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

NCT ID: NCT06576024

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

392 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2025-04-25

Brief Summary

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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

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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

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Hepatitis A Immunodeficiency HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Participants aged 1-17 years old

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

Group Type EXPERIMENTAL

2 doses of HAV

Intervention Type BIOLOGICAL

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

HAV susceptible participants aged 18-50 years old

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

Group Type EXPERIMENTAL

2 doses of HAV

Intervention Type BIOLOGICAL

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

HAV unsusceptible participants aged 18-50 years old

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

Group Type EXPERIMENTAL

2 doses of HAV

Intervention Type BIOLOGICAL

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

Other participants aged 18-50 years old

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

Group Type EXPERIMENTAL

At least one dose of HAV

Intervention Type BIOLOGICAL

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

Interventions

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2 doses of HAV

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

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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


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
Minimum Eligible Age

1 Year

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role collaborator

LiuZhou People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongsheng Jiang

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Liuzhou People's Hospital

Liuchow, Guangxi, China

Site Status

Countries

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China

Other Identifiers

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2023010-HAVMHYM(IIT)

Identifier Type: -

Identifier Source: org_study_id