NCT02117934

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

A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,374 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	HEPLISAV	Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
BIOLOGICAL	Engerix-B	Intramuscular injections at Week 0, Week 4, and Week 24

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-04-21
• Last updated: 2019-03-20
• Results posted: 2018-01-10

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study