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

Healthy Clinical Trial

Official title:

A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117934
• Other study ID #: DV2-HBV-23
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 8374
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hepatitis B

Intervention

Biological:
• HEPLISAV
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
• Engerix-B
Intramuscular injections at Week 0, Week 4, and Week 24

Locations

Country	Name	City	State
United States	Radiant Research	Akron	Ohio
United States	Clinical Research Advantage, Inc.	Anderson	South Carolina
United States	Radiant Research	Anderson	South Carolina
United States	Radiant Research	Atlanta	Georgia
United States	Clinical Research Advantage, Inc.	Birmingham	Alabama
United States	Clinical Research Advantage, Inc.	Centennial	Colorado
United States	Clinical Research Advantage, Inc.	Chandler	Arizona
United States	Radiant Research	Chandler	Arizona
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Cincinnati	Ohio
United States	Clinical Research Advantage, Inc.	Colorado Springs	Colorado
United States	Radiant Research	Columbus	Ohio
United States	Clinical Research Advantage, Inc.	Council Bluffs	Iowa
United States	Radiant Research	Dallas	Texas
United States	Radiant Research	Denver	Colorado
United States	Radiant Research	Edina	Minnesota
United States	Clinical Research Advantage, Inc.	Elkhorn	Nebraska
United States	Clinical Research Advantage, Inc	Evansville	Indiana
United States	Clinical Research Advantage, Inc.	Fremont	Nebraska
United States	Clinical Research Advantage, Inc.	Glendale	Arizona
United States	Radiant Research	Greer	South Carolina
United States	Clinical Research Advantage, Inc.	Henderson	Nevada
United States	Clinical Research Advantage, Inc.	Las Vegas	Nevada
United States	Clinical Research Advantage, Inc.	Mesa	Arizona
United States	Clinical Research Advantage, Inc.	Mesa	Arizona
United States	Radiant Research	Murray	Utah
United States	Clinical Research Advantage, Inc.	Omaha	Nebraska
United States	Clinical Research Advantage, Inc.	Phoenix	Arizona
United States	Clinical Research Advantage, Inc.	Phoenix	Arizona
United States	Clinical Research Advantage, Inc.	Phoenix	Arizona
United States	Radiant Research	Pinellas Park	Florida
United States	Clinical Research Advantage, Inc.	Plano	Texas
United States	Radiant Research	Saint Louis	Missouri
United States	Radiant Research	San Antonio	Texas
United States	Radiant Research	Santa Rosa	California
United States	Radiant Research	Scottsdale	Arizona
United States	Clinical Research Advantage, Inc.	Tempe	Arizona
United States	Clinical Research Advantage, Inc.	Tucson	Arizona
United States	Radiant Research	Tucson	Arizona
United States	Clinical Research Advantage, Inc.	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 56
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	Week 28