A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
1 other identifier
interventional
402
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2008
CompletedFirst Submitted
Initial submission to the registry
August 25, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedResults Posted
Study results publicly available
June 24, 2022
CompletedJuly 26, 2022
July 1, 2022
2.8 years
August 25, 2020
December 6, 2021
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360.
Days 180, 210, and 360
Anti-HBs Geometric Mean Concentration (GMC)
Days 180, 210, and 360
Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360.
Days 180, 210 and 360
Study Arms (3)
Sci-B-Vac-SciGen
EXPERIMENTALThe 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
Engerix-B
ACTIVE COMPARATORThe single antigen HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein. Engerix-B was supplied in 1.0 ml vials.
Sci-B-Vac-BTG
EXPERIMENTALThe 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
Interventions
Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml
Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml
Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Evidence of alcoholism or drug abuse, history of HIV, or HCV
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Hygiene and Epidemiology (NIHE)
Hanoi, Vietnam
Related Publications (1)
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.
PMID: 34116873DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Francisco Diaz-Mitoma
- Organization
- VBI Vaccines
Study Officials
- PRINCIPAL INVESTIGATOR
Do G Canh, MD
National Institute of Hygiene and Epidemiology (NIHE), Hanoi, Vietnam
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2020
First Posted
August 28, 2020
Study Start
March 2, 2006
Primary Completion
December 31, 2008
Study Completion
December 31, 2008
Last Updated
July 26, 2022
Results First Posted
June 24, 2022
Record last verified: 2022-07