Clinical trial NCT02117934: Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: HBV vaccine
HEPLISAV-B
Hepatitis B vaccine
Hepatitis B
Hepatitis
Hepatitis B virus (HBV)
Prevention and Control
Healthy
Healthy volunteers
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 8374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest
timeFrame: Week 56
measure: Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response
timeFrame: Week 28
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Advantage, Inc.
state: Alabama
city: Chandler
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Glendale
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Tucson
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Vista
country: United States
facility: Clinical Research Advantage, Inc.
state: California
city: Centennial
country: United States
facility: Clinical Research Advantage, Inc.
state: Colorado
city: Colorado Springs
country: United States
facility: Clinical Research Advantage, Inc.
state: Colorado
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Evansville
country: United States
facility: Clinical Research Advantage, Inc
state: Indiana
city: Council Bluffs
country: United States
facility: Clinical Research Advantage, Inc.
state: Iowa
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Saint Louis
country: United States
facility: Radiant Research
state: Missouri
city: Elkhorn
country: United States
facility: Clinical Research Advantage, Inc.
state: Nebraska
city: Fremont
country: United States
facility: Clinical Research Advantage, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Clinical Research Advantage, Inc.
state: Nebraska
city: Henderson
country: United States
facility: Clinical Research Advantage, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Advantage, Inc.
state: Nevada
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Anderson
country: United States
facility: Clinical Research Advantage, Inc.
state: South Carolina
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Plano
country: United States
facility: Clinical Research Advantage, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Murray
country: United States
facility: Radiant Research
state: Utah
Study officials:
affiliation: Dynavax Technologies Corporation
name: Robert Janssen, MD
role: STUDY_DIRECTOR
References:
citation: Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.
citation: Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.