A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™

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.

Timeline

Start

2015-11-01

Primary completion

2017-02-07

Completion

2017-04-25

Publications

• Results Atsmon J, Machluf N, Yayon-Gur V, Sabbah C, Spaans JN, Yassin-Rajkumar B, Anderson DE, Popovic V, Diaz-Mitoma F. Rapid and high seroprotection rates achieved with a tri-antigenic Hepatitis B vaccine in healthy young adults: Results from a Phase IV study. Vaccine. 2021 Feb 22;39(8):1328-1332. doi: 10.1016/j.vaccine.2020.12.050. Epub 2021 Jan 13.

Drugs

Indications