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This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response. Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine
This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam. Following a screening period, healthy eligible subjects (n = 402) were enrolled and randomized to receive Sci-B-Vac (OLD facility (Lot A) and NEW facility (Lot B), or Engerix-B.
The study was conducted in two stages, approximately a year-and-a-half apart. In the first stage (Stage I) beginning in March 2006, Sci-B-Vac (Lot A) vaccine was compared to Engerix-B; and in the second stage (Stage II) beginning in November 2007, the Sci-B-Vac (Lot B) vaccine was compared to Engerix-B. The subjects assigned to the Engerix-B group were equally divided between the stages, 67 subjects in the Engerix-B group in Stages I and II, respectively, for a total of 134 subjects, such that the final number of randomized subjects in Stage 1 and Stage 2 across the Sci-B-Vac Lot A, Sci-B-Vac Lot B and Engerix-B was 1:1:1, respectively. Immunogenicity evaluations for Stage I data (Visits 5 and 6) were conducted together with Stage II data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sci-B-Vac-SciGen | Experimental | The 3-antigen HepB vaccine, Sci-B-Vac-SciGen (SciGen Israel Ltd., produced in a new production facility located in Rehovot, Israel) contains three recombinant proteins of hepatitis B virus (HBV) envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac-SciGen was supplied in a final volume of 1.2 ml vials |
|
| Engerix-B | Active Comparator | The single antigen HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein. Engerix-B was supplied in 1.0 ml vials. |
|
| Sci-B-Vac-BTG | Experimental | The 3-antigen HepB vaccine, Sci-B-Vac-BTG (Bio-Technology General (BTG) Ltd., Rehovot, Israel.) contains three recombinant proteins of HBV viral envelope: small S, medium pre-S2, and large pre-S1 surface antigens. Sci-B-Vac-BTG was supplied in a final volume of 1.2 ml vials |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sci-B-Vac-Lot B | Biological | Sci-B-Vac Lot B -10 μg of HBsAg, intramuscular injection of 10 μg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination | Percentage of participants with an antibody response to hepatitis B surface antigens (anti-HBs), defined as an anti-HBs titer ≥10 IU/liter, one month after the third vaccination (Day 210) in the According-to-Protocol (ATP) population. | Day 210 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360. | Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥10 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population. | Days 180, 210, and 360 |
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Inclusion Criteria:
Healthy adults 18 to 45 years of age who were seronegative for HBsAg, anti-HBs, anti-Hepatitis B core antigen, HIV, and Hepatitis C Virus (HCV)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Do G Canh, MD | National Institute of Hygiene and Epidemiology (NIHE), Hanoi, Vietnam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Hygiene and Epidemiology (NIHE) | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34116873 | Derived | Diaz-Mitoma F, Popovic V, Spaans JN. Assessment of immunogenicity and safety across two manufacturing lots of a 3-antigen hepatitis B vaccine, Sci-B-Vac(R), compared with Engerix-B(R) in healthy Asian adults: A phase 3 randomized clinical trial. Vaccine. 2021 Jun 29;39(29):3892-3899. doi: 10.1016/j.vaccine.2021.05.067. Epub 2021 Jun 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sci-B-Vac-Lot B | The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml |
| FG001 | Engerix-B | The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials. |
| FG002 | Sci-B-Vac-Lot A | The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage I |
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| Stage II |
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Safety was evaluated in all study participants who received at least one vaccination and for whom there was safety information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sci-B-Vac-Lot B | The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml |
| BG001 | Engerix-B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Available Observations |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination | Percentage of participants with an antibody response to hepatitis B surface antigens (anti-HBs), defined as an anti-HBs titer ≥10 IU/liter, one month after the third vaccination (Day 210) in the According-to-Protocol (ATP) population. | The according-to-protocol (ATP) population included all participants who received the three vaccinations, the third vaccination measurement of anti-HBs titers, and had no major protocol violations. | Posted | Count of Participants | Participants | Day 210 |
|
Subjects were assessed for safety at baseline, during treatment (Day 30, Day 180) and during follow up (Day 210, Day 310).
