A Phase 4 interventional study of Sci-B-Vac™ in Hepatitis B, sponsored by VBI Vaccines Inc.. Completed. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-24.
Sponsored by VBI Vaccines Inc. · Phase 4, Interventional, and Prevention
Each Sci-B-Vac™ lot to be released to the market is tested in comparison to a reference batch,which has to be tested in a human clinical trial. This study was conducted by SciVac Ltd. to to evaluate the immunogenicity and explore the immune kinetics of Sci-B-Vac™ in support of its qualification as new reference standard which according to the European Pharmacopeia (Ph.Eur. 1056) should elicit ≥ 95% seroprotection rate (SPR) of Hepatitis B surface (HBs) antibody concentrations ≥ 10 milli-International Units (mIU) per ml in young, healthy adult subjects.
This study was a post-marketing, open-label, single arm study in healthy volunteers who had never been vaccinated with any hepatitis B vaccine and were seronegative to HBsAg, Hepatitis B core (HBc) and HBs antibodies. This study consisted of three periods: screening period (up to 1 month prior to first vaccination), treatment (Day 1 to month 6), and post-vaccination follow-up period (months 6 -12). Immunogenicity endpoints were examined one month after the first injection and at every month until month 6, then at months 7, 9 and 12. The primary safety endpoint was the frequency, severity, and duration of adverse events, including clinically-significant laboratory abnormalities after administration of Sci-B-Vac™.
Statistical Methods: A total of 92 subjects were recruited into the study. Subjects who fully complied with the study protocol, had no inclusion/exclusion criteria violation and who early terminated the study but reached the primary endpoint prior to withdrawal (modified intention-to-treat (mITT) population) were included in the final population for statistical analysis. mITT population was defined as the subset of the ITT set, which consisted of all enrolled subjects who were vaccinated at least once with Sci-B-Vac™ and had at least one post-vaccination follow-up visit, fully complied with the protocol and had no violation of the inclusion/exclusion criteria. Eligible subjects were followed for a total duration of 12 months.
Significance Level: The overall significance level for this study was 5% using two-tailed tests. Sample size determination was performed under the following assumptions:
The primary endpoint for the study was the SPR, defined as the proportion of subjects with HBs antibody titer ≥10 mIU/ml by month 7 (i.e. one month after the third immunization with Sci-B-Vac™). Subjects terminated early from the study for any reason at any time and who met the primary endpoint were included.
In compliance with the European Pharmacopeia, the SPR threshold was set at ≥ 95%. Based on a 9% margin of non-inferiority, the study was considered successful if the lower bound of the 95.0% exact confidence interval (CI) was 86.0% or more (lower non-inferiority limit) by month 7.
The secondary objective of the study was to explore kinetics of immune response induced by Sci-B-Vac™ based on serial immunogenicity measurements.
Demographic and baseline data as well as disease prognostic factors, medical history and prior medications were summarized for the mITT population,For continuous variables, descriptive statistics (number [n], mean, standard deviation (SD), standard error, median, minimum, and maximum) were provided. For categorical variables, subject counts and percentages were provided.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 91 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →VBI Vaccines Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study in healthy volunteers who had never been vaccinated with any hepatitis B vaccine and who were seronegative for antibodies to HBsAg, HBc and HBs at baseline.
Biological: Sci-B-Vac™
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices (GMP). It contains the 3 surface antigens of the Hepatitis B virus: HBs, pre-S1 and pre-S2. Each 1 ml dose contains sterile 10 μg Hepatitis B virus surface antigens. It is formulated for intramuscular injection supplied in single use vials containing 1ml suspension.
Seroprotection Rate Achieved One Month After the Third Immunization With Sci-B-Vac™.
SPR (% of subjects ≥ 10 mIU/mL) one month after immunization with Sci-B-Vac™ at months 0, 1 and 6 was calculated by measuring the HBs antibody titers using Cobas™ e601 anti-HBs assay. Subjects who received at least one Sci-B-Vac™ dose and early terminated from the study for any reason at any time while having HBs antibody concentrations ≥ 10 mIU/ml were considered among those who met the endpoint.
Time frame: Month 7 (i.e. one month after the third immunization with Sci-B-Vac™)
Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
The endpoint for the study was the SPR, defined as the percentage of subjects with HBs antibody titer ≥10 mIU/ml. The Cobas™ e601 anti-HBs assay was used to assess the HBs antibody titer.
Time frame: At one month after the first injection, and then at every month until month 7 inclusive and at months 9 and 12.
Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
The outcome was the proportion of subjects with HBs antibody titer ≥100 mIU/ml. The Cobas™ e601 anti-HBs assay was used to assess the HBs antibody titer.
Time frame: At one month after the first injection, and then at every month until month 7 inclusive and at months 9 and 12.
Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
The Cobas™ e601 anti-HBs assay was used to assess the HBs antibody titer.
Time frame: At one month after the first injection, and then at every month until month 7 inclusive and at months 9 and 12.
| Milestone | Sci-B-Vac™ |
|---|---|
| Started | 91 |
| Completed | 83 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 8 |
SPR (% of subjects ≥ 10 mIU/mL) one month after immunization with Sci-B-Vac™ at months 0, 1 and 6 was calculated by measuring the HBs antibody titers using Cobas™ e601 anti-HBs assay. Subjects who received at least one Sci-B-Vac™ dose and early terminated from the study for any reason at any time while having HBs antibody concentrations ≥ 10 mIU/ml were considered among those who met the endpoint.
| Participants | Sci-B-Vac™ |
|---|---|
| Seroprotection Rate Achieved One Month After the Third Immunization With Sci-B-Vac™. | 83 |
The endpoint for the study was the SPR, defined as the percentage of subjects with HBs antibody titer ≥10 mIU/ml. The Cobas™ e601 anti-HBs assay was used to assess the HBs antibody titer.
| Participants | Sci-B-Vac™ |
|---|---|
| Month 1 | 50 |
| Month 2 | 79 |
| Month 3 | 85 |
| Month 4 | 83 |
| Month 5 | 82 |
| Month 6 | 82 |
| Month 7 | 83 |
| Month 9 | 83 |
| Month 12 | 84 |
The outcome was the proportion of subjects with HBs antibody titer ≥100 mIU/ml. The Cobas™ e601 anti-HBs assay was used to assess the HBs antibody titer.
| Participants | Sci-B-Vac™ |
|---|---|
| Month 1 | 32 |
| Month 2 | 66 |
| Month 3 | 70 |
| Month 4 | 71 |
| Month 5 | 70 |
| Month 6 | 70 |
| Month 7 | 81 |
| Month 9 | 80 |
| Month 12 | 77 |
The Cobas™ e601 anti-HBs assay was used to assess the HBs antibody titer.
| mIU/ml | Sci-B-Vac™ |
|---|---|
| Month 1 | 1.49 (0.36 to 6.12) |
| Month 2 | 358.62 (201.03 to 639.75) |
| Month 3 | 413.59 (249.11 to 686.68) |
| Month 4 | 379.06 (234.43 to 612.93) |
| Month 5 | 343.89 (213.79 to 553.16) |
| Month 6 | 300.30 (187.94 to 479.85) |
| Month 7 | 6799.87 (4216.64 to 10965.66) |
| Month 9 | 4170.86 (2610.57 to 6663.71) |
| Month 12 | 2281.08 (1426.95 to 3646.49) |
Collected over AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who received at least one dose of Sci-B-Vac™, approximately 13 months.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sci-B-Vac™ | 0/91 (0%) | 0/91 (0%) | 76/91 (83.5%) |
| Event | Sci-B-Vac™ |
|---|---|
| HeadacheNervous system disorders | 34/91 |
| Oropharyngeal painGastrointestinal disorders | 28/91 |
| RhinitisInfections and infestations | 27/91 |
| CoughRespiratory, thoracic and mediastinal disorders | 17/91 |
| PyrexiaGeneral disorders | 15/91 |
| AstheniaGeneral disorders | 12/91 |
| DiarrheaGastrointestinal disorders | 10/91 |
| ToothacheGastrointestinal disorders | 8/91 |
| Back painMusculoskeletal and connective tissue disorders | 7/91 |
| Abdominal pain upperGastrointestinal disorders | 6/91 |
| Age, Continuous(years) | Sci-B-Vac™ |
|---|---|
| Mean | 26.24 ± 4.79 |
| Age, Customized(Participants) | Sci-B-Vac™ |
|---|---|
| Between 20 and 30 years | 75 |
| Between 31 and 40 years | 16 |
| Sex: Female, Male(Participants) | Sci-B-Vac™ |
|---|---|
| Female | 17 |
| Male | 74 |
| Race (NIH/OMB)(Participants) | Sci-B-Vac™ |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 91 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Sci-B-Vac™ |
|---|---|
| Israel | 91 |
No study locations are listed for this record.
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VBI Vaccines Inc.