Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was a comparative, randomized, double-blind clinical study of the efficacy and
      safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel
      groups of hepatitis B-naive healthy adult subjects in Russia.
    

Detailed description: 
      This study was a comparative randomized double-blind clinical study of the efficacy and
      safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in hepatitis
      B-naive healthy adult subjects (n = 100). The study was conducted at 3 study sites in the
      Russian Federation. Subjects who passed the screening successfully were randomized into two
      groups, Sci-B-Vac® (10 μg dose) and Engerix-B® (20 μg dose), in a 1:1 ratio. Subjects were
      vaccinated three times at days 1, 28, and 180 of the study.

      Statistical Methods: Evaluation and comparison of immunogenicity were conducted at baseline,
      day 28, day 90 (60 days after the second vaccination), day 180 (prior to administering the
      third vaccine, 90 days after the second vaccination), and day 210 (30 days after the third
      vaccination) of the study.

      The primary outcome was the seroconversion rate (proportion of subjects with anti-HBs levels
      ≥ 2.1 mIU/mL) after the third vaccination at day 210. The non-inferiority margin was set at
      4%. The percentage of subjects who achieved seroconversion was analyzed using the Chi-square
      test for proportions along with the McNemar's test for repeated measurements in each group.
      The non-inferiority hypotheses were confirmed if the lower range of the confidence interval
      was at least -4%. The secondary endpoint was SPR (≥10 mIU/ml), measured at days 1, 28, 90,
      180 and 210.

      Demographic data, initial parameters, safety parameters, tolerance of the experimental
      vaccine, and other study parameters were analyzed using descriptive statistics (mean value,
      standard deviation, median, minimum and maximum values, range, quartiles, the number of valid
      cases-for quantitative variables; absolute number, proportion, allocation-for qualitative
      variables). A comparative assessment of the detection rate for different parameters in the
      two comparison groups was conducted using the Student's t-test; differences were considered
      statistically significant at a significance level of 5%. The assay used to measure anti-HBs
      concentrations had an upper limit of 1000 mIU/mL.
    

Intervention name(s): Sci-B-Vac®; Engerix-B®
Intervention type(s): Biological; Biological
Intervention description(s): Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml; Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sci-B-Vac®; Prophylactic vaccine; HepB vaccines; Phase 3; pre-S1; pre-S2; Surface antigen