MedDataX Logo

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

NCT ID: NCT01933412

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Hepatitis B

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dialysis Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sci-B-Vac Hepatitis B Vaccine

Sci-B-Vac Hepatitis B Vaccine

Group Type EXPERIMENTAL

Sci-B-Vac Hepatitis B Vaccine

Intervention Type BIOLOGICAL

Sci-B-Vac Hepatitis B Vaccine

Engerix B Hepatitis B Vaccine

Engerix B Hepatitis B Vaccine

Group Type ACTIVE_COMPARATOR

Engerix B Hepatitis B Vaccine

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sci-B-Vac Hepatitis B Vaccine

Sci-B-Vac Hepatitis B Vaccine

Intervention Type BIOLOGICAL

Engerix B Hepatitis B Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michal Roll PhD,MBA

Director of Institutional Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Talia Weinstein, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tel Aviv Sourasky Medical Center Dialysis Unit

Tel Aviv, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TLVMC1.2013

Identifier Type: -

Identifier Source: org_study_id