Efficacy and Safety of Hepatitis B Vaccine in Chronic Kidney Disease Patients

Study Overview
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Brief Summary
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This is an open label clinical study designed to evaluate the safety and immunogenicity of Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients. The study hypothesis is that vaccination with Sci B Vac will achieve a higher seroprotection rate and a higher anti-Hepatitis B surface antibody serum titer level than vaccination with Engerix-B Dialysis patients will be categorized as naïve or previously vaccinated and each group will be randomized to treatment. Naïve patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 10 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. Previously vaccinated patients randomized to Sci-B-Vac Hepatitis B vaccine will receive vaccination in three doses, 20 μg each, at 0, 1, and 6 months, or Engerix-B Hepatitis B vaccine given in four doses, 40 μg each, at 0, 1, 2, and 6 months. All vaccines will be administered via intra-muscular injection to the deltoid muscle. The study will consist of three periods: a screening period of up to four weeks, a 24-week open-label treatment period, and a 24-week safety follow-up period. The total expected duration of the study per subject is 52 weeks as follows: Screening period: approximately 4 weeks; treatment period: 24 weeks; and follow up period: 24 weeks. The primary endpoint is the by-vaccine difference in the proportion of subjects attaining seroprotective immune response (anti-Hepatitis B surface antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with either Sci-B-Vac or Engerix-B. Secondary endpoints include anti-Hepatitis B surface antibody geometric mean concentrations calculated for all subjects upon last active dose; the proportion of subjects with anti-Hepatitis B surface antibody concentrations equal to or above 10 IU/mL for all subjects at 12 weeks following the first vaccine dose; the by-treatment difference in serum titer levels of anti-Hepatitis B surface antibodies at 12, 24 and 52 weeks following the first vaccination. A by-vaccine comparison of adverse events will also be performed.

Official Title
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Efficacy and Safety of Sci B Vac vs. Engerix in Dialysis Patients

Conditions
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Chronic Kidney Disease, Hepatitis B

Intervention / Treatment
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* Biological: Sci-B-Vac Hepatitis B Vaccine
* Biological: Engerix B Hepatitis B Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Three months dialysis treatment for Chronic Kidney Disease; anti-Hepatitis B surface antibody titer levels < 10 IU/ml Exclusion Criteria: anti-Hepatitis B surface antibody titer levels > 10 IU/ml Hepatitis B surface antigen positive

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sci-B-Vac Hepatitis B Vaccine<br>Sci-B-Vac Hepatitis B Vaccine | Biological: Sci-B-Vac Hepatitis B Vaccine<br>* Sci-B-Vac Hepatitis B Vaccine<br>|
| Active Comparator: Engerix B Hepatitis B Vaccine<br>Engerix B Hepatitis B Vaccine | Biological: Engerix B Hepatitis B Vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-Hepatitis B surface levels ≥ 10 IU/mL | The by-vaccine difference in the proportion of subjects attaining seroprotective immune response (anti-Hepatitis B surface antibody ≥ 10 IU/mL) 4 weeks after the last vaccination with either Sci-B-Vac or Engerix-B. | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-Hepatitis B surface antibody Geometric Mean Concentrations | By vaccine comparison of anti-Hepatitis B surface antibody Geometric Mean Concentrations calculated for all subjects upon last active dose | 24 weeks | 
| 52 week anti-Hepatitis B surface antibody Geometric Mean Concentrations | By-vaccine comparison of anti-Hepatitis B surface antibody Geometric Mean Concentrations calculated for all subjects at week 52 | 52 weeks | 
| serum titer levels of anti-Hepatitis B surface antibodies | The by-treatment difference in serum titer levels of anti-Hepatitis B surface antibodies at 12, 24 and 52 weeks following the first vaccination. | 12, 24 and 52 weeks | 
| Adverse events | Spontaneous and elicited reports of all adverse events in all body systems. | 12, 24 and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Hepatitis B