CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 91 enrolled
Drug / intervention
Sci-B-Vac™biological
Likely dose
Sci-B-Vac™ 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04179786
NCT04179786Phase 4Completed
CompareCT.gov

An Open-label, Single Arm, Single Center Clinical Study In Healthy Subjects to Qualify an In-house Reference Standard Batch of Sci-B-Vac™

VBI Vaccines Inc.·interventional·Posted Nov 27, 2019·Updated Jun 24, 2022

In Brief

A Phase 4 clinical trial evaluating Sci-B-Vac™ for Hepatitis B. Completed, enrolled 91 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 27, 2019
Enrollment StartNov 1, 2015
Primary CompletionFeb 7, 2017
Study CompletionApr 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.6 years ago

Interventions

Sci-B-Vac™biological

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.