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This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine (HecolinĀ®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers will receive the 3 doses of HecolinĀ® administered intramuscularly according to a 0-7-21 days schedule or a 0-1-6 month schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Accelerated Vaccination Schedule Group | Experimental | Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(HecolinĀ®) at 0,7,21 day. |
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| the Standard Vaccination Schedule Group | Active Comparator | Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(HecolinĀ®) at 0,1,6 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Hepatitis E Vaccine (Escherichia Coli) | Biological | Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 7, 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HEV antibody of Experimental Group | Measure anti-HEV antibody in serum samples at 51st day to evaluate the immunogenicity of the Hepatitis E vaccine. | up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions/events of Experimental Group and Control Group | Measure solicited local adverse reactions/events within 7 days after each vaccination; Measure solicited systematic adverse reactions/events within 7 days after each vaccination; Measure unsolicited adverse reactions/events within 30 days after vaccination; Measure serious adverse events occurred throughout the studyļ¼up to 7 monthsļ¼. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiping Chen | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changshan Center for Disease Control and Prevention | Quzhou | Zhejiang | 324200 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30711651 | Derived | Chen Z, Lin S, Duan J, Luo Y, Wang S, Gan Z, Yi H, Wu T, Huang S, Zhang Q, Lv H. Immunogenicity and safety of an accelerated hepatitis E vaccination schedule in healthy adults: a randomized, controlled, open-label, phase IV trial. Clin Microbiol Infect. 2019 Sep;25(9):1133-1139. doi: 10.1016/j.cmi.2019.01.015. Epub 2019 Jan 31. |
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| ID | Term |
|---|---|
| D016751 | Hepatitis E |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C577000 | hecolin |
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| Recombinant Hepatitis E Vaccine (Escherichia Coli) | Biological | Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. |
|
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| up to 7 months |
| Anti-HEV antibody of Experimental Group | Measure anti-HEV antibody in serum samples at 21st day,28st day and month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. | up to 7 months |
| Anti-HEV antibody of Control Group | Measure anti-HEV antibody in serum samples at month 1,2,7 to evaluate the immunogenicity of the Hepatitis E vaccine. | up to 7 months |
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |