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Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209400
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
VBI Vaccines Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Sci-B-Vac® Biological: Engerix-B® Phase 3

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 was conducted at baseline, days 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%.

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparative Randomized Double-Blind Study of Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® in Adult Study Subjects
Actual Study Start Date : April 18, 2014
Actual Primary Completion Date : April 20, 2015
Actual Study Completion Date : April 20, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sci-B-Vac®
The third-generation HepB vaccine, Sci-B-Vac® contains three recombinant proteins of HBV viral envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac® was supplied in 1.0 ml vials.
Biological: Sci-B-Vac®
Sci-B-Vac® vaccine—10 μg of HBsAg, intramuscular injection of 10 μg/ml

Active Comparator: Engerix-B®
The second-generation HepB vaccine, Engerix-B® (GSK), contains the small S recombinant protein. Engerix-B® was supplied in 1.0 ml vials.
Biological: Engerix-B®
Engerix-B® vaccine—20 μg of HBsAg, intramuscular injection of 20 μg/ml




Primary Outcome Measures :
  1. Seroconversion rate [ Time Frame: Day 210 ]
    Percentage of subjects with anti-HBs titer ≥ 2.1 mIU/mL


Secondary Outcome Measures :
  1. Seroprotection Rate [ Time Frame: Days 1, 28, 90, 180, 210 ]
    SPR was defined as the percentage of subjects with anti-HBs titer level ≥10 mIU/mL

  2. Seroconversion Rate [ Time Frame: Days 1, 28, 90, 180 ]
    Seroconversion Rate was defined as the percentage of subjects with anti-HBs titer level ≥2.1 mIU/mL

  3. Geometric mean concentrations (GMC) of HBs antibodies [ Time Frame: Days 1, 28, 90, 180, and 210 ]
    All visits

  4. Concentration of HBs antibodies [ Time Frame: Days 1, 28, 90, 180, and 210 ]
    All visits


Other Outcome Measures:
  1. Adverse Events: Local reactions at the injection site- rate of Redness [ Time Frame: Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210 ]

    Redness at the injection site reported within 5-days after vaccination was evaluated on a scale of 0 to 4 as:

    • No erythema (0);
    • Extremely mild erythema (1);
    • Clearly defined erythema (2);
    • Mild to moderate erythema (3);
    • Apparent erythema prior to preventing the formation of the scab (4)

  2. Adverse Events: Local reactions at the injection site- intensity of Redness [ Time Frame: Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210 ]

    Severity/intensity of rash was evaluated on a scale from 0 to 3 and documented in the Individual Registration Chart as follows:

    Absence of symptoms (0); Mild discomfort (1); Causes discomfort and impairs normal activity (2); Prevents normal activity (3)


  3. Adverse Events: Local reactions at the injection site- intensity of Itch [ Time Frame: Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210 ]

    Severity of itch was evaluated on a scale from 0 to 3 and documented in the Individual Registration Chart as follows:

    Absence of symptoms (0); Mild discomfort (1); Causes discomfort and impairs normal activity (2); Prevents normal activity (3)


  4. Adverse Events: Local reactions at the injection site- rate of Itch [ Time Frame: Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210 ]

    Rate of itch was evaluated on a scale from 0 to 3 and documented in the Individual Registration Chart as follows:

    Absence of symptoms (0); Mild discomfort (1); Causes discomfort and impairs normal activity (2); Prevents normal activity (3)


  5. Adverse Events: Local reactions at the injection site-rate of Pain [ Time Frame: Days 1, 28, 180, 182 ]
    Pain was evaluated by the subject using the visual analogue scale. A higher score indicates greater pain intensity

  6. Adverse Events: Local reactions at the injection site-intensity of Pain [ Time Frame: Days 1, 28, 180, 182 ]
    Pain was evaluated by the subject using the visual analogue scale. A higher score indicates greater pain intensity

  7. Systemic Adverse Events [ Time Frame: Days 1-5, Days 28-32, Day 90, Days 180-185, Day 210 ]

    Feeling not well overall, arthralgia, and myalgia were evaluated on a scale from 0 to 3 and documented in the Individual Registration Chart as follows:

    Absence of symptoms (0); Mild discomfort (1); Causes discomfort and impairs normal activity (2); Prevents normal activity (3)


  8. Serious Adverse Events [ Time Frame: Days 1-210 ]
    Rate, intensity, and association with vaccination of all serious adverse events were evaluated

  9. Clinical and laboratory testing data [ Time Frame: Days 1,3, 28,30,90,180,182,210 ]
    All abnormal results of lab tests or diagnostic procedures (checkup of vital signs, physical examination, etc.) that are considered clinically significant were documented as adverse events on day of injection and two days after, in addition to Day 90 and 210.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Availability of written Informed Consent to participate in the study from the subject.
  2. Male of female between 18 and 45 years old without previous contact with hepatitis B virus (HBV).
  3. Good health condition based on full physical examination.
  4. Normal values of laboratory biochemical blood tests.
  5. Seronegative with respect to anti-HBs (surface) antibodies, anti-HBc (core) antibodies, and HBs Antigen (HBsAg) on screening.
  6. Not pregnant and not breast-feeding.
  7. For men and women of reproductive age: consent for use of an effective contraception method, for example, an intrauterine device, oral contraceptive, hypodermic implant or double barrier method (a condom with contraceptive sponge or contraceptive suppository) throughout the entire study.

Exclusion Criteria:

  1. Congenital or inherited immunodeficiency disorder in family history.
  2. Information of a serious blood disorder, cardiac disorder, or tumour.
  3. Current use of any medication that could alter immune reactivity.
  4. Infection with HBV at the present time or in the past, confirmed by HBV markers test.
  5. Anaphylaxis or severe allergy, or atopy, history of alcoholism or drug abuse.
  6. Pregnancy and breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209400


Locations
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Russian Federation
Saint Petersburg State Budgetary Healthcare Institution
Saint Petersburg, Mirgorodskaya, Russian Federation, 191167
Sponsors and Collaborators
VBI Vaccines Inc.
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Responsible Party: VBI Vaccines Inc.
ClinicalTrials.gov Identifier: NCT04209400    
Other Study ID Numbers: 38-13-040 RUS
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VBI Vaccines Inc.:
Sci-B-Vac®
Prophylactic vaccine
HepB vaccines
Phase 3
pre-S1
pre-S2
Surface antigen
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections