Phase 3
N=100
Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT04209400 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Seroconversion Rate — 47; 46 Participants — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sci-B-Vac® (Biological); Engerix-B® (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VBI Vaccines Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Rate |
0; 0; 46; 36; 48; 45 | — |
| SECONDARY Seroprotection Rate |
0; 0; 30; 24; 47; 41 | — |
| SECONDARY Seroconversion Rate |
0; 0; 46; 36; 48; 45 | — |
| SECONDARY Geometric Mean Concentrations (GMC) of HBs Antibodies |
618.3; 378.7; 757.7; 441.3; 891.4; 787.0 | — |
Summary
This study was a comparative, randomized, double-blind clinical study of the efficacy and safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel groups of hepatitis B-naive healthy adult subjects in Russia.
Eligibility Criteria
Inclusion Criteria
- Availability of written Informed Consent to participate in the study from the subject.
- Male or female between 18 and 45 years old without previous contact with hepatitis B virus (HBV).
- Good health condition based on full physical examination.
- Normal values of laboratory biochemical blood tests.
- Seronegative with respect to anti-HBs (surface) antibodies, anti-HBc (core) antibodies, and HBs Antigen (HBsAg) on screening.
- Not pregnant and not breast-feeding.
- For men and women of reproductive age: consent for use of an effective contraception method, for example, an intrauterine device, oral contraceptive, hypodermic implant or double barrier method (a condom with contraceptive sponge or contraceptive suppository) throughout the entire study.
Exclusion Criteria
- Congenital or inherited immunodeficiency disorder in family history.
- Information of a serious blood disorder, cardiac disorder, or tumour.
- Current use of any medication that could alter immune reactivity.
- Infection with HBV at the present time or in the past, confirmed by HBV markers test.
- Anaphylaxis or severe allergy, or atopy, history of alcoholism or drug abuse.
- Pregnancy and breast-feeding.
Data sourced from ClinicalTrials.gov (NCT04209400). 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.