A Phase III Safety and Efficacy Study to Compare Immune Responses following Injection with Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®

• Conditions: Prevention of Hepatitis B Virus (HBV) infection.; MedDRA version: 9.1Level: LLTClassification code 10054181Term: Hepatitis B immunization

• Registration Number: EUCTR2006-006743-31-DE
• Lead Sponsor: Dynavax Technologies Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

Subjects who: are at least 11 and up to 55 years of age (at least 18 and up to 55 years of age for the US and Germany); provide informed consent and are available for the duration of the study; and are serum negative for HBsAg, anti-HBsAg antibody, anti-Hepatitis B core antigen antibody (anti-HBcAg antibody). If female and of childbearing potential, subjects must have been consistently using effective birth control for the 28 days prior to the study entry and be willing to consistently use a highly effective method of birth control as specified in the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who: are female and are pregnant, breastfeeding or planning a pregnancy during the study period; have a history of HBV infection; have a history of one or more injections with a HBV vaccine; have a clinically debilitating acute or chronic illness; have a history of or laboratory evidence of diseases of autoimmune origin; are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV); have received blood products or immunoglobulin in the last 3 months; have ever received injection with deoxyribonucleic acid (DNA) plasmids or oligonucleotides; have received systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication in the last 4 weeks; have been administered granulocyte-macrophage colony-stimulating factor (G/GM-CSF) within the last 4 weeks; have received any vaccines 4 weeks prior to study entry or are planning for elective vaccination that will occur either during the week before or 2 weeks after any study injection; has a history of sensitivity to any component of the study vaccines; are unwilling or unable to comply with all the requirements of the protocol; have received any other investigational medicinal agent 4 weeks prior to this study; or have current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified