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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,607
Prophylactic Hepatitis B Vaccination
Accel Research Sites
Birmingham, Alabama, United States
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%.
Time frame: Day 196
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%.
Time frame: Day 196
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.
Time frame: Day of vaccine administration and six subsequent days
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