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Completed

NCT Number: NCT01282762

Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease

The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in a cohort of chronic kidney disease (CKD) patients over time.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

About this study

An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ compared with Engerix-B® in Adults with Chronic Kidney Disease who Have Previously Received At Least One Hepatitis B Vaccine Series

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • enrolled and completed HEPLISAV or Engerix-B treatment in: DV2-HBV-17 or DV2-HBV-18 and had anti-HBsAg ≥ 10 mIU/mL prior to or during DV2-HBV-18
  • previously received a complete primary hepatitis B vaccine series in DV2-HBV-17 or prior to enrollment in DV2-HBV-18
  • be otherwise clinically stable in the opinion of the investigator
  • be able and willing to provide informed consent

Exclusion criteria

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

  • previously enrolled in DV2-HBV-18 and never obtained anti-HBsAg ≥ 10 mIU/mL
  • received hepatitis B vaccine off-study after enrolling in DV2-HBV-17 or DV2-HBV-18
  • has known history of autoimmune disease
  • is unwilling or unable to comply with all the requirements of the protocol

Treatment and study plan

HEPLISAV

Biological

0.5 mL administered intramuscularly (IM) at Week 0, Week 4 and Week 24.

HEPLISAV booster injection = one dose of 0.5 mL volume when needed.

Other names: Hepatitis B vaccine (recombinant), adjuvanted

Engerix-B

Biological

2.0 mL administered intramuscularly (IM) at Week 0, Week 4, Week 8 and Week 24.

Engerix-B booster injection = one dose of 2.0 mL volume when needed

Other names: Hepatitis B vaccine (recombinant)

Primary outcomes

  1. To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by seroprotection rate (SPR) (anti-HBsAg> 10 milli-international unit (mIU)/mL

    Time frame: Baseline

  2. To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL

    Time frame: 6 months

  3. To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL

    Time frame: 12 months

  4. To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL

    Time frame: 24 months

  5. To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL

    Time frame: 36 months

  6. To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL

    Time frame: 48 months

Secondary outcomes

  1. To evaluate the safety of HEPLISAV and Engerix-B in CKD subjects who previously received at least one hepatitis B vaccine series.

    Time frame: Baseline and 6,12, 24, 36 and 48 months

Sponsors and collaborators

Lead sponsor

Dynavax Technologies Corporation

Industry

Registry information

Official study title

An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ Compared With Engerix-B® in Adults With Chronic Kidney Disease Who Have Previously Received At Least One Hepatitis B Vaccine Series

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2011
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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