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

NCT04179786 | Completed Phase 4 Results DMC

• 1 other identifier: SciB018
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis B

Keywords

SciB018; Prophylactic vaccine; Sci-B-Vac™; HepB vaccines; Phase 4; pre-S1; pre-S2; Surface antigen

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 7 (i.e. one month after the third immunization with Sci-B-Vac™)

Secondary Outcomes (3)

• Seroprotection Rates Achieved Monthly During Treatment and Then at Month 7, 9 and 12 During Follow-up

  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

  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

  At one month after the first injection, and then at every month until month 7 inclusive and at months 9 and 12.

Study Arms (1)

Sci-B-Vac™

OTHER

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™

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.

Sci-B-Vac™

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females 20 - 40 years of age.
• Subjects who provided written informed consent to participate in the study.
• Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
• No clinically-significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at Screening.
• Women of child-bearing potential had to practice an acceptable method of birth control or practice abstinence during the study period or be surgically sterilized, from Screening visit throughout the vaccination phase and for 28 days after the last injection and agree to undergo repeated pregnancy tests.
• Subjects had to be able to understand the requirements of the study and willing to comply with the requirements of the study.

You may not qualify if:

• Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the vaccine or may interfere with the subject's compliance or the interpretation of study assessment parameters.
• Any clinically-significant abnormality upon physical examination or in the clinical laboratory tests at Screening visit.
• Treatment with immune suppressive agents.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• History of Hepatitis B virus (HBV) infection or confirmed exposure to HBV
• Previous vaccination against Hepatitis B.
• Positive for HBsAg, anti-HBs antibodies, anti-HBc antibodies, anti-HCV (hepatitis C virus) antibodies or anti- HIV antibodies.
• Drug abuse
• Known hypersensitivity or allergy to any component of the study vaccine.
• Body mass index (BMI) \< 18.5 or ≥ 30 kg/m2.
• Known concomitant disease or any other medical condition that is considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments.
• Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration that is considered of significance by the Principal Investigator.
• Female subjects: pregnant, lactating or planning a pregnancy.
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Receipt of blood or immunoglobulin transfusion six months prior to the first vaccine dose and during the course of the trial.

Sponsors & Collaborators

• VBI Vaccines Inc.: lead

Related Publications (1)

• 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.

  PMID: 33451780 RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Pre-S vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Francisco Diaz-Mitoma
• Organization: VBI Vaccines

fdiazmitoma@vbivaccines.com

1 613 297 3304

Study Officials

• Jacob Atsmon, MD

  TASMC Clinical Research Center (CRC)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was an open-label, single arm study. No control groups were deemed necessary since this was a phase IV trial for which the goal, set according to the European Pharmacopeia 1056, was to achieve 95% SPR after the third vaccination.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: November 27, 2019
• Study Start: November 1, 2015
• Primary Completion: February 7, 2017
• Study Completion: April 25, 2017
• Last Updated: June 24, 2022
• Results First Posted: June 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share