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

NCT00985426 | Completed Phase 3 Results DMC

• 2 other identifiers: DV2-HBV-172009-015877-11
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 28

Secondary Outcomes (5)

• Reactogenicity as Measured by the Percentage of Participants With Local and Systemic Post-injection Reactions Within 7 Days After Each Injection Visit

  7 days after each injection visit (Weeks 0, 4, 8, and 24)

• Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response at Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52

  Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52

• 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

  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

  Weeks 4, 8, 12, 18, 24, 28, 36, 44, and 52

• SPR of Participants With Type 2 Diabetes Mellitus at Week 28

  Week 28

Study Arms (2)

HEPLISAV-B

EXPERIMENTAL

0.5 mL HEPLISAV-B and 0.5 mL Placebo

Biological: HEPLISAV-B; Other: Placebo

Engerix-B

ACTIVE COMPARATOR

2.0 mL Engerix-B

Biological: Engerix-B

Interventions

HEPLISAV-B BIOLOGICAL

Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24

Also known as: Hepatitis B vaccine (recombinant), adjuvanted

HEPLISAV-B

Engerix-B BIOLOGICAL

Intramuscular (IM) injections at Weeks 0, 4, 8, and 24

Also known as: Hepatitis B vaccine (recombinant)

Engerix-B

Placebo OTHER

Placebo(saline) intramuscular (IM) injection at Week 8

Also known as: Saline

HEPLISAV-B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• days: intravenous iron
• days: any inactivated virus vaccine
• days:
• any live virus vaccine

Sponsors & Collaborators

• Dynavax Technologies Corporation: lead

Study Sites (1)

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 23727422 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Hepatitis B; Hepatitis

Interventions

Heplisav-B; Hepatitis B Vaccines; Engerix-B; Sodium Chloride

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Robert Janssen MD \ VP & Chief Medical Officer
• Organization: Dynavax Technologies, Inc.

rjanssen@dynavax.com

510-665-0414

Study Officials

• Robert Janssen, MD

  Dynavax Technologies Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 28, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 19, 2021
• Results First Posted: December 16, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)