Trial Outcomes & Findings for A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™ (NCT NCT04179786)
NCT ID: NCT04179786
Last Updated: 2022-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
91 participants
Primary outcome timeframe
Month 7 (i.e. one month after the third immunization with Sci-B-Vac™)
Results posted on
2022-06-24
Participant Flow
Participant milestones
| Measure |
Sci-B-Vac™
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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|---|---|
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Overall Study
STARTED
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91
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Overall Study
COMPLETED
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83
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Sci-B-Vac™
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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|---|---|
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Overall Study
Withdrawal by Subject
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8
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Baseline Characteristics
A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™
Baseline characteristics by cohort
| Measure |
Sci-B-Vac™
n=91 Participants
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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|---|---|
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Age, Continuous
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26.24 years
STANDARD_DEVIATION 4.79 • n=5 Participants
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Age, Customized
Between 20 and 30 years
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75 Participants
n=5 Participants
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Age, Customized
Between 31 and 40 years
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16 Participants
n=5 Participants
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Sex: Female, Male
Female
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17 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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74 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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91 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Israel
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91 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Month 7 (i.e. 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.
Outcome measures
| Measure |
Sci-B-Vac™
n=83 Participants
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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Seroprotection Rate Achieved One Month After the Third Immunization With Sci-B-Vac™.
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83 Participants
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SECONDARY outcome
Timeframe: At one month after the first injection, and then at every month until month 7 inclusive and at months 9 and 12.Population: The immunogenicity results presented here were obtained through analyses performed on the modified intent-to-treat (ITT) analysis set. This set consisted of all enrolled subjects who were vaccinated at least once with Sci-B-Vac™ at least one post vaccination follow-up visit, fully comply with the study protocol, had no violation of any of the inclusion/exclusion criteria and did not demonstrate an anamnestic response after the 1st administration of Sci-B-Vac™.
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.
Outcome measures
| Measure |
Sci-B-Vac™
n=88 Participants
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 1
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50 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 2
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79 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 3
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85 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 4
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83 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 5
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82 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 6
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82 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 7
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83 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 9
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83 Participants
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Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up
Month 12
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84 Participants
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SECONDARY outcome
Timeframe: At one month after the first injection, and then at every month until month 7 inclusive and at months 9 and 12.Population: The immunogenicity results presented here were obtained through analyses performed on the modified intent-to-treat (ITT) analysis set. This set consisted of all enrolled subjects who were vaccinated at least once with Sci-B-Vac™ at least one post vaccination follow-up visit, fully comply with the study protocol, had no violation of any of the inclusion/exclusion criteria and did not demonstrate an anamnestic response after the 1st administration of Sci-B-Vac™.
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.
Outcome measures
| Measure |
Sci-B-Vac™
n=88 Participants
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 1
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32 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 2
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66 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 3
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70 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 4
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71 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 5
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70 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 6
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70 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 7
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81 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 9
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80 Participants
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Percentage of Subjects With HBs Antibody Titer ≥100 mIU/ml at Each Timepoint
Month 12
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77 Participants
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SECONDARY outcome
Timeframe: At one month after the first injection, and then at every month until month 7 inclusive and at months 9 and 12.Population: The immunogenicity results presented here were obtained through analyses performed on the modified intent-to-treat (ITT) analysis set. This set consisted of all enrolled subjects who were vaccinated at least once with Sci-B-Vac™ at least one post vaccination follow-up visit, fully comply with the study protocol, had no violation of any of the inclusion/exclusion criteria and did not demonstrate an anamnestic response after the 1st administration of Sci-B-Vac™.
The Cobas™ e601 anti-HBs assay was used to assess the HBs antibody titer.
Outcome measures
| Measure |
Sci-B-Vac™
n=88 Participants
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 1
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1.49 mIU/ml
Interval 0.36 to 6.12
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 2
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358.62 mIU/ml
Interval 201.03 to 639.75
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 3
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413.59 mIU/ml
Interval 249.11 to 686.68
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 4
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379.06 mIU/ml
Interval 234.43 to 612.93
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 5
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343.89 mIU/ml
Interval 213.79 to 553.16
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 6
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300.30 mIU/ml
Interval 187.94 to 479.85
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 7
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6799.87 mIU/ml
Interval 4216.64 to 10965.66
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 12
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2281.08 mIU/ml
Interval 1426.95 to 3646.49
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Geometric Mean Concentration (GMC) as Determined by HBs Antibody Titers
Month 9
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4170.86 mIU/ml
Interval 2610.57 to 6663.71
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Adverse Events
Sci-B-Vac™
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sci-B-Vac™
n=91 participants at risk
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.
Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices. 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.
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Nervous system disorders
Headache
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37.4%
34/91 • Number of events 65 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Gastrointestinal disorders
Oropharyngeal pain
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30.8%
28/91 • Number of events 39 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Infections and infestations
Rhinitis
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29.7%
27/91 • Number of events 32 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Respiratory, thoracic and mediastinal disorders
Cough
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18.7%
17/91 • Number of events 18 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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General disorders
Pyrexia
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16.5%
15/91 • Number of events 18 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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General disorders
Asthenia
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13.2%
12/91 • Number of events 13 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Gastrointestinal disorders
Diarrhea
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11.0%
10/91 • Number of events 11 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Gastrointestinal disorders
Toothache
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8.8%
8/91 • Number of events 9 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Musculoskeletal and connective tissue disorders
Back pain
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7.7%
7/91 • Number of events 8 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Gastrointestinal disorders
Abdominal pain upper
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6.6%
6/91 • Number of events 7 • 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.
AEs were recorded continuously starting from the signing of the ICF through the Study Termination visit, in those subjects who have been actually dosed.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place