Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
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| ClinicalTrials.gov Identifier: NCT02117934 |
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Recruitment Status :
Completed
First Posted : April 21, 2014
Results First Posted : January 10, 2018
Last Update Posted : March 20, 2019
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Sponsor:
Dynavax Technologies Corporation
Information provided by (Responsible Party):
Dynavax Technologies Corporation
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Biological: HEPLISAV Biological: Engerix-B | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 8374 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 Start Date : | April 2014 |
| Actual Primary Completion Date : | October 2015 |
| Actual Study Completion Date : | October 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Biological: HEPLISAV
Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
Other Names:
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Active Comparator: 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.
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Biological: Engerix-B
Intramuscular injections at Week 0, Week 4, and Week 24
Other Name: Hepatitis B vaccine (recombinant) |
Primary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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Has received the following prior to the first injection:
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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
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- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117934
Locations
Show 40 study locations
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
| Study Director: | Robert Janssen, MD | Dynavax Technologies Corporation |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dynavax Technologies Corporation |
| ClinicalTrials.gov Identifier: | NCT02117934 |
| Other Study ID Numbers: |
DV2-HBV-23 |
| First Posted: | April 21, 2014 Key Record Dates |
| Results First Posted: | January 10, 2018 |
| Last Update Posted: | March 20, 2019 |
| Last Verified: | March 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Dynavax Technologies Corporation:
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HBV vaccine HEPLISAV-B Hepatitis B vaccine Hepatitis B Hepatitis |
Hepatitis B virus (HBV) Prevention and Control Healthy Healthy volunteers |
Additional relevant MeSH terms:
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Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Blood-Borne Infections Communicable Diseases Infections |
Hepadnaviridae Infections DNA Virus Infections Virus Diseases Hepatitis, Viral, Human Vaccines Immunologic Factors Physiological Effects of Drugs |