Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    PROTECT Sci-B-Vac
Previous Study | Return to List | Next Study

Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393754
Recruitment Status : Completed
First Posted : January 8, 2018
Results First Posted : July 7, 2020
Last Update Posted : July 17, 2020
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 are 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1607 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
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine


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 (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 [ Time Frame: Day 196 ]
    To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is non-inferior to a three-dose regimen of Engerix-B® in adults ≥18 years old; i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after the third vaccination, will be > - 5%.

  2. Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 45 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 [ Time Frame: Day 196 ]
    To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac® is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided CI of the difference between the SPR in the Sci-B-Vac® arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after receiving the third vaccination, will be > 5%.


Secondary Outcome Measures :
  1. Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Day of vaccine administration and six subsequent days ]
    Analysis of local and systemic solicited adverse events with an interval of onset of Day 1 to Day 7 after any vaccination with either Sci-B-Vac® or Engerix-B®, in adults ≥18 years old.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Locations
Show Show 28 study locations
Sponsors and Collaborators
VBI Vaccines Inc.
Investigators
Layout table for investigator information
Study Director: Francisco Diaz-Mitoma, MD, PhD VBI Vaccines
  Study Documents (Full-Text)

Documents provided by VBI Vaccines Inc.:
Study Protocol  [PDF] July 17, 2017
Statistical Analysis Plan  [PDF] May 13, 2019

Layout table for additonal information
Responsible Party: VBI Vaccines Inc.
ClinicalTrials.gov Identifier: NCT03393754    
Other Study ID Numbers: Sci-B-Vac-001
2017-001819-36 ( EudraCT Number )
First Posted: January 8, 2018    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 17, 2020
Last Verified: July 2020

Layout table for additional information
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:
Layout table for MeSH terms
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs