Hepatitis B
Conditions
Keywords
Hepatitis B vaccine, HBV vaccine, Hepatitis B, Hepatitis, HBV, Vaccine, 1018, HBsAg
Brief summary
The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
Detailed description
This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity. Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.
Interventions
BIOLOGICALHEPLISAV
Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
Sponsors
Dynavax Technologies Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to give written informed consent * Women of childbearing potential must be willing to consistently use a highly effective method of birth control
Exclusion criteria
* Women who are pregnant or breastfeeding * Any previous HBV infection * Previous vaccination (1 or more doses) with any HBV vaccine * Any previous autoimmune diseases * Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) * Received any blood products or antibodies within 3 months prior to study entry * Ever received an injection with DNA plasmids or oligonucleotides * Received any vaccines within 4 weeks prior to study entry * Received any other investigational medicinal agent within 4 weeks prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local and Systemic Post-injection Reaction Rates | Within 7 days post-injection for post-injection reactions at Week 0 and Week 4 | Local and Systemic post-injection reactions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28. | Weeks 4, 8, 12 and 28 | Seroprotective Immune Response |
| Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 | Weeks 4, 8, 12, and 28 | Measurement of Serum GMC |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEPLISAV 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) HEPLISAV: Intramuscular (IM) injections at Week 0 and Week 4 | 207 |
| Total | 207 |
Baseline characteristics
| Characteristic | HEPLISAV |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 207 Participants |
| Age, Continuous | 43.0 years STANDARD_DEVIATION 8.36 |
| Region of Enrollment United States | 207 Participants |
| Sex: Female, Male Female | 133 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 59 / 207 |
| serious Total, serious adverse events | 2 / 207 |
Outcome results
Primary
Percentage of Participants With Local and Systemic Post-injection Reaction Rates
Local and Systemic post-injection reactions.
Time frame: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
Population: Safety Population: Subjects who received at least 1 study injection and had any post-baseline safety data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HEPLISAV (Week 0) | Percentage of Participants With Local and Systemic Post-injection Reaction Rates | Local Reaction: Injection | 38.2 percentage of subjects |
| HEPLISAV (Week 0) | Percentage of Participants With Local and Systemic Post-injection Reaction Rates | Systemic Reaction: Injection | 37.2 percentage of subjects |
| HEPLISAV (Week 4) | Percentage of Participants With Local and Systemic Post-injection Reaction Rates | Local Reaction: Injection | 37.9 percentage of subjects |
| HEPLISAV (Week 4) | Percentage of Participants With Local and Systemic Post-injection Reaction Rates | Systemic Reaction: Injection | 33.0 percentage of subjects |
Secondary
Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.
Seroprotective Immune Response
Time frame: Weeks 4, 8, 12 and 28
Population: Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HEPLISAV (Week 0) | Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28. | 32.7 percentage of subjects |
| HEPLISAV (Week 4) | Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28. | 84.9 percentage of subjects |
| HEPLISAV (Week 12) | Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28. | 93.4 percentage of subjects |
| HEPLISAV (Week 28) | Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28. | 95.4 percentage of subjects |
Secondary
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28
Measurement of Serum GMC
Time frame: Weeks 4, 8, 12, and 28
Population: Intent-to-treat population: Enrolled subjects who received at least 1 study injection irrespective of available immune response data.~Note: Number Analyzed is the number of subjects with nonmissing concentrations at that visit.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HEPLISAV (Week 0) | Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 | Week 4 | 11.5 mIU/mL |
| HEPLISAV (Week 0) | Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 | Week 8 | 97.1 mIU/mL |
| HEPLISAV (Week 0) | Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 | Week 12 | 170.7 mIU/mL |
| HEPLISAV (Week 0) | Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 | Week 28 | 349.4 mIU/mL |