Chronic Kidney Disease
Conditions
Keywords
chronic kidney disease, kidney failure, kidney failure,chronic, chronic kidney failure, hepatitis B virus (HBV) vaccine, hepatitis B vaccine, hepatitis B, hepatitis, HBV, prevention and control, dialysis
Brief summary
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
Interventions
BIOLOGICALHEPLISAV-B
Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24
BIOLOGICALEngerix-B
Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
OTHERPlacebo
Placebo(saline) intramuscular (IM) injection at Week 8
Sponsors
Dynavax Technologies Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* be 18 to 75 years of age; * progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²; * be clinically stable in the opinion of the investigator; * be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV); * if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection; * is not scheduled to undergo a kidney transplant in the next 12 months; * be able and willing to provide informed consent.
Exclusion criteria
* if female, 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, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner; * has known history of autoimmune disease; * has previously received any HBV vaccine; * has a history of sensitivity to any component of study vaccines; * has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results; * is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin; * has uncontrolled diabetes or hypertension; * is unwilling or unable to comply with all the requirements of the protocol; * has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period; * has received the following prior to the first injection: * 3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis) * 7 days: intravenous iron * 21 days: any inactivated virus vaccine * 28 days: * any live virus vaccine * systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids * granulocyte or granulocyte-macrophage colony-simulating factor (G/GM-CSF), any other investigational medicinal agent * At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response | Week 28 | SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit | 7 days after each injection visit (Weeks 0, 4, 8, and 24) | Local reactions include redness greater than or equal to 25 mm, swelling greater than or equal to 25 mm, and pain. Systemic reactions include malaise, headache, myalgia, fatigue, and fever (temperature greater than or equal to 38ºC). This table presents post-injection reactions at active injection visits only. Post-injection reactions after the third (placebo) injection visit in the HEPLISAV-B group are not included. |
| Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B. |
| Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | — |
| Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | — |
| SPR of Participants With Type 2 Diabetes Mellitus at Week 28 | Week 28 | SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEPLISAV-B Participants randomized to the HEPLISAV-B group received 0.5 mL HEPLISAV-B and 0.5 mL Placebo (saline) via intramuscular (IM) injections at Weeks 0, 4, and 24.
Participants also received two 0.5-mL IM injections of Placebo (saline) at Week 8. | 254 |
| Engerix-B Participants randomized to the Engerix-B group received two 1.0-mL IM injections of Engerix-B at Weeks 0, 4, 8, and 24. | 262 |
| Total | 516 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 7 | 3 |
| Overall Study | Lack of seroprotection at protocol-specified timepoints | 11 | 11 |
| Overall Study | Lost to Follow-up | 8 | 10 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Subject Non-Compliance | 3 | 3 |
| Overall Study | Withdrawal by Subject | 12 | 16 |
Baseline characteristics
| Characteristic | HEPLISAV-B | Engerix-B | Total |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 9.1 | 61.3 years STANDARD_DEVIATION 9.7 | 61.3 years STANDARD_DEVIATION 9.4 |
| Age, Customized Age Strata 18 to 39 years | 3 Participants | 11 Participants | 14 Participants |
| Age, Customized Age Strata 40 to 55 years | 58 Participants | 52 Participants | 110 Participants |
| Age, Customized Age Strata 56 to 75 years | 193 Participants | 199 Participants | 392 Participants |
| Body Mass Index | 34.05 kg/m2 STANDARD_DEVIATION 8.45 | 32.15 kg/m2 STANDARD_DEVIATION 6.94 | 33.09 kg/m2 STANDARD_DEVIATION 7.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 65 Participants | 71 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants | 191 Participants | 380 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Glomerular Filtration Rate (GFR) at Screening GFR ≤ 15 mL/min/1.73 m2 | 39 Participants | 55 Participants | 94 Participants |
| Glomerular Filtration Rate (GFR) at Screening GFR 16 - 30 mL/min/1.73 m2 | 99 Participants | 96 Participants | 195 Participants |
| Glomerular Filtration Rate (GFR) at Screening GFR ≥ 31 mL/min/1.73 m2 | 116 Participants | 111 Participants | 227 Participants |
| History of Type 2 Diabetes Mellitus | 173 Participants | 161 Participants | 334 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 47 Participants | 91 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) White | 204 Participants | 203 Participants | 407 Participants |
| Screening Creatinine | 2.66 mg/dL STANDARD_DEVIATION 1.42 | 2.82 mg/dL STANDARD_DEVIATION 1.64 | 2.74 mg/dL STANDARD_DEVIATION 1.53 |
| Sex: Female, Male Female | 94 Participants | 104 Participants | 198 Participants |
| Sex: Female, Male Male | 160 Participants | 158 Participants | 318 Participants |
| Smoking status No | 220 Participants | 219 Participants | 439 Participants |
| Smoking status Yes | 34 Participants | 43 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 254 | 3 / 262 |
| other Total, other adverse events | 140 / 254 | 146 / 262 |
| serious Total, serious adverse events | 68 / 254 | 76 / 262 |
Outcome results
Primary
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B.
