Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dynavax Technologies Corporation
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
A subject must meet all of the following criteria to be eligible for the trial:
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
You may not be if
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
Clareo Health | Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
