Healthy
Conditions
Keywords
HBV vaccine, HEPLISAV-B, Hepatitis B vaccine, Hepatitis B, Hepatitis, Hepatitis B virus (HBV), Prevention and Control, Healthy, Healthy volunteers
Brief summary
The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.
Interventions
BIOLOGICALEngerix-B
Intramuscular injections at Week 0, Week 4, and Week 24
BIOLOGICALHEPLISAV
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at 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
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
A subject must meet all of the following criteria to be eligible for the trial: Inclusion Criteria: * Be 18-70 years of age, inclusive * Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study * If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28. * Able and willing to provide informed consent A subject with any one of the following criteria is not eligible for the trial:
Exclusion criteria
* Previous receipt of any hepatitis B vaccine * History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV * History of autoimmune disorder * History of sensitivity to any component of study vaccines * Has received the following prior to the first injection: 1. Within 28 days: * Any vaccine * Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication * Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) * Any other investigational medicinal agent 2. Within 90 days: Blood products or immunoglobulin 3. At any time: An injection of DNA plasmids or oligonucleotide * If female: Pregnant, nursing, or planning to become pregnant during the trial * 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 * Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | Week 56 | 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. |
| Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response | Week 28 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEPLISAV 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 | 5,587 |
| Engerix-B 1.0 mL Engerix-B
Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24 | 2,781 |
| Total | 8,368 |
Baseline characteristics
| Characteristic | HEPLISAV | Engerix-B | Total |
|---|---|---|---|
| Age, Customized Age ≥ 18 to ≤ 39 years | 1132 Participants | 561 Participants | 1693 Participants |
| Age, Customized Age ≥ 40 years | 4455 Participants | 2220 Participants | 6675 Participants |
| Region of Enrollment United States | 5587 Participants | 2781 Participants | 8368 Participants |
| Sex: Female, Male Female | 2743 Participants | 1390 Participants | 4133 Participants |
| Sex: Female, Male Male | 2844 Participants | 1391 Participants | 4235 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1,097 / 5,587 | 549 / 2,781 |
| serious Total, serious adverse events | 345 / 5,587 | 148 / 2,781 |
Outcome results
Primary
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
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
Population: Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HEPLISAV | Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | New-onset Immune-mediated Adverse Events | 0.1 percentage of participants |
| HEPLISAV | Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | Medically-attended Adverse Events | 46.0 percentage of participants |
| HEPLISAV | Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | Serious Adverse Events | 6.2 percentage of participants |
| Engerix-B | Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | Serious Adverse Events | 5.3 percentage of participants |
| Engerix-B | Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | New-onset Immune-mediated Adverse Events | 0.04 percentage of participants |
| Engerix-B | Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest | Medically-attended Adverse Events | 46.2 percentage of participants |
Primary
Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| HEPLISAV | Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response | 90.0 Percentage of participants |
| Engerix-B | Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response | 65.1 Percentage of participants |