Phase 3
Completed N=201
A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults
Source: ClinicalTrials.gov NCT04531098 ↗Enrolled (actual)
201
Serious AEs
2.0%
Results posted
Jun 2022
Primary outcomePrimary: Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination — 120; 115; 109 Participants
◆ Published Evidence
Emerging
12citations · ~2 / year
Assessment of immunogenicity and safety across two manufacturing lots of a 3-antigen hepatitis B vaccine, Sci-B-Vac®, compared with Engerix-B® in healthy Asian adults: A phase 3 randomized 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
Linked Publications
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Assessment of immunogenicity and safety across two manufacturing lots of a 3-antigen hepatitis B vaccine, Sci-B-Vac®, compared with Engerix-B® in healthy Asian adults: A phase 3 randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination |
120; 115; 109 | — |
| SECONDARY Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360. |
118; 95; 102; 120; 115; 109 | — |
| SECONDARY Anti-HBs Geometric Mean Concentration (GMC) |
328.64; 44.42; 147.30; 12,158.94; 4,124.24; 3,587.30 | — |
| SECONDARY Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360. |
99; 40; 68; 118; 113; 106 | — |
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
Data sourced from ClinicalTrials.gov (NCT04531098) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.