Clinical trial NCT00985426: Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
Official title: An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV-B® to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
kidney failure
kidney failure,chronic
chronic kidney failure
hepatitis B virus (HBV) vaccine
hepatitis B vaccine
hepatitis B
hepatitis
HBV
prevention and control
dialysis
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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 than squamous or basal cell carcinoma of the skin;
* has uncontrolled diabetes or hypertension;
* is unwilling or unable to comply with all the requirements of the protocol;
* has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
* has received the following prior to the first injection:
* 3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis)
* 7 days: intravenous iron
* 21 days: any inactivated virus vaccine
* 28 days:
* any live virus vaccine
* systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
* granulocyte or granulocyte-macrophage colony-simulating factor (G/GM-CSF), any other investigational medicinal agent
* At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide

Primary outcomes:
measure: Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
timeFrame: Week 28
Secondary outcomes:
measure: Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit
timeFrame: 7 days after each injection visit (Weeks 0, 4, 8, and 24)
measure: Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
timeFrame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
measure: Percentage of Participants With Anti-HBsAg Greater Than or Equal to 100 mIU/mL at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
timeFrame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
measure: Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
timeFrame: Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
measure: SPR of Participants With Type 2 Diabetes Mellitus at Week 28
timeFrame: Week 28
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
affiliation: Dynavax Technologies Corporation
name: Robert Janssen, MD
role: STUDY_DIRECTOR
References:
citation: 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.