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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HEPLISAV-B
Engerix-B
Placebo
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Research Associates of Tidewater

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HEPLISAV-B

Engerix-B

Arm Description

0.5 mL HEPLISAV-B and 0.5 mL Placebo

2.0 mL Engerix-B

Outcomes

Primary Outcome Measures

Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B compared to that after Engerix-B.

Secondary Outcome Measures

Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit
Local reactions include redness greater than or equal to 25 mm, swelling greater than or equal to 25 mm, and pain. Systemic reactions include malaise, headache, myalgia, fatigue, and fever (temperature greater than or equal to 38ºC). This table presents post-injection reactions at active injection visits only. Post-injection reactions after the third (placebo) injection visit in the HEPLISAV-B group are not included.
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B compared to that after Engerix-B.
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
Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
SPR of Participants With Type 2 Diabetes Mellitus at Week 28
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B compared to that after Engerix-B.

Full Information

First Posted
September 24, 2009
Last Updated
April 28, 2021
Sponsor
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00985426
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEPLISAV-B
Arm Type
Experimental
Arm Description
0.5 mL HEPLISAV-B and 0.5 mL Placebo
Arm Title
Engerix-B
Arm Type
Active Comparator
Arm Description
2.0 mL Engerix-B
Intervention Type
Biological
Intervention Name(s)
HEPLISAV-B
Other Intervention Name(s)
Hepatitis B vaccine (recombinant), adjuvanted
Intervention Description
Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24
Intervention Type
Biological
Intervention Name(s)
Engerix-B
Other Intervention Name(s)
Hepatitis B vaccine (recombinant)
Intervention Description
Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Placebo(saline) intramuscular (IM) injection at Week 8
Primary Outcome Measure Information:
Title
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response
Description
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B compared to that after Engerix-B.
Time Frame
Week 28
Secondary Outcome Measure Information:
Title
Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit
Description
Local reactions include redness greater than or equal to 25 mm, swelling greater than or equal to 25 mm, and pain. Systemic reactions include malaise, headache, myalgia, fatigue, and fever (temperature greater than or equal to 38ºC). This table presents post-injection reactions at active injection visits only. Post-injection reactions after the third (placebo) injection visit in the HEPLISAV-B group are not included.
Time Frame
7 days after each injection visit (Weeks 0, 4, 8, and 24)
Title
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Description
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B compared to that after Engerix-B.
Time Frame
Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Title
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
Time Frame
Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Title
Serum Anti-HBsAg Geometric Mean Concentration (GMC) at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Time Frame
Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52
Title
SPR of Participants With Type 2 Diabetes Mellitus at Week 28
Description
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit [mIU]/mL) after HEPLISAV-B compared to that after Engerix-B.
Time Frame
Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Janssen, MD
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23727422
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.
Results Reference
derived
Links:
URL
http://www.dynavax.com/
Description
Related Info

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

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