Hepatitis A, HIV Infections, Immunodeficiency
Conditions
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.
Detailed description
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.
Interventions
BIOLOGICAL2 doses of HAV
Participants will receive two doses of HAV with a 6-month interval
BIOLOGICALAt 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
Sinovac Biotech Co., Ltd
LiuZhou People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
1 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate 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 | Immunogenicity evaluation |
| Incidences of adverse reactions within 30 days after each dose of hepatitis A vaccination | 0-30 days after each dose of hepatitis A vaccination | safety evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Immunogenicity evaluation |
| 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 | Immunogenicity evaluation |
| 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 | Immunogenicity evaluation |
| 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 | 30 days and 6 months after 1 dose of hepatitis A vaccination | Immunogenicity evaluation |
| 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 | 30 days and 6 months after 1 dose of hepatitis A vaccination | Immunogenicity evaluation |
| Incidences of adverse reactions within 7 days after each dose of hepatitis A | 0-7 days after each dose of hepatitis A vaccination | safety evaluation |
| 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 | Immunogenicity evaluation |
| 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 | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| 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 | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| 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 | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| 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 | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| The difference in virus loads of HIV before and after vaccination among HIV-infected people | before and within 1 year after vaccination | safety evaluation |
| Incidences of adverse events within 7 days and within 30 days after each dose of hepatitis A vaccination | 0-7 days and 0-30 days after each dose of hepatitis A vaccination | safety evaluation |
| 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 | Immunogenicity evaluation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of age with the post-vacciantion hepatitis A antibodies GMCs | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis B co-infection with the post-vacciantion hepatitis A antibodies GMCs | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis C co-infection with the post-vacciantion hepatitis A antibodies GMCs | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of ALT levels with the post-vacciantion hepatitis A antibodies GMCs | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of AST levels with the post-vacciantion hepatitis A antibodies GMCs | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of T-lymphocyte levels with the post-vacciantion seropositivity rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of virus titers of HIV with the post-vacciantion seropositivity rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of age with the post-vacciantion seropositivity rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis B co-infectionwith the post-vacciantion seropositivity rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis C co-infectionwith the post-vacciantion seropositivity rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of ALT levels with the post-vacciantion seropositivity rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of AST levels with the post-vacciantion seropositivity rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of T-lymphocyte levels with the GMIs of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of virus titers of HIV with GMIs of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of age with the GMIs of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis B co-infection with GMIs of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis C co-infection with GMIs of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of ALT levels with the GMIs of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of AST levels with the GMIs of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of T-lymphocyte levels seroconversion rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of T-lymphocyte levels with the pre-vacciantion hepatitis A antibodies GMCs | before vaccination | Immunogenicity evaluation |
| Correlation of age with seroconversion rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis B co-infection with seroconversion rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of hepatitis C co-infection with seroconversion rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of ALT levels with seroconversion rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of AST levels with seroconversion rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of virus titers of HIV with seroconversion rates of hepatitis A antibodies | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of virus titers of HIV with the pre-vacciantion hepatitis A antibodies GMCs | before vaccination | Immunogenicity evaluation |
| Correlation of age with the pre-vacciantion hepatitis A antibodies GMCs | before vaccination | Immunogenicity evaluation |
| Correlation of hepatitis B co-infection with the pre-vacciantion hepatitis A antibodies GMCs | before vaccination | Immunogenicity evaluation |
| Correlation of hepatitis C co-infection with the pre-vacciantion hepatitis A antibodies GMCs | before vaccination | Immunogenicity evaluation |
| Correlation of ALT levels with the pre-vacciantion hepatitis A antibodies GMCs | before vaccination | Immunogenicity evaluation |
| Correlation of AST levelswith the pre-vacciantion hepatitis A antibodies GMCs | before vaccination | Immunogenicity evaluation |
| Correlation of T lymphocyte levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies | before vaccination | Immunogenicity evaluation |
| Correlation of virus titers with the pre-vacciantion seropositivity rates of hepatitis A antibodies | before vaccination | Immunogenicity evaluation |
| Correlation of age with the pre-vacciantion seropositivity rates of hepatitis A antibodies | before vaccination | Immunogenicity evaluation |
| Correlation of hepatitis B co-infection with the pre-vacciantion seropositivity rates of hepatitis A | before vaccination | Immunogenicity evaluation |
| Correlation of hepatitis C co-infection with the pre-vacciantion seropositivity rates of hepatitis A | before vaccination | Immunogenicity evaluation |
| Correlation of ALT levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies | before vaccination | Immunogenicity evaluation |
| Correlation of AST levels with the pre-vacciantion seropositivity rates of hepatitis A antibodies | before vaccination | Immunogenicity evaluation |
| Correlation of T-lymphocyte levels with the post-vacciantion hepatitis A antibodies GMCs | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
| Correlation of virus titers of HIV with the post-vacciantion hepatitis A antibodies GMCs | 30 days after 1 dose, 30 days and 6 months after 2 doses of hepatitis A vaccination | Immunogenicity evaluation |
Countries
China
Outcome results
None listed