Chronic Kidney DiseaseNCT01282762
Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Dynavax Technologies Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- HEPLISAV and Engerix-B
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with Chronic Kidney Disease previously enrolled in the Dynavax clinical studies DV2-HBV-17 and DV2-HBV-18
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507
About this study
Official 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
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.
Read the detailed description
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
- Conditions
- Chronic Kidney Disease
- Being tested
- HEPLISAV, Engerix-B
- Keywords
- Prevention of Hepatitis B infection., End Stage Renal Disease, Hepatitis B vaccination, Hepatitis B virus (HBV)
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEPLISAVBiological
Also called Hepatitis B vaccine (recombinant), adjuvanted
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.
Engerix-BBiological
Also called Hepatitis B vaccine (recombinant)
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Measured: 6 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Measured: 12 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Measured: 24 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Measured: 36 months
To evaluate the durability of seroprotection induced by HEPLISAV and Engerix-B as measured by SPR (anti-HBsAg> 10 mIU/mL
Measured: 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.
Measured: Baseline and 6,12, 24, 36 and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282762
- Sponsor's protocol ID
- DV2-HBV-19
- Status last verified
- Mar 2019
- First submitted
- 20 Jan 2011
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: No Changes to status a/o 3/2017
Publications
Girndt M, Houser P, Manllo-Karim R, Ervin JE, Charytan C, Chow S, Symonian-Silver M, Lehrner L, Linfert D, Shemin D, Michelsen A, Xie F, Janssen RS. Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease. Vaccine. 2023 May 11;41(20):3224-3232. doi: 10.1016/j.vaccine.2023.04.028. Epub 2023 Apr 19.
PubMed 37085451
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01282762
- Acronym / sponsor ID
- DV2-HBV-19
- Conditions
- Chronic Kidney Disease
- Keywords
- Prevention of Hepatitis B infection., End Stage Renal Disease, Hepatitis B vaccination, Hepatitis B virus (HBV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Dynavax Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Chronic Kidney Disease previously enrolled in the Dynavax clinical studies DV2-HBV-17 and DV2-HBV-18
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEPLISAVAlso: Hepatitis B vaccine (recombinant), adjuvanted0.5 mL administered intramuscularly (IM) at Week 0, Week 4 and Week 24. HEPLISAV booster injection = one dose of 0.5 mL volume when needed. | Biological | – |
| Engerix-BAlso: Hepatitis B vaccine (recombinant)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 | Biological | – |
Primary outcome
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
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
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
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Derived from this study: PubMed 37085451Girndt M, Houser P, Manllo-Karim R, Ervin JE, Charytan C, Chow S, Symonian-Silver M, Lehrner L, Linfert D, Shemin D, Michelsen A, Xie F, Janssen RS. Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease. Vaccine. 2023 May 11;41(20):3224-3232. doi: 10.1016/j.vaccine.2023.04.028. Epub 2023 Apr 19.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. No Changes to status a/o 3/2017
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Dynavax Technologies Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.