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

Phase 3

• Conditions: Chronic Kidney Disease; Hepatitis B
• Interventions: Biological: Sci-B-Vac Hepatitis B Vaccine; Biological: Engerix B Hepatitis B Vaccine

• Registration Number: NCT01933412
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study First Submitted: 2013-08-28
• Study First Submitted QC: 2013-08-30
• Last Update Submitted: 2013-08-30
• Study First Posted: 2013-09-02
• Last Update Posted: 2013-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sci-B-Vac Hepatitis B Vaccine	Sci-B-Vac Hepatitis B Vaccine	Sci-B-Vac Hepatitis B Vaccine
Engerix B Hepatitis B Vaccine	Engerix B Hepatitis B Vaccine	Engerix B Hepatitis B Vaccine

Primary Outcome Measures

Name	Time	Method
anti-Hepatitis B surface levels ≥ 10 IU/mL	28 weeks	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 Outcome Measures

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

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center Dialysis Unit; 🇮🇱 Tel Aviv, Israel