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CompletedNCT06576024Updated Dec 31, 2025

Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People

A Phase 4 interventional study of 2 doses of HAV and At least one dose of HAV in Hepatitis A, Immunodeficiency and HIV Infections, sponsored by LiuZhou People's Hospital. Completed at 1 site in China. Open to participants aged 1 Year to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by LiuZhou People's Hospital · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2023, registered Mar 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
392
Allocation
Non-randomized
Ages
1 Year to 50 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hepatitis A
  • Immunodeficiency
  • HIV Infections
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 392 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

LiuZhou People's Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
392 participants (actual)

Study arms

  • Experimental
    Participants aged 1-17 years old

    Participants aged 1-17 years old in the immunogenicity and safety study

    Biological: 2 doses of HAV

  • Experimental
    HAV susceptible participants aged 18-50 years old

    HAV susceptible participants aged 18-50 years old in the immunogenicity and safety study

    Biological: 2 doses of HAV

  • Experimental
    HAV unsusceptible participants aged 18-50 years old

    HAV unsusceptible participants aged 18-50 years old in the immunogenicity and safety study

    Biological: 2 doses of HAV

  • Experimental
    Other participants aged 18-50 years old

    Other participants aged 18-50 years old in the safety study

    Biological: At least one dose of HAV

Interventions

  • Biological2 doses of HAV

    Participants will receive two doses of HAV with a 6-month interval

  • BiologicalAt least one dose of HAV

    Participants will receive the first dose of HAV and willreceive the second dose with a 6 -month interval voluntarily.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days after 2 doses of hepatitis A vaccination

  2. Incidences of adverse reactions within 30 days after each dose of hepatitis A vaccination

    safety evaluation

    Time frame: 0-30 days after each dose of hepatitis A vaccination

Secondary outcomes

  1. GMCs of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility

    Immunogenicity evaluation

    Time frame: 30 days after 2 doses of hepatitis A vaccination

  2. GMIs of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility

    Immunogenicity evaluation

    Time frame: 30 days after 2 doses of hepatitis A vaccination

  3. 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

    Time frame: 30 days after 2 doses of hepatitis A vaccination

  4. 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

    Time frame: 30 days and 6 months after one dose of hepatitis A vaccination

  5. 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

    Time frame: 30 days and 6 months after 1 dose of hepatitis A vaccination

  6. 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

    Time frame: 30 days and 6 months after 1 dose of hepatitis A vaccination

  7. 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

    Time frame: 30 days and 6 months after 1 dose of hepatitis A vaccination

  8. Incidences of adverse reactions within 7 days after each dose of hepatitis A

    safety evaluation

    Time frame: 0-7 days after each dose of hepatitis A vaccination

  9. Incidences of adverse events within 7 days and within 30 days after each dose of hepatitis A vaccination

    safety evaluation

    Time frame: 0-7 days and 0-30 days after each dose of hepatitis A vaccination

  10. 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

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  11. 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

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  12. 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

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  13. 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

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  14. The difference in virus loads of HIV before and after vaccination among HIV-infected people

    safety evaluation

    Time frame: before and within 1 year after vaccination

Other outcomes

  1. Correlation of T-lymphocyte levels with the pre-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: before vaccination

  2. Correlation of virus titers of HIV with the pre-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: before vaccination

  3. Correlation of age with the pre-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: before vaccination

  4. Correlation of hepatitis B co-infection with the pre-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: before vaccination

  5. Correlation of hepatitis C co-infection with the pre-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: before vaccination

  6. Correlation of ALT levels with the pre-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: before vaccination

  7. Correlation of AST levelswith the pre-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: before vaccination

  8. Correlation of T lymphocyte levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: before vaccination

  9. Correlation of virus titers with the pre-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: before vaccination

  10. Correlation of age with the pre-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: before vaccination

  11. Correlation of hepatitis B co-infection with the pre-vacciantion seropositivity rates of hepatitis A

    Immunogenicity evaluation

    Time frame: before vaccination

  12. Correlation of hepatitis C co-infection with the pre-vacciantion seropositivity rates of hepatitis A

    Immunogenicity evaluation

    Time frame: before vaccination

  13. Correlation of ALT levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: before vaccination

  14. Correlation of AST levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: before vaccination

  15. Correlation of T-lymphocyte levels with the post-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  16. Correlation of virus titers of HIV with the post-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  17. Correlation of age with the post-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  18. Correlation of hepatitis B co-infection with the post-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  19. Correlation of hepatitis C co-infection with the post-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  20. Correlation of ALT levels with the post-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  21. Correlation of AST levels with the post-vacciantion hepatitis A antibodies GMCs

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  22. Correlation of T-lymphocyte levels with the post-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  23. Correlation of virus titers of HIV with the post-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  24. Correlation of age with the post-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  25. Correlation of hepatitis B co-infectionwith the post-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  26. Correlation of hepatitis C co-infectionwith the post-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  27. Correlation of ALT levels with the post-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  28. Correlation of AST levels with the post-vacciantion seropositivity rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  29. Correlation of T-lymphocyte levels with the GMIs of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  30. Correlation of virus titers of HIV with GMIs of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  31. Correlation of age with the GMIs of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  32. Correlation of hepatitis B co-infection with GMIs of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  33. Correlation of hepatitis C co-infection with GMIs of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  34. Correlation of ALT levels with the GMIs of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  35. Correlation of AST levels with the GMIs of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  36. Correlation of T-lymphocyte levels seroconversion rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  37. Correlation of virus titers of HIV with seroconversion rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  38. Correlation of age with seroconversion rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  39. Correlation of hepatitis B co-infection with seroconversion rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  40. Correlation of hepatitis C co-infection with seroconversion rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  41. Correlation of ALT levels with seroconversion rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

  42. Correlation of AST levels with seroconversion rates of hepatitis A antibodies

    Immunogenicity evaluation

    Time frame: 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination

07

Study locations

1 site
  • Liuzhou People's Hospital
    Liuzhou, Guangxi, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06576024
Lead sponsor
LiuZhou People's Hospital
Collaborators
Sinovac Biotech Co., Ltd
Responsible party
Zhongsheng Jiang (Chief physician, LiuZhou People's Hospital) — Principal investigator
First posted
Aug 28, 2024
Start date
Dec 19, 2023
Primary completion
Apr 25, 2025
Completion
Apr 25, 2025
Last update
Dec 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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