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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01933412
Recruitment Status : Unknown
Verified August 2013 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2013
Last Update Posted : September 2, 2013
Sponsor:
Information provided by (Responsible Party):
Michal Roll PhD,MBA, 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hepatitis B Biological: Sci-B-Vac Hepatitis B Vaccine Biological: Engerix B Hepatitis B Vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Sci B Vac vs. Engerix in Dialysis Patients
Study Start Date : March 2012
Estimated Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sci-B-Vac Hepatitis B Vaccine
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
Engerix B Hepatitis B Vaccine
Biological: Engerix B Hepatitis B Vaccine



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. Adverse events [ Time Frame: 12, 24 and 52 weeks ]
    Spontaneous and elicited reports of all adverse events in all body systems.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933412


Locations
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Israel
Tel Aviv Sourasky Medical Center Dialysis Unit
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Talia Weinstein, MD Tel-Aviv Sourasky Medical Center

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Responsible Party: Michal Roll PhD,MBA, Director of Institutional Research, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01933412    
Other Study ID Numbers: TLVMC1.2013
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013
Keywords provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:
Dialysis
Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Kidney Diseases
Renal Insufficiency, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Urologic Diseases
Renal Insufficiency
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs