines or components 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.)
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 |
|---|---|---|
| 2 doses of HAVParticipants will receive two doses of HAV with a 6-month interval | Biological | HAV susceptible participants aged 18-50 years old, HAV unsusceptible participants aged 18-50 years old, Participants aged 1-17 years old |
| At least one dose of HAVParticipants will receive the first dose of HAV and willreceive the second dose with a 6 -month interval voluntarily. | Biological | Other participants aged 18-50 years old |
Primary outcome
Seroconversion rate of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Time frame: 30 days after 2 doses of hepatitis A vaccination
Immunogenicity evaluation
Incidences of adverse reactions within 30 days after each dose of hepatitis A vaccination
Time frame: 0-30 days after each dose of hepatitis A vaccination
safety evaluation
14 secondary outcomes
GMCs of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Time frame: 30 days after 2 doses of hepatitis A vaccination
GMIs of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Time frame: 30 days after 2 doses of hepatitis A vaccination
Seropositive rates of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Time frame: 30 days after 2 doses of hepatitis A vaccination
Seroconversion rates of anti-HAV antibodies 30 days and 6 months after the first dose of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility
Time frame: 30 days and 6 months after one dose of hepatitis A vaccination
Seropositive rates of anti-HAV antibodies 30 days and 6 months after 1 dose of hepatitis A vaccination among HIV-infected participants without hepatitis A susceptibility
Time frame: 30 days and 6 months after 1 dose of hepatitis A vaccination
GMCs of anti-HAV antibodies 30 days and 6 months after 1 dose of hepatitis A vaccination among HIV-infected participants without hepatitis A susceptibility
Time frame: 30 days and 6 months after 1 dose of hepatitis A vaccination
GMIs of anti-HAV antibodies 30 days and 6 months after 1 dose of hepatitis A vaccination among HIV-infected participants without hepatitis A susceptibility
Time frame: 30 days and 6 months after 1 dose of hepatitis A vaccination
Incidences of adverse reactions within 7 days after each dose of hepatitis A
Time frame: 0-7 days after each dose of hepatitis A vaccination
Incidences of adverse events within 7 days and within 30 days after each dose of hepatitis A vaccination
Time frame: 0-7 days and 0-30 days after each dose of hepatitis A vaccination
Seroconversion rates of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
Seropositive rates of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
GMC of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
GMIs of anti-HAV antibodies 30 days after 1 does, 30 days and 6 months after 2 doses of hepatitis A vaccination among HIV-infected participants with anti-HAV antibodies seropositivity
Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination
The difference in virus loads of HIV before and after vaccination among HIV-infected people
Time frame: before and within 1 year after vaccination
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 31 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2 doses of HAV and At least one dose of HAV in people with Hepatitis A and Immunodeficiency, run by LiuZhou People's Hospital 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 22 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 31 Dec 2025. 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?
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?
Seroconversion rate of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility (time frame: 30 days after 2 doses of hepatitis A 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 31 Dec 2025.