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.
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
Study Type
OBSERVATIONAL
Enrollment
147
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.
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
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by seroprotection rate (SPR) (anti-HBsAg> 10 milli-international unit (mIU)/mL
Time frame: Baseline
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Time frame: 6 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Time frame: 12 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Time frame: 24 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Time frame: 36 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Time frame: 48 months
To evaluate the safety of HEPLISAV and Engerix-B in CKD subjects who previously received at least one hepatitis B vaccine series.
Time frame: Baseline and 6,12, 24, 36 and 48 months
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