Time frame: Week 28
Population: Modified Intent-to-Treat (mITT) population comprises all randomized participants who received at least 1 study injection and had at least 1 post-injection immunogenicity evaluation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response | 204 Participants |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response | 198 Participants |
Comparison: Two-sided 95% confidence intervals (CIs) of the difference in seroprotection rates (SPR) between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.95% CI: [1.7, 14.3]
Comparison: Two-sided 95% CIs of the difference in SPR between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.95% CI: [1.7, 14.3]
Secondary
Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Time frame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Population: Modified Intent-to-Treat (mITT) population comprises all randomized participants who received at least 1 study injection and had at least 1 post-injection immunogenicity evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 8 | 19.5 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 28 | 73.6 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 18 | 38.6 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 36 | 68.9 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 12 | 27.3 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 44 | 67.9 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 24 | 45.1 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 52 | 66.8 % participants |
| HEPLISAV-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 4 | 3.6 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 52 | 49.1 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 4 | 2.7 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 8 | 7 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 12 | 22.2 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 18 | 25.9 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 24 | 28.5 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 28 | 63.2 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 36 | 59 % participants |
| Engerix-B | Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 44 | 54.5 % participants |
Secondary
Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit
Local reactions include redness greater than or equal to 25 mm, swelling greater than or equal to 25 mm, and pain. Systemic reactions include malaise, headache, myalgia, fatigue, and fever (temperature greater than or equal to 38ºC). This table presents post-injection reactions at active injection visits only. Post-injection reactions after the third (placebo) injection visit in the HEPLISAV-B group are not included.
Time frame: 7 days after each injection visit (Weeks 0, 4, 8, and 24)
Population: Safety population includes randomized participants who received at least 1 study injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HEPLISAV-B | Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit | Local reactions | 73 Participants |
| HEPLISAV-B | Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit | Systemic reactions | 85 Participants |
| Engerix-B | Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit | Local reactions | 90 Participants |
| Engerix-B | Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit | Systemic reactions | 91 Participants |
Secondary
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B.
Time frame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Population: Modified Intent-to-Treat (mITT) population comprises all randomized participants who received at least 1 study injection and had at least 1 post-injection immunogenicity evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 8 | 48.1 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 28 | 89.9 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 18 | 73.7 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 36 | 86.9 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 12 | 65.1 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 44 | 83.9 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 24 | 78.7 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 52 | 84.3 percentage of participants (SPR) |
| HEPLISAV-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 4 | 5.7 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 52 | 77.3 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 4 | 6.2 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 8 | 20.2 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 12 | 50.8 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 18 | 59.5 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 24 | 62.2 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 28 | 81.8 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 36 | 80.3 percentage of participants (SPR) |
| Engerix-B | Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 44 | 78.6 percentage of participants (SPR) |
Secondary
Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Time frame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Population: Modified Intent-to-Treat (mITT) population comprises all randomized participants who received at least 1 study injection and had at least 1 post-injection immunogenicity evaluation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 8 | 8.1 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 28 | 587.1 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 18 | 33 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 36 | 302.3 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 12 | 16.5 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 44 | 214.5 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 24 | 44.3 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 52 | 170.8 mIU/mL |
| HEPLISAV-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 4 | .4 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 52 | 51 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 4 | .3 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 8 | .9 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 12 | 7.2 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 18 | 12 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 24 | 15.1 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 28 | 156.5 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 36 | 104.2 mIU/mL |
| Engerix-B | Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52 | Week 44 | 71.2 mIU/mL |
Secondary
SPR of Participants With Type 2 Diabetes Mellitus at Week 28
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B.
Time frame: Week 28
Population: Modified Intent-to-Treat (mITT) population comprises all randomized participants who received at least 1 study injection and had at least 1 post-injection immunogenicity evaluation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEPLISAV-B | SPR of Participants With Type 2 Diabetes Mellitus at Week 28 | 137 Participants |
| Engerix-B | SPR of Participants With Type 2 Diabetes Mellitus at Week 28 | 115 Participants |
Comparison: Two-sided 95% CIs of the difference in SPRs between the HEPLISAV group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.95% CI: [4.4, 21.2]