Clinical trial NCT01933412: Efficacy and Safety of Hepatitis B Vaccine in Chronic Kidney Disease Patients
Official title: Efficacy and Safety of Sci B Vac vs. Engerix in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Kidney Disease
Hepatitis B
Keywords: Dialysis
Hepatitis B
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: anti-Hepatitis B surface levels ≥ 10 IU/mL
timeFrame: 28 weeks
Secondary outcomes:
measure: anti-Hepatitis B surface antibody Geometric Mean Concentrations
timeFrame: 24 weeks
measure: 52 week anti-Hepatitis B surface antibody Geometric Mean Concentrations
timeFrame: 52 weeks
measure: serum titer levels of anti-Hepatitis B surface antibodies
timeFrame: 12, 24 and 52 weeks
measure: Adverse events
timeFrame: 12, 24 and 52 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Dialysis Unit
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Talia Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: