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

Dynavax Technologies Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Biological: HEPLISAV-B; Biological: Engerix-B; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985426

DV2-HBV-17

2009-015877-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 521 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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521 participants in 2 patient groups

HEPLISAV-B

Experimental group

Description:

0.5 mL HEPLISAV-B and 0.5 mL Placebo

Treatment:

Other: Placebo

Biological: HEPLISAV-B

Engerix-B

Active Comparator group

Description:

2.0 mL Engerix-B

Treatment:

Biological: Engerix-B