NCT01282762

Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease

An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ Compared With Engerix-B® in Adults With Chronic Kidney Disease Who Have Previously Received At Least One Hepatitis B Vaccine Series

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 147 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in a cohort of chronic kidney disease (CKD) patients over time.

Detailed description

An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ compared with Engerix-B® in Adults with Chronic Kidney Disease who Have Previously Received At Least One Hepatitis B Vaccine Series

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	HEPLISAV	0.5 mL administered intramuscularly (IM) at Week 0, Week 4 and Week 24. HEPLISAV booster injection = one dose of 0.5 mL volume when needed.
BIOLOGICAL	Engerix-B	2.0 mL administered intramuscularly (IM) at Week 0, Week 4, Week 8 and Week 24. Engerix-B booster injection = one dose of 2.0 mL volume when needed

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-01-25
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States