Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

Phase 3 Completed 2452 enrolled Dynavax Technologies Corporation

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Timeline

Start: 2010-02
Primary completion: 2011-01
Completion: 2011-05

Publications

Heyward WL, Kyle M, Blumenau J, Davis M, Reisinger K, Kabongo ML, Bennett S, Janssen RS, Namini H, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age. Vaccine. 2013 Nov 4;31(46):5300-5. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Engerix-B	Vaccine	1 ml	Intramuscular
Subject	HEPLISAV	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.