Evaluating the safety and immune response of a hepatitis A vaccine in people with HIV

Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People Aged 1-40 Years: A Phase IV Clinical Trial

This study is testing whether a hepatitis A vaccine is safe and effective for people with HIV aged 1 to 40 years.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 1 Year to 40 Years
• Sex: All
• Sponsor: LiuZhou People's Hospital (other)
• Locations: 1 site (Liuzhou, Guangxi)
• Trial ID: NCT06576024 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the immunogenicity and safety of the inactivated hepatitis A vaccine in approximately 400 HIV-infected participants aged 1-40 years. Participants will receive two doses of the vaccine, spaced six months apart, with blood samples collected before and after vaccination to measure antibody responses. Additionally, adverse events will be monitored within one month following each dose. The study will include both immunogenicity and safety assessments, ensuring comprehensive data collection on the vaccine's effects in this population.

Who should consider this trial

Good fit: Ideal candidates for this study are HIV-infected individuals aged 1-40 years with controlled viral loads.

Not a fit: Patients who have previously been vaccinated against hepatitis A or have an active hepatitis A infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of hepatitis A vaccination efficacy in HIV-infected individuals, potentially leading to improved vaccination strategies.

How similar studies have performed: While there have been studies on hepatitis A vaccination in general populations, this specific focus on HIV-infected individuals represents a novel approach.

Eligibility criteria

Inclusion Criteria:

* HIV-infected participants aged 1-40 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

Where this trial is running

Liuzhou, Guangxi

• Liuzhou People's Hospital — Liuzhou, Guangxi, China (RECRUITING)

Study contacts

• Study coordinator: Zhongsheng Jiang

Conditions: Hepatitis A, Immunodeficiency, HIV Infections