Overview

This trial is active, not recruiting.

Conditions chronic kidney disease, hepatitis b
Treatments sci-b-vac hepatitis b vaccine, engerix b hepatitis b vaccine
Phase phase 3
Sponsor Tel-Aviv Sourasky Medical Center
Start date March 2012
End date August 2013
Trial size 100 participants
Trial identifier NCT01933412, TLVMC1.2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Sci-B-Vac Hepatitis B Vaccine
sci-b-vac hepatitis b vaccine
Sci-B-Vac Hepatitis B Vaccine
(Active Comparator)
Engerix B Hepatitis B Vaccine
engerix b hepatitis b vaccine

Primary Outcomes

Measure
anti-Hepatitis B surface levels ≥ 10 IU/mL
time frame: 28 weeks

Secondary Outcomes

Measure
anti-Hepatitis B surface antibody Geometric Mean Concentrations
time frame: 24 weeks
52 week anti-Hepatitis B surface antibody Geometric Mean Concentrations
time frame: 52 weeks
serum titer levels of anti-Hepatitis B surface antibodies
time frame: 12, 24 and 52 weeks
Adverse events
time frame: 12, 24 and 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Efficacy and Safety of Sci B Vac vs. Engerix in Dialysis Patients
Principal investigator Talia Weinstein, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center.