Adverse events (AEs) were reported throughout the study and were rated by the investigator for severity and causality. All serious AEs (SAEs) and fatalities were reported immediately. Local and systemic solicited adverse reactions were recorded after each vaccination on participant diary cards. AEs were rated by the investigators for severity and causality. All fatalities and SAE were reported to SciGen Ltd and Pharmacovigilance of Quintiles Asia Pacific, Singapore.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sci-B-Vac-Lot B | The 3-antigen HepB vaccine, Sci-B-Vac-Lot B (SciGen Israel Ltd., New Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| schizophrenia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francisco Diaz-Mitoma | VBI Vaccines | 1 613 297 3304 | fdiazmitoma@vbivaccines.com |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C000608755 | Pre-S vaccine |
| C075654 | Engerix-B |
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Single blind, three-arm, two-stage, randomized study
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| Sci-B-Vac-Lot A | Biological | Sci-B-Vac Lot A - 10 μg of HBsAg, intramuscular injection of 10 μg/ml |
|
|
| Engerix-B | Biological | Engerix-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection |
|
| Anti-HBs Geometric Mean Concentration (GMC) | Geometric mean concentration (GMC) of anti-HBs antibody just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population. | Days 180, 210, and 360 |
| Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360. | Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥100 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population. | Days 180, 210 and 360 |
| Withdrawal by Subject |
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| NOT COMPLETED |
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|
The mono-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials.
| BG002 | Sci-B-Vac-Lot A | The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Available Observations | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Available Observations | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ethnic Group | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Smoking status | Count of Participants | Participants |
|
| OG001 |
| Engerix-B |
The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials. |
| OG002 | Sci-B-Vac-Lot A | The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml |
|
|
| Secondary | Percentage of Participants With an Anti-HBs Antibody Titer ≥10 IU/Liter at Days 180, 210 and 360. | Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥10 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population. | The according-to-protocol (ATP) population included all participants who received the three vaccinations, the third vaccination measurement of anti-HBs titers, and had no major protocol violations. | Posted | Count of Participants | Participants | Days 180, 210, and 360 |
|
|
|
| Secondary | Anti-HBs Geometric Mean Concentration (GMC) | Geometric mean concentration (GMC) of anti-HBs antibody just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population. | The according-to-protocol (ATP) population included all participants who received the three vaccinations, the third vaccination measurement of anti-HBs titers, and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | IU/Liter | Days 180, 210, and 360 |
|
|
|
| Secondary | Percentage of Participants With an Anti-HBs Antibody Titer ≥100 IU/Liter at Days 180, 210 and 360. | Percentage of participants with an anti-HBs antibody response, defined as an anti-HBs titer ≥100 IU/liter, just prior to the third vaccination (Day 180) and 1 month (Day 210) and 6 months (Day 360) after the third vaccination in the According-to-Protocol (ATP) population. | The according-to-protocol (ATP) population included all participants who received the three vaccinations, the third vaccination measurement of anti-HBs titers, and had no major protocol violations. | Posted | Count of Participants | Participants | Days 180, 210 and 360 |
|
|
|
| 0 |
| 131 |
| 1 |
| 131 |
| 63 |
| 131 |
| EG001 | Engerix-B | The single-antigenic HepB vaccine, Engerix-B (GSK), contains the small S recombinant protein indicated for active immunization against hepatitis B virus infection. Engerix-B was supplied in 1.0 ml vials. | 0 | 133 | 4 | 133 | 26 | 133 |
| EG002 | Sci-B-Vac-Lot A | The 3-antigen HepB vaccine, Sci-B-Vac-Lot A (Bio-Technology General (BTG) Ltd., Old Facility) contains10 μg of HBsAg/preS1/S2 injected intramuscularly at 10 μg/ml | 0 | 134 | 3 | 134 | 83 | 134 |
| ilium fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| osteitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| hepatitis B | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| gastritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| anemia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dizziness | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Day 210 |
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| Day 360 |
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| Day 210 |
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| Day 360 |
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| Day 210 |
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| Day 360 |
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