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

Hepatitis B Vaccines Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393754
• Other study ID #: Sci-B-Vac-001
• Secondary ID: 2017-001819-36
• Status: Completed
• Phase: Phase 3
• Start date: December 13, 2017
• Est. completion date: April 8, 2019

Study information

• Verified date: July 2020
• Source: VBI Vaccines Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1607
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B Vaccines

Intervention

Biological:
• Hepatitis B Vaccination
Prophylactic Hepatitis B Vaccination

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Gent	Oost-Vlaanderen
Canada	Canadian Center for Vaccinology	Halifax	Nova Scotia
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Québec Université Laval	Quebec
Canada	Medicore Research Inc	Sudbury	Ontario
Canada	BC Children's Hospital Research Institute	Vancouver	British Columbia
Canada	University of Manitoba	Winnipeg	Manitoba
Finland	Espoo Vaccine Research Clinic	Espoo
Finland	Helsinki South Vaccine Research Clinic	Helsinki
Finland	Järvenpää Vaccine Research Clinic	Järvenpää
Finland	Kokkola Vaccine Research Clinic	Kokkola
Finland	Oulu Vaccine Research Clinic	Oulu
Finland	Pori Vaccine Research Clinic	Pori
Finland	Seinäjoki Vaccine Research Clinic	Seinäjoki
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	University of Tampere	Tampere
Finland	Turku Vaccine Research Clinic	Turku
United States	Anaheim Clinical Trials	Anaheim	California
United States	Clinical Research Atlanta	Atlanta	Georgia
United States	Accel Research Sites	Birmingham	Alabama
United States	Advanced Clinical Research	Boise	Idaho
United States	Rapid Medical Research	Cleveland	Ohio
United States	Avail Clinical Research	DeLand	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Suncoast Research Group	Miami	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Advanced Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VBI Vaccines Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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%.	Day 196
Primary	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	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%.	Day 196
Secondary	Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)	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.	Day of vaccine administration and six subsequent days