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

Last updated: July 18, 2022
Sponsor: VBI Vaccines Inc.
Overall Status: Completed

Phase

3

Condition

Hepatitis

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT04531098
SG-005-05
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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 otherimmune-modifying drugs within six months prior to the first vaccine dose. Inhaled andtopical steroids were permitted
  • History of anaphylaxis (including shock) or any significant allergy or atopy

Study Design

Total Participants: 402
Study Start date:
March 02, 2006
Estimated Completion Date:
December 31, 2008

Study 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.

Connect with a study center

  • National Institute of Hygiene and Epidemiology (NIHE)

    Hanoi,
    Vietnam

    Site Not Available

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