Safety and Immunogenicity Study of the… | Clinical Trial

Key information

Conditions

Healthy Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Advantage, Inc., Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

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
Within 90 days: Blood products or immunoglobulin
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

Treatment and study plan

HEPLISAV

Biological

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

Other names: Hepatitis B vaccine (recombinant), adjuvanted, HEPLISAV-B

Engerix-B

Biological

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

Other names: Hepatitis B vaccine (recombinant)

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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Dynavax Technologies Corporation

Industry

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 21, 2014
Registry last updated: Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed