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

T

Tel Aviv Sourasky Medical Center

Status and phase

Unknown
Phase 3

Conditions

Chronic Kidney Disease
Hepatitis B

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01933412
TLVMC1.2013

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Sci-B-Vac Hepatitis B Vaccine
Experimental group
Description:
Sci-B-Vac Hepatitis B Vaccine
Treatment:
Biological: Sci-B-Vac Hepatitis B Vaccine
Engerix B Hepatitis B Vaccine
Active Comparator group
Description:
Engerix B Hepatitis B Vaccine
Treatment:
Biological: Engerix B Hepatitis B Vaccine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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