Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

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: NCT02117934
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : January 10, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Healthy
Interventions Biological: HEPLISAV
Biological: Engerix-B
Enrollment 8374
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HEPLISAV Engerix-B
Hide Arm/Group Description

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

1.0 mL Engerix-B

Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24

Period Title: Overall Study
Started 5592 2782
Completed 5092 2567
Not Completed 500 215
Arm/Group Title HEPLISAV Engerix-B Total
Hide Arm/Group Description

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

1.0 mL Engerix-B

Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24

Total of all reporting groups
Overall Number of Baseline Participants 5587 2781 8368
Hide Baseline Analysis Population Description
Safety Population: All subjects who received at least 1 study injection and who had any post-baseline safety data
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5587 participants 2781 participants 8368 participants
Age ≥ 18 to ≤ 39 years
1132
  20.3%
561
  20.2%
1693
  20.2%
Age ≥ 40 years
4455
  79.7%
2220
  79.8%
6675
  79.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5587 participants 2781 participants 8368 participants
Female
2743
  49.1%
1390
  50.0%
4133
  49.4%
Male
2844
  50.9%
1391
  50.0%
4235
  50.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5587 participants 2781 participants 8368 participants
5587
 100.0%
2781
 100.0%
8368
 100.0%
1.Primary Outcome
Title Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
Hide Description The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor’s office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.
Time Frame Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data
Arm/Group Title HEPLISAV Engerix-B
Hide Arm/Group Description:

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

1.0 mL Engerix-B

Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24

Overall Number of Participants Analyzed 5587 2781
Measure Type: Number
Unit of Measure: percentage of participants
New-onset Immune-mediated Adverse Events 0.1 0.04
Medically-attended Adverse Events 46.0 46.2
Serious Adverse Events 6.2 5.3
2.Primary Outcome
Title Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
Hide Description Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Diabetes Population:Randomized subjects with type 2 diabetes mellitus (clinical diagnosis of T2DM taking at least oral or non-insulin injectable hypoglycemic agent and/or insulin) who received all study injections, had no major protocol deviations, and had anti-HBs levels obtained within the study visit window at Week 28.
Arm/Group Title HEPLISAV Engerix-B
Hide Arm/Group Description:

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

1.0 mL Engerix-B

Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24

Overall Number of Participants Analyzed 640 321
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
90.0
(87.4 to 92.2)
65.1
(59.6 to 70.3)
Time Frame Through Week 56
Adverse Event Reporting Description Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.
 
