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

Dynavax Technologies Corporation8,374 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

8,374

Conditions

Healthy

Interventions

HEPLISAVBIOLOGICAL

Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24

Engerix-BBIOLOGICAL

Intramuscular injections at Week 0, Week 4, and Week 24

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (40)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.