Clinical trial NCT03393754: Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B Vaccines
Keywords: Hepatitis B Vaccines
Lead sponsor: VBI Vaccines Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-08
Enrollment: 1607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Day 196
measure: 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
timeFrame: Day 196
Secondary outcomes:
measure: Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)
timeFrame: Day of vaccine administration and six subsequent days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites
state: Alabama
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Salt Lake City
country: United States
facility: Advanced Clinical Research
state: Utah
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Vancouver
country: Canada
facility: BC Children's Hospital Research Institute
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Sudbury
country: Canada
facility: Medicore Research Inc
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec Université Laval
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Järvenpää
country: Finland
facility: Järvenpää Vaccine Research Clinic
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Seinäjoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
city: Tampere
country: Finland
facility: University of Tampere
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
Study officials:
affiliation: VBI Vaccines
name: Francisco Diaz-Mitoma, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Langley JM, Segall N, Ward BJ, Cooper C, Poliquin G, Smith B, Gantt S, McElhaney JE, Dionne M, van Damme P, Leroux-Roels I, Leroux-Roels G, Machluf N, Spaans JN, Yassin-Rajkumar B, Anderson DE, Popovic V, Diaz-Mitoma F; PROTECT Study Group. Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial. Lancet Infect Dis. 2021 Sep;21(9):1271-1281. doi: 10.1016/S1473-3099(20)30780-5. Epub 2021 May 11.