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To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.
By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20μg Engerix-B with 0-1-6 intervals | Experimental | Received three intramuscular injections of the 20μg Engerix-B vaccine with 0, 1, 6 month intervals |
|
| 20μg Kangtai with 0-1-6 intervals | Experimental | Received three intramuscular injections of the 20μg Kangtai hepatitis B vaccine with 0, 1, 6 month intervals |
|
| 60μg Kangtai with 0-2 intervals | Experimental | Received two intramuscular injections of the 60μg Kangtai hepatitis B vaccine with 0, 2 month intervals |
|
| 20μg CHO with 0-1-6 intervals | Placebo Comparator | Received three intramuscular injections of the 20μg Huabei hepatitis B vaccine made by recombinant DNA techniques in CHO cell with 0, 1, 6 month intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20μg Engerix-B hepatitis B vaccine | Biological |
| ||
| 20μg Kangtai hepatitis B vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs | Titers of hepatitis B virus surface antibody | at the second month after the final injection of each arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhang | Beijing Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huaibei District Center for Disease Control and Prevention | Huaibei | Anhui | 235000 | China | ||
| Xuanhua District Center for Disease Control and Prevention |
The original primary outcome data will be shared
the data will become available after publication permanent
With consent of the principal investigator
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| Biological |
|
| 60μg Kangtai hepatitis B vaccine | Biological |
|
| 20μg CHO | Biological |
|
| Xuanhua |
| Hebei |
| 075199 |
| China |