Arm/Group Title HEPLISAV Engerix-B
Hide Arm/Group Description

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

1.0 mL Engerix-B

Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24

All-Cause Mortality
HEPLISAV Engerix-B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HEPLISAV Engerix-B
Affected / at Risk (%) Affected / at Risk (%)
Total   345/5587 (6.18%)   148/2781 (5.32%) 
Blood and lymphatic system disorders     
Anaemia  1  2/5587 (0.04%)  1/2781 (0.04%) 
Anaemia vitamin b12 deficiency  1  0/5587 (0.00%)  1/2781 (0.04%) 
Leukocytosis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Microcytic anaemia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  1/5587 (0.02%)  0/2781 (0.00%) 
Acute myocardial infarction  1  14/5587 (0.25%)  1/2781 (0.04%) 
Angina pectoris  1  2/5587 (0.04%)  1/2781 (0.04%) 
Angina unstable  1  1/5587 (0.02%)  0/2781 (0.00%) 
Atrial fibrillation  1  6/5587 (0.11%)  3/2781 (0.11%) 
Atrial flutter  1  2/5587 (0.04%)  1/2781 (0.04%) 
Bradycardia  1  2/5587 (0.04%)  0/2781 (0.00%) 
Cardiac arrest  1  3/5587 (0.05%)  0/2781 (0.00%) 
Cardiac failure  1  2/5587 (0.04%)  0/2781 (0.00%) 
Cardiac failure acute  1  1/5587 (0.02%)  0/2781 (0.00%) 
Cardiac failure congestive  1  6/5587 (0.11%)  3/2781 (0.11%) 
Cardiac ventricular thrombosis  1  1/5587 (0.02%)  1/2781 (0.04%) 
Cardio-respiratory arrest  1  1/5587 (0.02%)  1/2781 (0.04%) 
Cardiogenic shock  1  1/5587 (0.02%)  0/2781 (0.00%) 
Cardiomyopathy  1  0/5587 (0.00%)  1/2781 (0.04%) 
Coronary artery disease  1  6/5587 (0.11%)  2/2781 (0.07%) 
Coronary artery occlusion  1  1/5587 (0.02%)  1/2781 (0.04%) 
Coronary artery stenosis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Hypertensive heart disease  1  4/5587 (0.07%)  1/2781 (0.04%) 
Myocardial infarction  1  2/5587 (0.04%)  1/2781 (0.04%) 
Myocardial ischaemia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Pulseless electrical activity  1  1/5587 (0.02%)  0/2781 (0.00%) 
Supraventricular tachycardia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Ventricular fibrillation  1  1/5587 (0.02%)  0/2781 (0.00%) 
Ventricular tachycardia  1  2/5587 (0.04%)  0/2781 (0.00%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/5587 (0.02%)  0/2781 (0.00%) 
Ebstein's anomaly  1  1/5587 (0.02%)  1/2781 (0.04%) 
Sickle cell anaemia with crisis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/5587 (0.02%)  0/2781 (0.00%) 
Vertigo positional  1  1/5587 (0.02%)  1/2781 (0.04%) 
Endocrine disorders     
Inappropriate antidiuretic hormone secretion  1  1/5587 (0.02%)  0/2781 (0.00%) 
Pituitary-dependent cushing's syndrome  1  0/5587 (0.00%)  1/2781 (0.04%) 
Thyroid mass  1  0/5587 (0.00%)  1/2781 (0.04%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Abdominal pain  1  2/5587 (0.04%)  2/2781 (0.07%) 
Appendix disorder  1  1/5587 (0.02%)  0/2781 (0.00%) 
Colitis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Colitis ulcerative  1  1/5587 (0.02%)  0/2781 (0.00%) 
Constipation  1  2/5587 (0.04%)  1/2781 (0.04%) 
Cyclic vomiting syndrome  1  1/5587 (0.02%)  0/2781 (0.00%) 
