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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01933412
• Other study ID #: TLVMC1.2013
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 28, 2013
• Last updated: August 30, 2013
• Start date: March 2012

Study information

• Verified date: August 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hepatitis
• Hepatitis A
• Hepatitis B
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• Sci-B-Vac Hepatitis B Vaccine
Sci-B-Vac Hepatitis B Vaccine
• Engerix B Hepatitis B Vaccine

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center Dialysis Unit	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-Hepatitis B surface levels = 10 IU/mL	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	No
Secondary	anti-Hepatitis B surface antibody Geometric Mean Concentrations	By vaccine comparison of anti-Hepatitis B surface antibody Geometric Mean Concentrations calculated for all subjects upon last active dose	24 weeks	No
Secondary	52 week anti-Hepatitis B surface antibody Geometric Mean Concentrations	By-vaccine comparison of anti-Hepatitis B surface antibody Geometric Mean Concentrations calculated for all subjects at week 52	52 weeks	No
Secondary	serum titer levels of anti-Hepatitis B surface antibodies	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	No
Secondary	Adverse events	Spontaneous and elicited reports of all adverse events in all body systems.	12, 24 and 52 weeks	Yes