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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531098
• Other study ID #: SG-005-05
• Status: Completed
• Phase: Phase 3
• Start date: March 2, 2006
• Est. completion date: December 31, 2008

Study information

• Verified date: July 2022
• Source: VBI Vaccines Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 31, 2008
• Est. primary completion date: December 31, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• Sci-B-Vac-Lot B
Sci-B-Vac Lot B -10 µg of HBsAg, intramuscular injection of 10 µg/ml
• Sci-B-Vac-Lot A
Sci-B-Vac Lot A - 10 µg of HBsAg, intramuscular injection of 10 µg/ml
• Engerix-B
Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection

Locations

Country	Name	City	State
Vietnam	National Institute of Hygiene and Epidemiology (NIHE)	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
VBI Vaccines Inc.

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Antibody Response (=10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination	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	Percentage of Participants With an Anti-HBs Antibody Titer =10 IU/Liter at 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
Secondary	Anti-HBs Geometric Mean Concentration (GMC)	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
Secondary	Percentage of Participants With an Anti-HBs Antibody Titer =100 IU/Liter at 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