Diarrhoea  1  1/5587 (0.02%)  0/2781 (0.00%) 
Diverticular perforation  1  2/5587 (0.04%)  1/2781 (0.04%) 
Diverticulum intestinal haemorrhagic  1  1/5587 (0.02%)  0/2781 (0.00%) 
Duodenal ulcer haemorrhage  1  0/5587 (0.00%)  1/2781 (0.04%) 
Gastric ulcer  1  0/5587 (0.00%)  1/2781 (0.04%) 
Gastric ulcer haemorrhage  1  1/5587 (0.02%)  0/2781 (0.00%) 
Gastritis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Gastritis alcoholic  1  1/5587 (0.02%)  0/2781 (0.00%) 
Gastritis alcoholic haemorrhagic  1  1/5587 (0.02%)  0/2781 (0.00%) 
Gastritis haemorrhagic  1  1/5587 (0.02%)  0/2781 (0.00%) 
Gastrointestinal haemorrhage  1  2/5587 (0.04%)  1/2781 (0.04%) 
Gastrooesophageal reflux disease  1  3/5587 (0.05%)  1/2781 (0.04%) 
Ileus  1  1/5587 (0.02%)  0/2781 (0.00%) 
Ileus paralytic  1  1/5587 (0.02%)  0/2781 (0.00%) 
Impaired gastric emptying  1  0/5587 (0.00%)  1/2781 (0.04%) 
Inguinal hernia  1  0/5587 (0.00%)  1/2781 (0.04%) 
Intestinal obstruction  1  0/5587 (0.00%)  1/2781 (0.04%) 
Large intestine perforation  1  1/5587 (0.02%)  1/2781 (0.04%) 
Lower gastrointestinal haemorrhage  1  0/5587 (0.00%)  1/2781 (0.04%) 
Oesophageal spasm  1  1/5587 (0.02%)  0/2781 (0.00%) 
Oesophagitis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Pancreatitis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Pancreatitis acute  1  1/5587 (0.02%)  2/2781 (0.07%) 
Rectal haemorrhage  1  1/5587 (0.02%)  2/2781 (0.07%) 
Rectal prolapse  1  1/5587 (0.02%)  0/2781 (0.00%) 
Small intestinal obstruction  1  6/5587 (0.11%)  2/2781 (0.07%) 
Upper gastrointestinal haemorrhage  1  2/5587 (0.04%)  0/2781 (0.00%) 
Varices oesophageal  1  1/5587 (0.02%)  0/2781 (0.00%) 
General disorders     
Chest pain  1  2/5587 (0.04%)  1/2781 (0.04%) 
Death  1  2/5587 (0.04%)  0/2781 (0.00%) 
Device failure  1  1/5587 (0.02%)  0/2781 (0.00%) 
Drug withdrawal syndrome  1  0/5587 (0.00%)  1/2781 (0.04%) 
Non-cardiac chest pain  1  9/5587 (0.16%)  7/2781 (0.25%) 
Hepatobiliary disorders     
Bile duct stone  1  2/5587 (0.04%)  1/2781 (0.04%) 
Cholecystitis  1  5/5587 (0.09%)  2/2781 (0.07%) 
Cholecystitis acute  1  0/5587 (0.00%)  2/2781 (0.07%) 
Cholecystitis chronic  1  1/5587 (0.02%)  2/2781 (0.07%) 
Cholelithiasis  1  4/5587 (0.07%)  4/2781 (0.14%) 
Hepatic cirrhosis  1  1/5587 (0.02%)  1/2781 (0.04%) 
Ischaemic hepatitis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/5587 (0.02%)  1/2781 (0.04%) 
Infections and infestations     
Abscess limb  1  1/5587 (0.02%)  0/2781 (0.00%) 
Abscess neck  1  1/5587 (0.02%)  0/2781 (0.00%) 
Appendicitis  1  3/5587 (0.05%)  1/2781 (0.04%) 
Appendicitis perforated  1  2/5587 (0.04%)  0/2781 (0.00%) 
Arthritis bacterial  1  1/5587 (0.02%)  0/2781 (0.00%) 
Bacteraemia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Bronchitis  1  3/5587 (0.05%)  0/2781 (0.00%) 
Cellulitis  1  7/5587 (0.13%)  4/2781 (0.14%) 
Cellulitis of male external genital organ  1  1/5587 (0.02%)  0/2781 (0.00%) 
Cellulitis orbital  1  0/5587 (0.00%)  1/2781 (0.04%) 
Cholecystitis infective  1  1/5587 (0.02%)  0/2781 (0.00%) 
Clostridium difficile colitis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Device related infection  1  1/5587 (0.02%)  0/2781 (0.00%) 
Diabetic foot infection  1  2/5587 (0.04%)  1/2781 (0.04%) 
Diverticulitis  1  1/5587 (0.02%)  2/2781 (0.07%) 
Erysipelas  1  0/5587 (0.00%)  1/2781 (0.04%) 
Gastroenteritis  1  4/5587 (0.07%)  1/2781 (0.04%) 
Gastroenteritis viral  1  0/5587 (0.00%)  1/2781 (0.04%) 
Groin abscess  1  1/5587 (0.02%)  1/2781 (0.04%) 
Hepatitis c  1  2/5587 (0.04%)  0/2781 (0.00%) 
Infectious colitis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Influenza  1  2/5587 (0.04%)  1/2781 (0.04%) 
Latent tuberculosis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Lobar pneumonia  1  2/5587 (0.04%)  0/2781 (0.00%) 
Meningitis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Mycobacterium avium complex infection  1  1/5587 (0.02%)  0/2781 (0.00%) 
Osteomyelitis  1  1/5587 (0.02%)  1/2781 (0.04%) 
Otitis media bacterial  1  1/5587 (0.02%)  0/2781 (0.00%) 
Periorbital cellulitis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Perirectal abscess  1  1/5587 (0.02%)  1/2781 (0.04%) 
Pneumonia  1  15/5587 (0.27%)  8/2781 (0.29%) 
Pneumonia escherichia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Pneumonia staphylococcal  1  1/5587 (0.02%)  0/2781 (0.00%) 
Post procedural infection  1  0/5587 (0.00%)  1/2781 (0.04%) 
Postoperative wound infection  1  0/5587 (0.00%)  1/2781 (0.04%) 
Pyelonephritis  1  2/5587 (0.04%)  1/2781 (0.04%) 
Pyelonephritis acute  1  2/5587 (0.04%)  0/2781 (0.00%) 
Sepsis  1  5/5587 (0.09%)  1/2781 (0.04%) 
Splenic abscess  1  1/5587 (0.02%)  0/2781 (0.00%) 
Staphylococcal abscess  1  1/5587 (0.02%)  1/2781 (0.04%) 
Staphylococcal osteomyelitis  1  0/5587 (0.00%)  1/2781 (0.04%) 
Upper respiratory tract infection  1  1/5587 (0.02%)  0/2781 (0.00%) 
Urinary tract infection  1  0/5587 (0.00%)  1/2781 (0.04%) 
Urinary tract infection enterococcal  1  1/5587 (0.02%)  0/2781 (0.00%) 
Urosepsis  1  4/5587 (0.07%)  2/2781 (0.07%) 
Viral sepsis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Wound infection  1  0/5587 (0.00%)  1/2781 (0.04%) 
Wound infection staphylococcal  1  1/5587 (0.02%)  0/2781 (0.00%) 
Injury, poisoning and procedural complications     
Accident  1  1/5587 (0.02%)  0/2781 (0.00%) 
Accidental overdose  1  1/5587 (0.02%)  0/2781 (0.00%) 
Ankle fracture  1  1/5587 (0.02%)  1/2781 (0.04%) 
Arterial injury  1  1/5587 (0.02%)  0/2781 (0.00%) 
Cervical vertebral fracture  1  1/5587 (0.02%)  1/2781 (0.04%) 
Concussion  1  1/5587 (0.02%)  0/2781 (0.00%) 
Craniocerebral injury  1  0/5587 (0.00%)  1/2781 (0.04%) 
Facial bones fracture  1  0/5587 (0.00%)  1/2781 (0.04%) 
Femoral neck fracture  1  0/5587 (0.00%)  2/2781 (0.07%) 
Femur fracture  1  2/5587 (0.04%)  0/2781 (0.00%) 
Foot fracture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Forearm fracture  1  0/5587 (0.00%)  1/2781 (0.04%) 
Gastrointestinal anastomotic leak  1  0/5587 (0.00%)  1/2781 (0.04%) 
Gun shot wound  1  3/5587 (0.05%)  0/2781 (0.00%) 
Hand fracture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Head injury  1  0/5587 (0.00%)  1/2781 (0.04%) 
