NCT06576024CompletedPhase 4
Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People
Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People Aged 1-50 Years: A Phase IV Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 392 (actual)
- First submitted
- 20 Mar 2024
- Start date
- 19 Dec 2023
- Primary completion date
- 25 Apr 2025
- Lead sponsor
- LiuZhou People's Hospital
- Diseases
- HIV
- NCT number
- NCT06576024
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 392
- From 19 Dec 2023 to the primary completion date, 25 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Vaccines of the same type other than the experimental vaccine were used during the study;
- Have received subunit vaccine or inactivated vaccine within 7 days, and have received live attenuated vaccine within 14 days
Other illness
- 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.)
- 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
- Severe allergic reaction or hypersensitivity reaction after vaccination (including urticaria/rash occurring within 30 minutes after vaccination)
- Acute or recently diagnosed chronic disease that occurred after the first vaccination
- Suffering from acute illness (acute illness refers to moderate or severe illness with or without fever);
Other
- Pregnant women and lactating women
- 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.
- Any serious adverse reaction that is causally related to the experimental vaccination
- Pregnant after the first vaccination (those who had positive result for urine pregnancy test or those who are known to be pregnant)
- 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
- Axillary temperature ≥37.3℃ during vaccination;
- According to the investigator's judgment, participants who has any other factors that make him or her unsuitable for vaccination
Who the study is looking for
- 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
Age in the registry: 1 year to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.