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

NCT06576024 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2025-12-31

No results posted yet for this 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.

Conditions

  • Hepatitis A
  • Immunodeficiency
  • HIV Infections

Interventions

BIOLOGICAL

2 doses of HAV

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

BIOLOGICAL

At least one dose of HAV

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

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    collaborator INDUSTRY

  • LiuZhou People's Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2025-04-25
Completion
2025-04-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576024 on ClinicalTrials.gov