Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People
NCT Number: NCT06576024
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hepatitis A|Immunodeficiency|HIV Infections
Interventions: BIOLOGICAL: 2 doses of HAV|BIOLOGICAL: At least one dose of HAV
Sponsor: LiuZhou People's Hospital
Collaborators: Sinovac Biotech Co., Ltd
Sex: ALL
Age: CHILD, ADULT
Enrollment: 400
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-12-19
Completion Date: 2024-12-20
Locations: Liuzhou People's Hospital, Liuzhou, Guangxi, China

Summary:
Approximately 400 HIV-infected participants aged 1-40 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 HAV vaccines with a 6-month interval. Blood samples will be drawn before and 1 month after each dose to detect the HAV anitibodies to evaluate the immunogenicity of the vaccines. Other people will be recruited in the safety study and receive at least one dose of HAV vaccine. All the participants will report the adverse events within one month after each dose.

Primary Outcome Measures: 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 Outcome Measures: GMCs 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|GMIs 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|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, 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, Immunogenicity evaluation, 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, Immunogenicity evaluation, 30 days and 6 months after 1 dose of hepatitis A vaccination|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, 30 days and 6 months after 1 dose of hepatitis A vaccination|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, 30 days and 6 months after 1 dose of hepatitis A vaccination|Incidences of adverse reactions within 7 days after each dose of hepatitis A, safety evaluation, 0-7 days after each dose of hepatitis A vaccination|Incidences of adverse events within 7 days and within 30 days after each dose of hepatitis A vaccination, safety evaluation, 0-7 days and 0-30 days after each dose of hepatitis A vaccination|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, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|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, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|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, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|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, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|The difference in virus loads of HIV before and after vaccination among HIV-infected people, safety evaluation, before and within 1 year after vaccination
Other Outcome Measures: Correlation of T-lymphocyte levels with the pre-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, before vaccination|Correlation of virus titers of HIV with the pre-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, before vaccination|Correlation of age with the pre-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, before vaccination|Correlation of hepatitis B co-infection with the pre-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, before vaccination|Correlation of hepatitis C co-infection with the pre-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, before vaccination|Correlation of ALT levels with the pre-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, before vaccination|Correlation of AST levelswith the pre-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, before vaccination|Correlation of T lymphocyte levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, before vaccination|Correlation of virus titers with the pre-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, before vaccination|Correlation of age with the pre-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, before vaccination|Correlation of hepatitis B co-infection with the pre-vacciantion seropositivity rates of hepatitis A, Immunogenicity evaluation, before vaccination|Correlation of hepatitis C co-infection with the pre-vacciantion seropositivity rates of hepatitis A, Immunogenicity evaluation, before vaccination|Correlation of ALT levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, before vaccination|Correlation of AST levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, before vaccination|Correlation of T-lymphocyte levels with the post-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of virus titers of HIV with the post-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of age with the post-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis B co-infection with the post-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis C co-infection with the post-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of ALT levels with the post-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of AST levels with the post-vacciantion hepatitis A antibodies GMCs, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of T-lymphocyte levels with the post-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of virus titers of HIV with the post-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of age with the post-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis B co-infectionwith the post-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis C co-infectionwith the post-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of ALT levels with the post-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of AST levels with the post-vacciantion seropositivity rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of T-lymphocyte levels with the GMIs of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of virus titers of HIV with GMIs of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of age with the GMIs of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis B co-infection with GMIs of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis C co-infection with GMIs of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of ALT levels with the GMIs of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of AST levels with the GMIs of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of T-lymphocyte levels seroconversion rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of virus titers of HIV with seroconversion rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of age with seroconversion rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis B co-infection with seroconversion rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of hepatitis C co-infection with seroconversion rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of ALT levels with seroconversion rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination|Correlation of AST levels with seroconversion rates of hepatitis A antibodies, Immunogenicity evaluation, 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination