Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients

Phase 3 Completed 521 enrolled Dynavax Technologies Corporation

RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.

Timeline

Start: 2009-09
Primary completion: 2012-01
Completion: 2012-01

Outcome

Met primary endpoint

registry analysis (superiority test); HEPLISAV-B vs Engerix-B; SPR Difference (%) 8 (95% CI 1.7 to 14.3) NCT00985426 ↗

paper the HBsAg-1018 group (89.9%) met criteria for noninferiority and superiority to the SPR in the HBsAg-Eng group (81.8%). PMID 23727422 ↗

Publications

Janssen RS, Mangoo-Karim R, Pergola PE, Girndt M, Namini H, Rahman S, Bennett SR, Heyward WL, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine. 2013 Nov 4;31(46):5306-13. doi: 10.1016/j.vaccine.2013.05.067. Epub 2013 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Engerix-B	Vaccine	2 ml	Intramuscular
Subject	HEPLISAV-B	Vaccine	0.5 ml	Intramuscular