Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04179786
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2019-10-07
Brief Title:
A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac
Sponsor:
VBI Vaccines Inc
Organization:
VBI Vaccines Inc
Study Overview
Official Title:
An Open-label Single Arm Single Center Clinical Study In Healthy Subjects to Qualify an In-house Reference Standard Batch of Sci-B-Vac
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Each Sci-B-Vac lot to be released to the market is tested in comparison to a reference batchwhich 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 PhEur 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
Detailed Description:
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 inclusionexclusion 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 inclusionexclusion 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 mIUml by month 7 ie 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 950 exact confidence interval CI was 860 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 populationFor 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
Statistical Methods A total of 92 subjects were recruited into the study Subjects who fully complied with the study protocol had no inclusionexclusion 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 inclusionexclusion 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 mIUml by month 7 ie 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 950 exact confidence interval CI was 860 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 populationFor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None