ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety of Sci-B-Vac™ to Engerix-B® in Adults ≥ 18 Years Old and Superiority in Adults ≥ 45 Years Old.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03393754
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
VBI Vaccines Inc.

Brief Summary:
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac™ compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac™ compared to Engerix-B® in ≥ 45 years old.

Condition or disease Intervention/treatment Phase
Hepatitis B Vaccines Biological: Hepatitis B Vaccination Phase 3

Detailed Description:
This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac™ compared to Engerix-B® in adults ≥ 45 years old. Study subjects will be randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac™ or 3 injections of Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3 Double-Blind Randomized Controlled Trial to Compare the Immunogenicity and Safety of a Three-dose Regimen of Sci-B-Vac™ to a Three-dose Regimen of Engerix-B® in Adults (PROTECT)
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sci-B-Vac Hepatitis B Vaccination
Sci-B-Vac (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 10ug, IM injection at Days 0, 28, and 168.
Biological: Hepatitis B Vaccination
Prophylactic Hepatitis B Vaccination
Active Comparator: Engerix-B Hepatitis B Vaccination
Engerix-B® (hepatitis B vaccine) Hepatitis B Vaccination, Solution, 20ug, IM injection at Days 0, 28, and 168.
Biological: Hepatitis B Vaccination
Prophylactic Hepatitis B Vaccination



Primary Outcome Measures :
  1. Seroprotection rate at Day 196 in adults ≥ 18 years old [ Time Frame: Day 196 ]
    Seroprotection rate (SPR) achieved on Study Day 196, 4 weeks post-third vaccination with either Sci-B-Vac™ or Engerix-B® in adults ≥18 years old.

  2. Seroprotection rate at Day 196 in adults ≥ 45 years old [ Time Frame: Day 196 ]
    Seroprotection rate (SPR) achieved on Study Day 196, 4 weeks post-third vaccination with either Sci-B-Vac™ or Engerix-B® in adults ≥45 years old.


Secondary Outcome Measures :
  1. Seroprotection rate after Dose 2 [ Time Frame: 4 weeks and 20 weeks, post-second injection ]
    The SPR after 2 doses of Sci-B-Vac (at either 4 or 20 weeks after vaccination) is being compared to the SPR achieved after the 3rd vaccination of Engerix-B (4 weeks after 3rd vaccination).

  2. Number of Subject-reported, solicited, and unsolicited adverse events [ Time Frame: Up to Study Day 336 ]
    Number (%) of subject-reported, solicited (on the day of vaccination and during the next 6 days), unsolicited adverse events (AE) (on the day of vaccination and during the next 27 days), and number (%) of Serious Adverse Events (SAEs), medically significant events or new onset of chronic illness through Study Day 336.

  3. Number of subjects with abnormal vital signs [ Time Frame: Up to Study Day 336 ]
    Number (%) of subjects with abnormal vital signs (including oral temperature, blood pressure (systolic/diastolic), heart rate, and respiratory rate will be assessed at baseline and at each vaccination visit) and/or full physical examination findings, compared to baseline.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any gender.
  • Age ≥ 18 years
  • In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, Chronic Obstructive Pulmonary Disease (COPD) and asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the exclusion criteria. For subjects > 65 years old, Frailty Index ≤3
  • If female, either is not of childbearing potential or is of childbearing potential and must agree to use an adequate birth control method during the screening period and until the end of her participation in the study
  • Able and willing to give consent.

Exclusion Criteria:

  • Previous vaccination with any Hep B vaccine (licensed or experimental).
  • Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or a prednisolone-equivalent dose > 20 mg /day (Inhaled and topical steroids are allowed).
  • Known history of immunological function impairment
  • Pregnancy or breastfeeding
  • Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment
  • Immunization with inactivated vaccines (e.g. influenza) within 2 weeks prior to enrolment
  • Has received blood products or immunoglobulin within 90 days of enrollment or is likely to require blood products during the study period
  • Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment
  • Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF or erythropoietin during the study period
  • Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease.
  • Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
  • History of allergic reactions or anaphylactic reaction to any vaccine component (Engerix-B® or Sci-B-Vac™)
  • Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method
  • Immediate family members of study center staff (parents, sibling, children)
  • Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers at screening
  • Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured
  • Known human immunodeficiency virus (HIV) infection or positive HIV serology at screening
  • Renal impairment at screening
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Any laboratory test abnormality that would be considered of Grade 1 severity and is considered as clinically significant by the investigator. Grade 3 severity or above is exclusionary, regardless of clinical assessment.
  • Diagnosis of advanced stage heart failure or Unstable Angina.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393754


Contacts
Contact: Bebi Yassin-Rajkumar, MS 1-866-574-7034 BYassin-Rajkumar@vbivaccines.com

  Show 27 Study Locations
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
Study Director: Francisco Diaz-Mitoma, MD, PhD VBI Vaccines

Responsible Party: VBI Vaccines Inc.
ClinicalTrials.gov Identifier: NCT03393754     History of Changes
Other Study ID Numbers: Sci-B-Vac-001
2017-001819-36 ( EudraCT Number )
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VBI Vaccines Inc.:
Hepatitis B Vaccines

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs