HIV patients get hepatitis a vaccine: does it work?
NCT ID NCT06576024
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how safe and effective a hepatitis A vaccine is for people with HIV, aged 1 to 50. About 392 participants received two vaccine doses six months apart. Researchers checked their blood for antibodies and tracked any side effects for a month after each dose. The goal was to see if the vaccine triggers a strong immune response in this group.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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392 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Apr 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 Exclusion Criteria of second 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. 1. Vaccines of the same type other than the experimental vaccine were used during the study; 2. Any serious adverse reaction that is causally related to the experimental vaccination 3. Severe allergic reaction or hypersensitivity reaction after vaccination (including urticaria/rash occurring within 30 minutes after vaccination) 4. Pregnant after the first vaccination (those who had positive result for urine pregnancy test or those who are known to be pregnant) 5. Acute or recently diagnosed chronic disease that occurred after the first vaccination 6. 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 7. Suffering from acute illness (acute illness refers to moderate or severe illness with or without fever); 8. Axillary temperature ≥37.3℃ during vaccination; 9. Have received subunit vaccine or inactivated vaccine within 7 days, and have received live attenuated vaccine within 14 days 10. According to the investigator's judgment, participants who has any other factors that make him or her unsuitable for vaccination
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Liuzhou People's Hospital
Liuzhou, Guangxi, China
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Other studies related to the condition(s) this trial covers.
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