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Trial record 2 of 2 for:    SG005

Lot-to-Lot Consistency of Two Batches of Sci-B-Vac and Comparison to Engerix-B

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ClinicalTrials.gov Identifier: NCT04531098
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
VBI Vaccines Inc.

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

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Sci-B-Vac-SciGen Biological: Sci-B-Vac-BTG Biological: Engerix-B Phase 3

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 in a 1:1:1 ratio to receive Sci-B-Vac OLD BTG, or Sci-B-Vac NEW SciGen, 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 (OLD BTG) vaccine was compared to Engerix-B; and in the second stage (Stage II) beginning in November 2007, the Sci-B-Vac (NEW SciGen) 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. Immunogenicity evaluations for Stage I data (Visits 5 and 6) were conducted together with Stage II data.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single blind, three-arm, two-stage, randomized study
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Bridging Study: Comparing Two Sci-B-Vac Batches in Healthy Adults
Actual Study Start Date : March 2, 2006
Actual Primary Completion Date : December 31, 2008
Actual Study Completion Date : December 31, 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sci-B-Vac-SciGen
The tri-antigenic 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-SciGen
Sci-B-Vac vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml
Other Names:
  • Sci-B-Vac
  • Tri-Antigenic Vaccine
  • Bio-Hep-B

Active Comparator: Engerix-B
The mono-antigenic 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 tri-antigenic HepB vaccine, Sci-B-Vac-OLD 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-OLD BTG was supplied in a final volume of 1.2 ml vials
Biological: Sci-B-Vac-BTG
Sci-B-Vac OLD BTG - 10 μg of HBsAg, intramuscular injection of 10 μg/ml
Other Names:
  • Sci-B-Vac
  • Tri-Antigenic Vaccine
  • Bio-Hep-B




Primary Outcome Measures :
  1. The antibody response to hepatitis B surface antigens (anti-HBs [ Time Frame: Day 180 ]
    Demonstrate clinical equivalence of Sci-B-Vac BTG and Sci-B-Vac SciGen as measured by the antibody response to hepatitis B surface antigens (anti-HBs). Immunogenicity was defined as anti-HBs titer ≥10 IU/liter one month after the third vaccination (Day 210)


Secondary Outcome Measures :
  1. Percentage of patients with anti-HBs titer ≥10 IU/liter just prior (Day 180) and six months (Day 360) after the third vaccination [ Time Frame: day 180 and six months after the third vaccination ]
    Anti-HBs immune response

  2. Anti-HBs geometric mean concentration (GMC) for each blood sample taken [ Time Frame: baseline and six months after the third vaccination ]
    Anti-HBs immune response

  3. Seroprotection rate at the level of 100 IU/liter just prior to the third vaccination (Day 180), at one month (Day 210), and 6 months after the third vaccination (Day 360) [ Time Frame: prior to the third vaccination (Day 180), at one month (Day 210), and 6 months after the third vaccination (Day 360) ]
    Anti-HBs immune response

  4. Anti-HBs titer concentrations for study day 1 through Day 360 [ Time Frame: day 1 through Day 360 ]
    Anti-HBs immune response

  5. The percentage of subjects with local and systemic adverse events (AEs) [ Time Frame: Day 210 and Day 360 ]

    Evaluate the safety of Sci-B-Vac BTG, Sci-B-Vac SciGen and Engerix-B as percentage of subjects with local and systemic adverse events (AEs) after each vaccination with Sci-B-Vac BTG, Sci-B-Vac SciGen or Engerix-B

    Data were collected at patient visits and on patient diary cards for five consecutive days following each vaccination




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531098


Locations
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Vietnam
National Institute of Hygiene and Epidemiology (NIHE)
Hanoi, Vietnam
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
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Principal Investigator: Do G Canh, MD National Institute of Hygiene and Epidemiology (NIHE), Hanoi, Vietnam
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Responsible Party: VBI Vaccines Inc.
ClinicalTrials.gov Identifier: NCT04531098    
Other Study ID Numbers: SG-005-05
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VBI Vaccines Inc.:
Sci-B-Vac
Prophylactic vaccine
Hepatitis B vaccines
Phase 3
pre-S1
pre-S2
Surface antigen
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs