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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT00985426
First received: September 24, 2009
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The purpose of the study is to explore the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.


Condition Intervention Phase
Chronic Kidney Disease
Biological: HEPLISAV
Biological: Engerix-B
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Proportion of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mlU)/mL) at week 28. [ Time Frame: week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall incident of post-injection reactions and adverse events in each treatment group [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]

Enrollment: 521
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HEPLISAV
0.5 mL HEPLISAV
Biological: HEPLISAV
Intramuscular (IM) injections on Weeks 0, 4, and 24; placebo (saline) injection at Week 8
Other Name: Hepatitis B vaccine (recombinant), adjuvanted
Active Comparator: Engerix-B
2.0 mL Engerix-B
Biological: Engerix-B
Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
Other Name: Hepatitis B vaccine (recombinant)

Detailed Description:

The purpose of the study is to explore the safety and Immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985426

Locations
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Sponsors and Collaborators
Dynavax Technologies Corporation
  More Information

Additional Information:
No publications provided by Dynavax Technologies Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00985426     History of Changes
Other Study ID Numbers: DV2-HBV-17, 2009-015877-11
Study First Received: September 24, 2009
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dynavax Technologies Corporation:
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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014