Hip fracture  1  2/5587 (0.04%)  0/2781 (0.00%) 
Humerus fracture  1  2/5587 (0.04%)  0/2781 (0.00%) 
Intentional overdose  1  1/5587 (0.02%)  0/2781 (0.00%) 
Jaw fracture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Laceration  1  1/5587 (0.02%)  1/2781 (0.04%) 
Lower limb fracture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Lumbar vertebral fracture  1  2/5587 (0.04%)  0/2781 (0.00%) 
Overdose  1  1/5587 (0.02%)  0/2781 (0.00%) 
Patella fracture  1  2/5587 (0.04%)  0/2781 (0.00%) 
Peripheral nerve injury  1  1/5587 (0.02%)  0/2781 (0.00%) 
Post procedural haematoma  1  2/5587 (0.04%)  0/2781 (0.00%) 
Postoperative fever  1  1/5587 (0.02%)  1/2781 (0.04%) 
Postoperative ileus  1  1/5587 (0.02%)  1/2781 (0.04%) 
Procedural intestinal perforation  1  1/5587 (0.02%)  0/2781 (0.00%) 
Procedural pain  1  0/5587 (0.00%)  2/2781 (0.07%) 
Rib fracture  1  2/5587 (0.04%)  0/2781 (0.00%) 
Scapula fracture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Seroma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Spinal fracture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Stab wound  1  1/5587 (0.02%)  0/2781 (0.00%) 
Tibia fracture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Toxicity to various agents  1  5/5587 (0.09%)  1/2781 (0.04%) 
Traumatic haemothorax  1  0/5587 (0.00%)  1/2781 (0.04%) 
Urinary retention postoperative  1  0/5587 (0.00%)  1/2781 (0.04%) 
Wrist fracture  1  0/5587 (0.00%)  1/2781 (0.04%) 
Investigations     
Electrophoresis protein abnormal  1  1/5587 (0.02%)  0/2781 (0.00%) 
Foetal heart rate abnormal  1  0/5587 (0.00%)  1/2781 (0.04%) 
International normalised ratio increased  1  1/5587 (0.02%)  0/2781 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/5587 (0.02%)  3/2781 (0.11%) 
Diabetes mellitus inadequate control  1  2/5587 (0.04%)  1/2781 (0.04%) 
Diabetic ketoacidosis  1  5/5587 (0.09%)  1/2781 (0.04%) 
Dyslipidaemia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Hypoglycaemia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Hypokalaemia  1  2/5587 (0.04%)  2/2781 (0.07%) 
Hyponatraemia  1  2/5587 (0.04%)  0/2781 (0.00%) 
Type 2 diabetes mellitus  1  1/5587 (0.02%)  1/2781 (0.04%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/5587 (0.02%)  1/2781 (0.04%) 
Bursitis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Costochondritis  1  0/5587 (0.00%)  1/2781 (0.04%) 
Flank pain  1  0/5587 (0.00%)  1/2781 (0.04%) 
Intervertebral disc degeneration  1  1/5587 (0.02%)  1/2781 (0.04%) 
Intervertebral disc protrusion  1  1/5587 (0.02%)  0/2781 (0.00%) 
Lumbar spinal stenosis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Muscular weakness  1  1/5587 (0.02%)  0/2781 (0.00%) 
Musculoskeletal chest pain  1  1/5587 (0.02%)  0/2781 (0.00%) 
Myositis  1  0/5587 (0.00%)  1/2781 (0.04%) 
Neck pain  1  0/5587 (0.00%)  1/2781 (0.04%) 
Osteoarthritis  1  7/5587 (0.13%)  3/2781 (0.11%) 
Rhabdomyolysis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Rotator cuff syndrome  1  0/5587 (0.00%)  1/2781 (0.04%) 
Spinal column stenosis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Spinal osteoarthritis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Spondylolisthesis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Vertebral foraminal stenosis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/5587 (0.02%)  1/2781 (0.04%) 
Brain neoplasm benign  1  1/5587 (0.02%)  0/2781 (0.00%) 
Breast cancer  1  2/5587 (0.04%)  0/2781 (0.00%) 
Cervix carcinoma  1  0/5587 (0.00%)  1/2781 (0.04%) 
Cholangiocarcinoma  1  0/5587 (0.00%)  1/2781 (0.04%) 
Clear cell renal cell carcinoma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Colon adenoma  1  2/5587 (0.04%)  0/2781 (0.00%) 
Ductal adenocarcinoma of pancreas  1  1/5587 (0.02%)  0/2781 (0.00%) 
Endometrial cancer  1  1/5587 (0.02%)  0/2781 (0.00%) 
Hodgkin's disease  1  1/5587 (0.02%)  0/2781 (0.00%) 
Intraductal papillary mucinous neoplasm  1  1/5587 (0.02%)  0/2781 (0.00%) 
Intraductal proliferative breast lesion  1  2/5587 (0.04%)  0/2781 (0.00%) 
Invasive ductal breast carcinoma  1  2/5587 (0.04%)  0/2781 (0.00%) 
Lung adenocarcinoma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Lung cancer metastatic  1  1/5587 (0.02%)  0/2781 (0.00%) 
Malignant melanoma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Metastatic renal cell carcinoma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Oesophageal adenocarcinoma  1  0/5587 (0.00%)  1/2781 (0.04%) 
Ovarian cancer stage iii  1  0/5587 (0.00%)  1/2781 (0.04%) 
Ovarian germ cell teratoma  1  0/5587 (0.00%)  1/2781 (0.04%) 
Pancreatic carcinoma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Pancreatic carcinoma metastatic  1  1/5587 (0.02%)  1/2781 (0.04%) 
Papillary thyroid cancer  1  0/5587 (0.00%)  1/2781 (0.04%) 
Pelvic neoplasm  1  1/5587 (0.02%)  0/2781 (0.00%) 
Plasma cell myeloma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Prostate cancer  1  3/5587 (0.05%)  4/2781 (0.14%) 
Prostate cancer stage ii  1  1/5587 (0.02%)  0/2781 (0.00%) 
Rectal adenocarcinoma  1  1/5587 (0.02%)  0/2781 (0.00%) 
Small cell lung cancer metastatic  1  1/5587 (0.02%)  0/2781 (0.00%) 
Squamous cell carcinoma of the cervix  1  1/5587 (0.02%)  0/2781 (0.00%) 
Squamous cell carcinoma of the oral cavity  1  1/5587 (0.02%)  0/2781 (0.00%) 
Uterine leiomyoma  1  1/5587 (0.02%)  2/2781 (0.07%) 
Nervous system disorders     
Carotid artery stenosis  1  2/5587 (0.04%)  1/2781 (0.04%) 
Carotid sinus syndrome  1  0/5587 (0.00%)  1/2781 (0.04%) 
Cauda equina syndrome  1  1/5587 (0.02%)  0/2781 (0.00%) 
Cerebrovascular accident  1  7/5587 (0.13%)  3/2781 (0.11%) 
Cervical myelopathy  1  1/5587 (0.02%)  1/2781 (0.04%) 
Complex partial seizures  1  1/5587 (0.02%)  1/2781 (0.04%) 
Convulsion  1  4/5587 (0.07%)  1/2781 (0.04%) 
Dizziness  1  2/5587 (0.04%)  0/2781 (0.00%) 
Embolic stroke  1  1/5587 (0.02%)  0/2781 (0.00%) 
Haemorrhagic stroke  1  0/5587 (0.00%)  1/2781 (0.04%) 
Headache  1  1/5587 (0.02%)  0/2781 (0.00%) 
Hepatic encephalopathy  1  1/5587 (0.02%)  0/2781 (0.00%) 
Hypoaesthesia  1  0/5587 (0.00%)  1/2781 (0.04%) 
Hypoxic-ischaemic encephalopathy  1  2/5587 (0.04%)  0/2781 (0.00%) 
