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| Name | Class |
|---|---|
| Sinovac Biotech Co., Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants aged 1-17 years old | Experimental | Participants aged 1-17 years old in the immunogenicity and safety study |
|
| HAV susceptible participants aged 18-50 years old | Experimental | HAV susceptible participants aged 18-50 years old in the immunogenicity and safety study |
|
| HAV unsusceptible participants aged 18-50 years old | Experimental | HAV unsusceptible participants aged 18-50 years old in the immunogenicity and safety study |
|
| Other participants aged 18-50 years old | Experimental | Other participants aged 18-50 years old in the safety study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 doses of HAV | Biological | Participants will receive two doses of HAV with a 6-month interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuzhou People's Hospital | Liuzhou | Guangxi | China |
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| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| D007153 | Immunologic Deficiency Syndromes |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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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
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| 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. |
|
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 |
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 |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007154 | Immune System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D045424 |
| Complex Mixtures |