Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) … (NCT00985426) | Clinical Trial Compass
CompletedPhase 3
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
United States521 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* be 18 to 75 years of age;
* progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²;
* be clinically stable in the opinion of the investigator;
* be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
* if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection;
* is not scheduled to undergo a kidney transplant in the next 12 months;
* be able and willing to provide informed consent.
Exclusion Criteria:
* if female, is pregnant, breastfeeding, or planning a pregnancy;
* has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner;
* has known history of autoimmune disease;
* has previously received any HBV vaccine;
* has a history of sensitivity to any component of study vaccines;
* has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results;
* is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other th…
What they're measuring
1
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response