Trial Outcomes & Findings for Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine (NCT NCT01005407)
NCT ID: NCT01005407
Last Updated: 2019-03-20
Results Overview
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2452 participants
Primary outcome timeframe
at Week 12 and at Week 32
Results posted on
2019-03-20
Participant Flow
Participant milestones
| Measure |
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
|
Engerix-B
1.0 mL Engerix-B
Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24
|
|---|---|---|
|
Overall Study
STARTED
|
1969
|
483
|
|
Overall Study
COMPLETED
|
1818
|
451
|
|
Overall Study
NOT COMPLETED
|
151
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Baseline characteristics by cohort
| Measure |
HEPLISAV and Placebo
n=1968 Participants
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
|
Engerix-B
n=481 Participants
1.0 mL Engerix-B
Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24
|
Total
n=2449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≥ 40 to ≤ 70 years
|
1968 Participants
n=5 Participants
|
481 Participants
n=7 Participants
|
2449 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1025 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
1270 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
943 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
1179 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
151 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1817 Participants
n=5 Participants
|
436 Participants
n=7 Participants
|
2253 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at Week 12 and at Week 32Population: Non-Inferiority per Protocol population:Randomized subjects who received 1 of 3 consistency lots of HEPLISAV or Engerix-B within the study visit windows, had all 3 study injections as randomized and within the study visit windows, no major protocol deviations, and anti-HBs levels obtained within study visit windows at baseline, Week 12, and Week 32
Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®
Outcome measures
| Measure |
HEPLISAV and Placebo
n=1121 Participants
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
|
Engerix-B
n=353 Participants
1.0 mL Engerix-B
Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24
|
|---|---|---|
|
Percentage of Subjects Who Have a Seroprotective Immune Response
|
90.1 Percentage of participants
|
70.5 Percentage of participants
|
SECONDARY outcome
Timeframe: within 7 days for post-injection reactionsPopulation: Safety population: All participants who received at least 1 study injection and had at least 1 post-baseline safety data. NOTE: Only subjects with non-missing injection results in the Safety population are included in this analysis.
Outcome measures
| Measure |
HEPLISAV and Placebo
n=1952 Participants
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
|
Engerix-B
n=477 Participants
1.0 mL Engerix-B
Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24
|
|---|---|---|
|
Percentage of Participants With Local and Systemic Reaction to Injections
Systemic reaction: Injection 3
|
0 percentage of participants
|
13.39 percentage of participants
|
|
Percentage of Participants With Local and Systemic Reaction to Injections
Local reaction: Injection 1
|
24.33 percentage of participants
|
18.87 percentage of participants
|
|
Percentage of Participants With Local and Systemic Reaction to Injections
Local reaction: Injection 2
|
23.10 percentage of participants
|
16.16 percentage of participants
|
|
Percentage of Participants With Local and Systemic Reaction to Injections
Local reaction: Injection 3
|
0 percentage of participants
|
13.84 percentage of participants
|
|
Percentage of Participants With Local and Systemic Reaction to Injections
Systemic reaction: Injection 1
|
22.34 percentage of participants
|
22.64 percentage of participants
|
|
Percentage of Participants With Local and Systemic Reaction to Injections
Systemic reaction: Injection 2
|
16.38 percentage of participants
|
18.10 percentage of participants
|
Adverse Events
HEPLISAV and/or Placebo
Serious events: 78 serious events
Other events: 80 other events
Deaths: 0 deaths
Engerix-B(1)
Serious events: 23 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HEPLISAV and/or Placebo
n=1968 participants at risk
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
|
Engerix-B(1)
n=481 participants at risk
1.0 mL Engerix-B
Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Angina pectoris
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Atrial fibrillation
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Cardiomyopathy
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Ear and labyrinth disorders
Vertigo
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Haematemesis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
General disorders
Chest pain
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
General disorders
Non-cardiac chest pain
|
0.15%
3/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Hepatobiliary disorders
Cholecystitis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Cavernous sinus thrombosis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Diverticulitis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Localised infection
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Perirectal abscess
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Pneumonia
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Post procedural infection
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Infections and infestations
Staphylococcal infection
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Contusion
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Metabolism and nutrition disorders
Water intoxication
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
4/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.46%
9/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.42%
2/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage iv
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory carcinoma of the breast
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.62%
3/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Psychiatric disorders
Major depression
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Reproductive system and breast disorders
Endometriosis
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
2/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.21%
1/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
|
Vascular disorders
Hypertension
|
0.05%
1/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
0.00%
0/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
Other adverse events
| Measure |
HEPLISAV and/or Placebo
n=1968 participants at risk
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
|
Engerix-B(1)
n=481 participants at risk
1.0 mL Engerix-B
Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.1%
80/1968
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
5.2%
25/481
Adverse events were assessed for the safety analysis population: All participants who received at least 1 study injection and had a least 1 post baseline safety data
|
Additional Information
Robert Janssen MD \ VP & Chief Medical Officer
Dynavax Technologies, Inc.
Phone: 510-848-5100
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60