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Clinical and Experimental Nephrology

, Volume 22, Issue 1, pp 151–158 | Cite as

A randomized, controlled clinical trial to evaluate the immunogenicity of a PreS/S hepatitis B vaccine Sci-B-Vac™, as compared to Engerix B®, among vaccine naïve and vaccine non-responder dialysis patients

  • E. Elhanan
  • M. Boaz
  • I. Schwartz
  • D. Schwartz
  • G. Chernin
  • H. Soetendorp
  • A Gal Oz
  • A. Agbaria
  • T. WeinsteinEmail author
Original article

Abstract

Background

Dialysis patients have a suboptimal response to hepatitis B (HBV) vaccination. This study aimed to compare the immunogenicity of two vaccines: the third-generation Sci-B-Vac™ vs. the second-generation Engerix B®. The cohort included two groups of dialysis patients: naïve and previously vaccinated non-responders. Primary endpoints were antibody titers ≥10 IU/L at 3 and 7 month post-vaccination. Secondary objectives were seroprotection rates in vaccine-naïve patients and in previously vaccinated non-responders.

Methods

Eighty-six patients were assigned to vaccine (Sci-B-Vac™ or Engerix B®) using computer-generated randomization, stratified by age, gender, diabetes, and previous HBV vaccination. Sci-B-Vac™ was administered in three doses, 10 μg, at 0, 1, and 6 months in naïve patients; or 20 μg in previously vaccinated non-responders. Engerix B® included four doses, 40 μg at 0, 1, 2, and 6 months.

Results

Each group had 43 patients. Seroconversion was 69.8% with Engerix B® vs. 73.2% with Sci-B-Vac™. Antibody titers at 7 months were higher with Sci-B-Vac™ (266.4 ± 383.9, median 53.4) than with Engerix® (193.2 ± 328.9, median 19). However, these differences were not significant, perhaps due to a suboptimal sample size.

Conclusions

This study suggests comparable immunogenicity for both vaccines. Thus, we cannot reject the null hypothesis that there is no difference in seroconversion by vaccine type. It is noteworthy that naïve patients were vaccinated with a standard dose of Sci-B-Vac™, while Engerix B® was administered at a double dose. Similarly, although mean antibody titer levels in the Sci-B-Vac™ group were higher than in the Engerix® group, this difference did not reach significance. Consequently, a future clinical trial should recruit a larger cohort of patients, using a standard double-dose protocol in both groups.

Keywords

Dialysis HBV vaccine Sci-B-Vac Engerix 

Notes

Compliance with ethical standards

Informed consent

All procedures performed in human participants were in accordance with the ethical standards of the Institutional Research Committee at Tel Aviv Medical Center (0423-11-TLV) and with the 1964 Helsinki declaration and its later amendments. All participants signed an informed consent.

Conflict of interest

MB and TW served as scientific advisors to SciVac Therapeutics Inc. for 1 year. This association was not in effect at the time of the study.

Funding

There was no funding.

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Copyright information

© Japanese Society of Nephrology 2017

Authors and Affiliations

  1. 1.Nephrology Department, Tel Aviv Sourasky Medical Center, Sackler Faculty of MedicineTel Aviv UniversityTel AvivIsrael
  2. 2.Epidemiology and Research Unit, E. Wolfson Medical CenterHolonIsrael
  3. 3.Ariel UniversityArielIsrael

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