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The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.
Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted Hepatitis B vaccine Lot 1 | Biological | 20 µg, IM, month 0 and 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs seroprotection rates at Month 2. | Month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HBs geometric mean concentration, seropositivity rates, seroprotection rates and the percentage of subjects with antibody concentrations superior or equal to 100 mIU/ml after HB-AS02V vaccination, at all time points. | Month 0, 1 and 2 | |
| Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms, within 4 days after administration of study vaccine (Day 0 to 3). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiri Beran, MD | Vaccination and Travel Medicine Centre Poliklinika II | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccination and Travel Medicine Centre Poliklinika II | Hradec Králové | 500 03 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20523113 | Derived | Beran J, Hobzova L, Wertzova V, Kuriyakose S, Leyssen M, Surquin M, Houard S. Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. Hum Vaccin. 2010 Jul;6(7):578-84. doi: 10.4161/hv.6.7.11883. Epub 2010 Jul 1. |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Adjuvanted Hepatitis B vaccine Lot 2 |
| Biological |
20µg, IM, month 0 and 1 |
|
| Adjuvanted Hep B vaccine Lot 3 | Biological | 20µg, IM, month 0 and 1 |
|
| Month 0 and 1 |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30) | Month 0 and 1 |
| Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2. | Month 0 to 2 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |