Healthy
Conditions
Keywords
HBV vaccine, Hepatitis B vaccine, Hepatitis B, Hepatitis, HBV, Prevention & Control, Healthy, Healthy volunteers
Brief summary
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Detailed description
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
Interventions
BIOLOGICALHEPLISAV and/or Placebo
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
BIOLOGICALEngerix-B
Intramuscular (IM) injections on Week 0, Week 4 and Week 24
Sponsors
Dynavax Technologies Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* be 40 - 70 years of age, inclusive * be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV) * be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation * if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection
Exclusion criteria
* if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy * has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner * has a known history of autoimmune disease * has previously received any hepatitis B vaccine (approved or investigational)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Have a Seroprotective Immune Response | at Week 12 and at 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® |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Local and Systemic Reaction to Injections | within 7 days for post-injection reactions |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEPLISAV and 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 | 1,968 |
| Engerix-B 1.0 mL Engerix-B
Engerix-B: Intramuscular (IM) injections on Week 0, Week 4 and Week 24 | 481 |
| Total | 2,449 |
Baseline characteristics
| Characteristic | Total | HEPLISAV and Placebo | Engerix-B |
|---|---|---|---|
| Age, Customized ≥ 40 to ≤ 70 years | 2449 Participants | 1968 Participants | 481 Participants |
| Region of Enrollment Canada | 196 Participants | 151 Participants | 45 Participants |
| Region of Enrollment United States | 2253 Participants | 1817 Participants | 436 Participants |
| Sex: Female, Male Female | 1270 Participants | 1025 Participants | 245 Participants |
| Sex: Female, Male Male | 1179 Participants | 943 Participants | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 80 / 1,968 | 25 / 481 |
| serious Total, serious adverse events | 78 / 1,968 | 23 / 481 |
Outcome results
Primary
Percentage of Subjects Who Have a Seroprotective Immune Response
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®
Time frame: at Week 12 and at Week 32
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEPLISAV and Placebo | Percentage of Subjects Who Have a Seroprotective Immune Response | 90.1 Percentage of participants |
| Engerix-B | Percentage of Subjects Who Have a Seroprotective Immune Response | 70.5 Percentage of participants |
Secondary
Percentage of Participants With Local and Systemic Reaction to Injections
Time frame: within 7 days for post-injection reactions
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HEPLISAV and Placebo | Percentage of Participants With Local and Systemic Reaction to Injections | Local reaction: Injection 3 | 0 percentage of participants |
| HEPLISAV and Placebo | Percentage of Participants With Local and Systemic Reaction to Injections | Local reaction: Injection 1 | 24.33 percentage of participants |
| HEPLISAV and Placebo | Percentage of Participants With Local and Systemic Reaction to Injections | Local reaction: Injection 2 | 23.10 percentage of participants |
| HEPLISAV and Placebo | Percentage of Participants With Local and Systemic Reaction to Injections | Systemic reaction: Injection 1 | 22.34 percentage of participants |
| HEPLISAV and Placebo | Percentage of Participants With Local and Systemic Reaction to Injections | Systemic reaction: Injection 2 | 16.38 percentage of participants |
| HEPLISAV and Placebo | Percentage of Participants With Local and Systemic Reaction to Injections | Systemic reaction: Injection 3 | 0 percentage of participants |
| Engerix-B | Percentage of Participants With Local and Systemic Reaction to Injections | Systemic reaction: Injection 2 | 18.10 percentage of participants |
| Engerix-B | Percentage of Participants With Local and Systemic Reaction to Injections | Systemic reaction: Injection 1 | 22.64 percentage of participants |
| Engerix-B | Percentage of Participants With Local and Systemic Reaction to Injections | Local reaction: Injection 1 | 18.87 percentage of participants |
| Engerix-B | Percentage of Participants With Local and Systemic Reaction to Injections | Systemic reaction: Injection 3 | 13.39 percentage of participants |
| Engerix-B | Percentage of Participants With Local and Systemic Reaction to Injections | Local reaction: Injection 2 | 16.16 percentage of participants |
| Engerix-B | Percentage of Participants With Local and Systemic Reaction to Injections | Local reaction: Injection 3 | 13.84 percentage of participants |