Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Phase 3

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
HEPLISAV	HEPLISAV	0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and placebo (saline injection) at Week 24, followed by a 52-week safety follow-up from the last active dose of HEPLISAV.
Engerix-B	Engerix-B	1.0 mL Engerix-B (20 mcg HBsAg adsorbed on 500 mcg of aluminum hydroxide) administered intramuscularly in the deltoid muscle at Weeks 0, 4, and 24, followed by a 32-week safety follow-up from the last dose of Engerix-B.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Locations (3): Clinical Research Advantage, Inc.
🇺🇸
Plano, Texas, United States
Clinical Research Advantage, Inc
🇺🇸
Evansville, Indiana, United States
Radiant Research
🇺🇸
Murray, Utah, United States