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

August 30, 2013 updated by: Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center Dialysis Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sci-B-Vac Hepatitis B Vaccine
Biological: Sci-B-Vac Hepatitis B Vaccine
Sci-B-Vac Hepatitis B Vaccine
Active Comparator: Engerix B Hepatitis B Vaccine
Biological: Engerix B Hepatitis B Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti-Hepatitis B surface levels ≥ 10 IU/mL
Time Frame: 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.
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anti-Hepatitis B surface antibody Geometric Mean Concentrations
Time Frame: 24 weeks
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
Time Frame: 52 weeks
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
Time Frame: 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.
12, 24 and 52 weeks
Adverse events
Time Frame: 12, 24 and 52 weeks
Spontaneous and elicited reports of all adverse events in all body systems.
12, 24 and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Talia Weinstein, MD, Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimate)

September 2, 2013

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLVMC1.2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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