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)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatitis B Vaccines
- Sponsor
- VBI Vaccines Inc.
- Enrollment
- 1607
- Locations
- 27
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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%.
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%.
Secondary Outcomes
- Percentage of Subject-reporting Solicited Local and Systemic Adverse Events (AEs)(Day of vaccine administration and six subsequent days)