Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

Phase 3 Completed 8374 enrolled Dynavax Technologies Corporation

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2014-04
Primary completion: 2015-10
Completion: 2015-10

Outcome

Met primary endpoint

paper which met the prospectively-defined criteria for noninferiority and statistical significance. PMID 29289383 ↗

Publications

Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.
Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.

Drugs

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

Indications

No indication recorded.