Phase 3
N=8,374
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02117934 ↗Enrolled (actual)
8,374
Serious AEs
5.9%
Results posted
Jan 2018
Primary outcome: Primary: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest — 0.1; 0.04; 46.0; 46.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HEPLISAV (Biological); Engerix-B (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dynavax Technologies Corporation
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest |
0.1; 0.04; 46.0; 46.2; 6.2; 5.3 | — |
| PRIMARY Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response |
90.0; 65.1 | — |
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:
- 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
Data sourced from ClinicalTrials.gov (NCT02117934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.