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

NCT06576024 | Completed Phase 4

• 1 other identifier: 2023010-HAVMHYM(IIT)
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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

Immunodeficiency; HIV Infections; Hepatitis A

Outcome Measures

Primary Outcomes (2)

• 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

  30 days after 2 doses of hepatitis A vaccination

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

  safety evaluation

  0-30 days after each dose of hepatitis A vaccination

Secondary Outcomes (14)

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

  30 days after 2 doses of hepatitis A vaccination

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

  30 days after 2 doses of hepatitis A vaccination

• Seropositive rates of anti-HAV antibodies 30 days after 2 doses of hepatitis A vaccination among HIV-infected participants with hepatitis A susceptibility

  30 days after 2 doses of hepatitis A vaccination

• 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

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

• 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

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

Other Outcomes (42)

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

  before vaccination

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

  before vaccination

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

  before vaccination

Study Arms (4)

Participants aged 1-17 years old

EXPERIMENTAL

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

Biological: 2 doses of HAV

HAV susceptible participants aged 18-50 years old

EXPERIMENTAL

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

Biological: 2 doses of HAV

HAV unsusceptible participants aged 18-50 years old

EXPERIMENTAL

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

Biological: 2 doses of HAV

Other participants aged 18-50 years old

EXPERIMENTAL

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

Biological: At least one dose of HAV

Interventions

At least one dose of HAV BIOLOGICAL

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

Other participants aged 18-50 years old

2 doses of HAV BIOLOGICAL

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

HAV susceptible participants aged 18-50 years old; HAV unsusceptible participants aged 18-50 years old; Participants aged 1-17 years old

Eligibility Criteria

• Age: 1 Year - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Vaccines of the same type other than the experimental vaccine were used during the study;
• Any serious adverse reaction that is causally related to the experimental vaccination
• Severe allergic reaction or hypersensitivity reaction after vaccination (including urticaria/rash occurring within 30 minutes after vaccination)

Sponsors & Collaborators

• LiuZhou People's Hospital: lead
• Sinovac Biotech Co., Ltd: collaborator

Study Sites (1)

Liuzhou People's Hospital

Liuchow, Guangxi, China

Location

MeSH Terms

Conditions

Hepatitis A; Immunologic Deficiency Syndromes; HIV Infections

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: August 28, 2024
• Study Start: December 19, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)