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

NCT ID: NCT04531098

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-02
• Study Completion Date: 2008-12-31

Brief 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

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Sci-B-Vac-Lot B

Intervention Type: BIOLOGICAL

Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml

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.

Group Type: ACTIVE_COMPARATOR

Engerix-B

Intervention Type: BIOLOGICAL

Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection

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

Group Type: EXPERIMENTAL

Sci-B-Vac-Lot A

Intervention Type: BIOLOGICAL

Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml

Interventions

Sci-B-Vac-Lot B

Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml

Intervention Type: BIOLOGICAL

Sci-B-Vac-Lot A

Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml

Intervention Type: BIOLOGICAL

Engerix-B

Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection

Intervention Type: BIOLOGICAL

Other Intervention Names

Sci-B-Vac; 3-antigen HepB Vaccine; Bio-Hep-B; Sci-B-Vac; 3-antigen HepB Vaccine; Bio-Hep-B

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VBI Vaccines Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Do G Canh, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

National Institute of Hygiene and Epidemiology (NIHE)

Hanoi, , Vietnam

Countries

Vietnam

References

Diaz-Mitoma F, Popovic V, Spaans JN. Assessment of immunogenicity and safety across two manufacturing lots of a 3-antigen hepatitis B vaccine, Sci-B-Vac(R), compared with Engerix-B(R) in healthy Asian adults: A phase 3 randomized clinical trial. Vaccine. 2021 Jun 29;39(29):3892-3899. doi: 10.1016/j.vaccine.2021.05.067. Epub 2021 Jun 8.

Reference Type: DERIVED

PMID: 34116873 (View on PubMed)

Other Identifiers

SG-005-05

Identifier Type: -

Identifier Source: org_study_id