Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease Patients

• Conditions: Prevention of hepatitis B virus (HBV) infection; MedDRA version: 14.0Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2009-015877-11-DE
• Lead Sponsor: Dynavax Technologies Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-11
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

A subject must meet all of the following inclusion criteria to participate in the study:

1. be 18 to 75 years of age;

2. has loss of renal function as defined by a GFR = 45 mL/min/1.73 m2;

3. be clinically stable in the opinion of the investigator;

4. be serum negative for HBsAg, anti-HBsAg, anti-HBcAg, HCV, and HIV;

5. 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;

6. is not scheduled to undergo a kidney transplant in the next 12 months;

7. be able and willing to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 282
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 237

Exclusion Criteria

A subject who meets any 1 of the following exclusion criteria is not permitted to participate in the study:

1. if female, is pregnant, breastfeeding, or planning a pregnancy;

2. 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, unprotected sex with known HBV/HIV positive partner;

3. has known history of autoimmune disease;

4. has previously received any hepatitis B vaccine;

5. has a history of sensitivity to any component of study vaccines;

6. 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;

7. 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;

8. has uncontrolled diabetes or hypertension;

9. is unwilling or unable to comply with all the requirements of the protocol;

10. 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;

11. 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-stimulating factor (G/GM-CSF)

– any other investigational medicinal agent

• At any time: an injection of DNA plasmids or oligonucleotides.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified