A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults

July 18, 2022 updated by: VBI Vaccines Inc.

A Bridging Study: Comparing Two Sci-B-Vac™ Batches in Healthy Adults

This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response. Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam. Following a screening period, healthy eligible subjects (n = 402) were enrolled and randomized to receive Sci-B-Vac (OLD facility (Lot A) and NEW facility (Lot B), or Engerix-B.

The study was conducted in two stages, approximately a year-and-a-half apart. In the first stage (Stage I) beginning in March 2006, Sci-B-Vac (Lot A) vaccine was compared to Engerix-B; and in the second stage (Stage II) beginning in November 2007, the Sci-B-Vac (Lot B) vaccine was compared to Engerix-B. The subjects assigned to the Engerix-B group were equally divided between the stages, 67 subjects in the Engerix-B group in Stages I and II, respectively, for a total of 134 subjects, such that the final number of randomized subjects in Stage 1 and Stage 2 across the Sci-B-Vac Lot A, Sci-B-Vac Lot B and Engerix-B was 1:1:1, respectively. Immunogenicity evaluations for Stage I data (Visits 5 and 6) were conducted together with Stage II data.

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • National Institute of Hygiene and Epidemiology (NIHE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy adults 18 to 45 years of age who were seronegative for HBsAg, anti-HBs, anti-Hepatitis B core antigen, HIV, and Hepatitis C Virus (HCV)

Exclusion Criteria:

  • Evidence of alcoholism or drug abuse, history of HIV, or HCV
  • Blood transfusions within the three months prior to inclusion in the study
  • Uncontrolled hypertension and other cardiovascular diseases
  • Chronic/concurrent administration (>14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids were permitted
  • History of anaphylaxis (including shock) or any significant allergy or atopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sci-B-Vac-SciGen
The 3-antigen HepB vaccine, Sci-B-Vac-SciGen (SciGen Israel Ltd., produced in a new production facility located in Rehovot, Israel) contains three recombinant proteins of hepatitis B virus (HBV) envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac-SciGen was supplied in a final volume of 1.2 ml vials
Biological: Sci-B-Vac-Lot B
Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml
Other Names:
  • Sci-B-Vac
  • 3-antigen HepB Vaccine
  • Bio-Hep-B
Active Comparator: Engerix-B
The single antigen HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein. Engerix-B was supplied in 1.0 ml vials.
Biological: Engerix-B
Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection
Experimental: Sci-B-Vac-BTG
The 3-antigen HepB vaccine, Sci-B-Vac-BTG (Bio-Technology General (BTG) Ltd., Rehovot, Israel.) contains three recombinant proteins of HBV viral envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac-BTG was supplied in a final volume of 1.2 ml vials
Biological: Sci-B-Vac-Lot A
Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml
Other Names:
  • Sci-B-Vac
  • 3-antigen HepB Vaccine
  • Bio-Hep-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination
Time Frame: Day 210
Percentage of participants with an antibody response to hepatitis B surface antigens (anti-HBs), defined as an anti-HBs titer ≥10 IU/liter, one month after the third vaccination (Day 210) in the According-to-Protocol (ATP) population.
Day 210

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360.
Time Frame: Days 180, 210, and 360
Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥10 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population.
Days 180, 210, and 360
Anti-HBs Geometric Mean Concentration (GMC)
Time Frame: Days 180, 210, and 360
Geometric mean concentration (GMC) of anti-HBs antibody just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population.
Days 180, 210, and 360
Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360.
Time Frame: Days 180, 210 and 360
Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥100 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population.
Days 180, 210 and 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VBI Vaccines Inc.

Investigators

  • Principal Investigator: Do G Canh, MD, National Institute of Hygiene and Epidemiology (NIHE), Hanoi, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2006

Primary Completion (Actual)

December 31, 2008

Study Completion (Actual)

December 31, 2008

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG-005-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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