Ischaemic stroke  1  2/5587 (0.04%)  1/2781 (0.04%) 
Lacunar infarction  1  1/5587 (0.02%)  0/2781 (0.00%) 
Lumbar radiculopathy  1  1/5587 (0.02%)  0/2781 (0.00%) 
Migraine  1  1/5587 (0.02%)  0/2781 (0.00%) 
Neuropathy peripheral  1  1/5587 (0.02%)  0/2781 (0.00%) 
Radial nerve palsy  1  1/5587 (0.02%)  0/2781 (0.00%) 
Spondylitic myelopathy  1  0/5587 (0.00%)  1/2781 (0.04%) 
Subarachnoid haemorrhage  1  1/5587 (0.02%)  0/2781 (0.00%) 
Syncope  1  2/5587 (0.04%)  4/2781 (0.14%) 
Thalamic infarction  1  1/5587 (0.02%)  0/2781 (0.00%) 
Thrombotic stroke  1  0/5587 (0.00%)  1/2781 (0.04%) 
Transient global amnesia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Transient ischaemic attack  1  4/5587 (0.07%)  1/2781 (0.04%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  3/5587 (0.05%)  2/2781 (0.07%) 
Foetal growth restriction  1  1/5587 (0.02%)  0/2781 (0.00%) 
Gestational diabetes  1  1/5587 (0.02%)  0/2781 (0.00%) 
Oligohydramnios  1  0/5587 (0.00%)  1/2781 (0.04%) 
Placenta praevia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Psychiatric disorders     
Bipolar disorder  1  3/5587 (0.05%)  1/2781 (0.04%) 
Bipolar i disorder  1  4/5587 (0.07%)  0/2781 (0.00%) 
Confusional state  1  0/5587 (0.00%)  1/2781 (0.04%) 
Delirium  1  1/5587 (0.02%)  0/2781 (0.00%) 
Depression  1  5/5587 (0.09%)  1/2781 (0.04%) 
Depression suicidal  1  1/5587 (0.02%)  0/2781 (0.00%) 
Mental status changes  1  3/5587 (0.05%)  1/2781 (0.04%) 
Schizoaffective disorder  1  1/5587 (0.02%)  0/2781 (0.00%) 
Schizophrenia  1  1/5587 (0.02%)  0/2781 (0.00%) 
Substance-induced psychotic disorder  1  0/5587 (0.00%)  1/2781 (0.04%) 
Suicidal ideation  1  3/5587 (0.05%)  1/2781 (0.04%) 
Suicide attempt  1  3/5587 (0.05%)  1/2781 (0.04%) 
Renal and urinary disorders     
Acute prerenal failure  1  1/5587 (0.02%)  0/2781 (0.00%) 
Bladder disorder  1  0/5587 (0.00%)  1/2781 (0.04%) 
Calculus ureteric  1  4/5587 (0.07%)  2/2781 (0.07%) 
Nephrolithiasis  1  0/5587 (0.00%)  1/2781 (0.04%) 
Prerenal failure  1  1/5587 (0.02%)  0/2781 (0.00%) 
Renal failure  1  0/5587 (0.00%)  1/2781 (0.04%) 
Renal failure acute  1  4/5587 (0.07%)  3/2781 (0.11%) 
Renal failure chronic  1  2/5587 (0.04%)  0/2781 (0.00%) 
Tubulointerstitial nephritis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Urinary retention  1  0/5587 (0.00%)  2/2781 (0.07%) 
Reproductive system and breast disorders     
Adenomyosis  1  0/5587 (0.00%)  2/2781 (0.07%) 
Cystocele  1  1/5587 (0.02%)  0/2781 (0.00%) 
Dysfunctional uterine bleeding  1  1/5587 (0.02%)  0/2781 (0.00%) 
Postmenopausal haemorrhage  1  0/5587 (0.00%)  1/2781 (0.04%) 
Prostatitis  1  0/5587 (0.00%)  1/2781 (0.04%) 
Vaginal haemorrhage  1  0/5587 (0.00%)  1/2781 (0.04%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/5587 (0.02%)  1/2781 (0.04%) 
Acute respiratory failure  1  6/5587 (0.11%)  1/2781 (0.04%) 
Asthma  1  5/5587 (0.09%)  1/2781 (0.04%) 
Chronic obstructive pulmonary disease  1  9/5587 (0.16%)  3/2781 (0.11%) 
Diaphragmatic paralysis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Diaphragmatic rupture  1  1/5587 (0.02%)  0/2781 (0.00%) 
Dyspnoea  1  2/5587 (0.04%)  0/2781 (0.00%) 
Haemothorax  1  1/5587 (0.02%)  0/2781 (0.00%) 
Hiccups  1  1/5587 (0.02%)  0/2781 (0.00%) 
Hypoxia  1  2/5587 (0.04%)  0/2781 (0.00%) 
Lung infiltration  1  1/5587 (0.02%)  0/2781 (0.00%) 
Nasal polyps  1  1/5587 (0.02%)  0/2781 (0.00%) 
Pleural effusion  1  2/5587 (0.04%)  0/2781 (0.00%) 
Pleuritic pain  1  1/5587 (0.02%)  0/2781 (0.00%) 
Pneumonia aspiration  1  1/5587 (0.02%)  1/2781 (0.04%) 
Pneumothorax  1  4/5587 (0.07%)  1/2781 (0.04%) 
Pulmonary embolism  1  3/5587 (0.05%)  2/2781 (0.07%) 
Pulmonary oedema  1  1/5587 (0.02%)  0/2781 (0.00%) 
Respiratory arrest  1  0/5587 (0.00%)  1/2781 (0.04%) 
Respiratory failure  1  1/5587 (0.02%)  2/2781 (0.07%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  1/5587 (0.02%)  2/2781 (0.07%) 
Hidradenitis  1  1/5587 (0.02%)  0/2781 (0.00%) 
Social circumstances     
Victim of homicide  1  1/5587 (0.02%)  0/2781 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  2/5587 (0.04%)  0/2781 (0.00%) 
Aortic stenosis  1  0/5587 (0.00%)  1/2781 (0.04%) 
Deep vein thrombosis  1  4/5587 (0.07%)  3/2781 (0.11%) 
Hypertension  1  5/5587 (0.09%)  3/2781 (0.11%) 
Hypertensive crisis  1  2/5587 (0.04%)  0/2781 (0.00%) 
Hypotension  1  2/5587 (0.04%)  2/2781 (0.07%) 
Peripheral vascular disorder  1  1/5587 (0.02%)  0/2781 (0.00%) 
Thrombophlebitis superficial  1  1/5587 (0.02%)  0/2781 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
HEPLISAV Engerix-B
Affected / at Risk (%) Affected / at Risk (%)
Total   1097/5587 (19.63%)   549/2781 (19.74%) 
Infections and infestations     
Acute sinusitis  1  59/5587 (1.06%)  37/2781 (1.33%) 
Bronchitis  1  174/5587 (3.11%)  102/2781 (3.67%) 
Sinusitis  1  149/5587 (2.67%)  84/2781 (3.02%) 
Upper respiratory tract infection  1  191/5587 (3.42%)  92/2781 (3.31%) 
Urinary tract infection  1  132/5587 (2.36%)  63/2781 (2.27%) 
Metabolism and nutrition disorders     
Type 2 diabetes mellitus  1  66/5587 (1.18%)  36/2781 (1.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  98/5587 (1.75%)  54/2781 (1.94%) 
Back pain  1  115/5587 (2.06%)  54/2781 (1.94%) 
Musculoskeletal pain  1  45/5587 (0.81%)  30/2781 (1.08%) 
Osteoarthritis  1  72/5587 (1.29%)  30/2781 (1.08%) 
Pain in extremity  1  72/5587 (1.29%)  28/2781 (1.01%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  62/5587 (1.11%)  37/2781 (1.33%) 
Vascular disorders     
Hypertension  1  128/5587 (2.29%)  57/2781 (2.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigator may communicate study results with prior written consent from Dynavax.
Results Point of Contact
Name/Title: Robert Janssen MD \ VP & Chief Medical Officer
Organization: Dynavax Technologies, Inc.
Phone: 510-848-5100
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT02117934     History of Changes
Other Study ID Numbers: DV2-HBV-23
First Submitted: April 15, 2014
First Posted: April 21, 2014
Results First Submitted: December 8, 2017
Results First Posted: January 10, 2018
Last Update Posted: March 20, 2019