Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase III, Single Centre, Double Blind, Randomised Study Evaluating the Consistency of Three Lots of Henogen's New Adjuvanted Hepatitis B Vaccine, When Given at 0, 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years.

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Adjuvanted Hepatitis B vaccine Lot 1
* Biological: Adjuvanted Hepatitis B vaccine Lot 2
* Biological: Adjuvanted Hep B vaccine Lot 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy male or female adult aged between 18 and 40 years. Written informed consent obtained from the subject Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose. Concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device). History of hepatitis B infection. Known exposure to hepatitis B virus within 6 months. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Biological: Adjuvanted Hepatitis B vaccine Lot 1<br>* 20 µg, IM, month 0 and 1<br>|
| Active Comparator: 2<br> | Biological: Adjuvanted Hepatitis B vaccine Lot 2<br>* 20µg, IM, month 0 and 1<br>|
| Active Comparator: 3<br> | Biological: Adjuvanted Hep B vaccine Lot 3<br>* 20µg, IM, month 0 and 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs seroprotection rates at Month 2. |  | Month 2 | 

Secondary Outcome Measures

| Outcome Measure | 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). |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Consistency, Immunogenicity