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| Name | Class |
|---|---|
| Liaoning Center for Disease Control and Prevention | OTHER |
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This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunogenicity group with vaccination interval of 6 month | Other |
| |
| immunogenicity group with vaccination interval of 18 month | Other |
| |
| immunogenicity group with vaccination interval of 36 month | Other |
| |
| immunogenicity group with vaccination interval of 60 month | Other |
| |
| safety observation group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healive (hepatitis A vacine(human diploid cell), inactivated) | Biological | The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month | 28 days after two dose of vaccination of hepatitis A vaccine | |
| Incidence of adverse reaction within 28 days after one dose of vaccination | 28 days after one dose of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 18 month, 36 months, and 60 months | 28 days after two dose of vaccination | |
| The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaoning Center for Disease Control and Prevention | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25969561 | Background | Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12. | |
| 15109480 | Background |
| Label | URL |
|---|---|
| ACIP | View source |
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| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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|
| 28th day after two dose of vaccination |
| The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after one dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months | 28 days after one dose of vaccination |
| The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months among people with underlying conditions | 28 days after two dose of vaccination |
| The seropositive rate of anti-HAV antibody before vaccination | before vaccination |
| Incidence of adverse reaction within 7 days after one dose of vaccination | 7 days after one dose of vaccination |
| Incidence of adverse reaction within 28 days after two dose of vaccination | 28 days after two dose of vaccination |
| Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people | 28 days after one dose of vaccination among |
| Iwarson S, Lindh M, Widerstrom L. Excellent booster response 4 to 8 years after a single primary dose of an inactivated hepatitis A vaccine. J Travel Med. 2004 Mar-Apr;11(2):120-1. doi: 10.2310/7060.2004.17079. No abstract available. |
| WHO position paper on hepatitis A vaccines-October2022 | View source |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |