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| Name | Class |
|---|---|
| Xiamen Innovax Biotech Co., Ltd | INDUSTRY |
| Xiamen Center for Disease Control and Prevention | UNKNOWN |
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The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senior group(over 65 years old)-HE | Experimental | Anti-HEV IgG seronegative participants over 65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
|
| Younger groups(16-65 years old) | Active Comparator | Participants aged 16-65 years old were enrolled. Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses. |
|
| Senior group(over 65 years old)-Cont | No Intervention | Anti-HEV IgG seropositive participants over 65 years old were enrolled. This is the safety control group, without any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant (E. Coli) Hepatitis E Vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded. | From month 0-7 |
| Measure | Description | Time Frame |
|---|---|---|
| anti-HEV IgG seropositive rate | at month 7 | |
| GMT of anti-HEV IgG | Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested | 7 month after first vaccination |
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Inclusion Criteria:
Exclusion Criteria:
For dose 1:
For dose 2 or 3:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for disease control and prevention in Xiamen haicang district | Xiamen | Fujian | 361000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20728932 | Background | Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20. |
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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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| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |