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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006743-31 | EudraCT Number |
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The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.
This study will evaluate the safety and efficacy of two injections of HEPLISAV™, compared with three injections of a commercially available hepatitis B virus (HBV) vaccine, Engerix-B®, in subjects 11 to 55 years old. About 2,400 subjects will be included in the study. Once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. Subjects randomized to Engerix-B® will receive 3 injections of active vaccine, while subjects randomized to HEPLISAV™ will receive 2 injections of active vaccine plus 1 injection of placebo. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.
Comparison: Subjects will receive treatment with either HEPLISAV™ or the comparator vaccine, Engerix-B®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEPLISAV and/or Placebo | Experimental | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) |
|
| Engerix-B | Active Comparator | 1.0 mL Engerix-B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEPLISAV and/or Placebo | Biological | Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Seroprotective Immune Response | Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®) | Week 12 for HEPLISAV and Week 28 for Engerix-B |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local and Systemic Reactions to Injections | Within 7 days post-injection for Post Injection Reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Tyler Martin, Sr, MD | Dynavax Technologies Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edmonton | Alberta | Canada | ||||
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| Label | URL |
|---|---|
| Dynavax Webpage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | HEPLISAV and/or Placebo | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0 and Week 4, plus a placebo (saline) injection at Week 24 |
| FG001 | Engerix-B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Engerix-B | Biological | Intramuscular (IM) injections on Week 0, Week 4, and Week 24 |
|
|
| Surrey |
| British Columbia |
| Canada |
| Winnipeg | Manitoba | Canada |
| Mount Pearl | Newfoundland and Labrador | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| Halifax | Nova Scotia | Canada |
| Ottawa | Ontario | Canada |
| Sarnia | Ontario | Canada |
| Toronto | Ontario | Canada |
| Charlottetown | Prince Edward Island | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Berlin | Germany |
| Hamburg | Germany |
| Leipzig | Germany |
| Magdeburg | Germany |
| Munich | Germany |
| Ulm | Germany |
1.0 mL Engerix-B
Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Population: All participants who received at least 1 study injection and had any post-baseline safety data.
NOTE: One (1) subject randomized to the Engerix-B group received HEPLISAV in error and was analyzed in the HEPLSAV group for the Safety Analysis Population
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| ID | Title | Description |
|---|---|---|
| BG000 | HEPLISAV and/or Placebo | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24 |
| BG001 | Engerix-B | 1.0 mL Engerix-B Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 Subjects With Seroprotective Immune Response | Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®) | Per Protocol Population: Subjects who met eligibility criteria, did not violate the protocol in a substantial manner, received all protocol-specified study injections, had their primary serology and all injections within the specified day ranges, and had serology at their primary endpoint (Week 12 for HEPLISAV group and Week 28 for Engerix-B group) | Posted | Number | Percentage of Participants | Week 12 for HEPLISAV and Week 28 for Engerix-B |
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| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Local and Systemic Reactions to Injections | Safety Analysis Population: All participants who received at least 1 study injection and had any post-baseline data. | Posted | Number | Percentage of subjects | Within 7 days post-injection for Post Injection Reactions |
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Adverse events were assessed for safety analysis population: All participants who received at least 1 study injection and had any post-baseline safety data
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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 | HEPLISAV and/or Placebo | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24 | 28 | 1,821 | 602 | 1,821 | ||
| EG001 | Engerix-B | 1.0 mL Engerix-B Engerix-B: Intramuscular (IM) injections on Week 0, Week 4, and Week 24 | 13 | 607 | 191 | 607 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Device dislocation | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
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| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
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| Liver abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Salpingo-oophoritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Guillain-barre syndrome | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Delirium tremens | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Granulomatosis with polyangiitis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Janssen MD \ VP & Chief Medical Officer | Dynavax Technologies, Inc. | 510-848-5100 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Title | Measurements |
|---|---|
|
| Male |
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| Germany |
|
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