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This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1 and months 1 and 6.
Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEV vaccine and HBV vaccine Co-administration group | Experimental |
| |
| HEV vaccine control group | Active Comparator |
| |
| HBV vaccine control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEV vaccine | Biological |
| ||
| HBV vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions/events | Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine. And measure the HBsAb in serum samples at 7 month to evaluate the immunogenicity of Hepatitis B vaccine. | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zheng Zhang | Beijing Chaoyang District CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang District CDC | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D016751 | Hepatitis E |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| Biological |
|
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |