Peritoneal DialysisPhase 4NCT00125775
Does Extra-High Dose Hepatitis B Vaccination Confer Longer Serological Protection in Peritoneal Dialysis Patients?
A Phase 4 study testing Engerix-B in people with Peritoneal Dialysis and Renal Disease, End-Stage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Hepatitis B virus causes inflammation of the liver which is detrimental to the end-stage renal disease patients on dialysis. Hepatitis B vaccine is recommended for this high-risk population although the vaccine protection remains suboptimal and does not last long. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Renal Disease, End-Stage
- What is being tested?
- Engerix-B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2005to Dec 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- End-stage renal disease and on maintenance peritoneal dialysis
- Serologically negative for hepatitis B surface antigen (HBsAg) and antibody to hepatitis core antigen (anti-HBc)
- No history of receiving hepatitis B vaccination
- Willingness to give written informed consent and willingness to participate in and comply with the study protocol
Who cannot join
- Expected survival less than 6 months
- Those who refused vaccination
- Active malignancy
- Alcoholic liver disease
- Chronic hepatitis C and/or human immunodeficiency virus (HIV) infection
- Receiving immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital
New Territories, New Territories, SAR
About this study
Official title: Phase 4 Study of Recombinant Hepatitis B Vaccine in Peritoneal Dialysis Subjects
Hepatitis B virus causes inflammation of the liver which is detrimental to the end-stage renal disease patients on dialysis. Hepatitis B vaccine is recommended for this high-risk population although the vaccine protection remains suboptimal and does not last long.
The purpose of this study is to determine the best vaccination strategy over a 6-month period using recombinant hepatitis B vaccine (Engerix-B) in peritoneal dialysis patients. Current data show that the traditional Engerix-B vaccine dose (40 micrograms) does not always lead to protective and long-lasting hepatitis B surface antibody. The investigators, therefore, decided to compare the usual 40-micrograms with an 80-microgram dose strategy of vaccine protection.
Read the detailed description
The objective of the present randomized study is to evaluate the optimum strategy of recombinant hepatitis B vaccination in the maintenance of protective anti-HBs antibody among end-stage renal disease patients on peritoneal dialysis. This study is designed to establish whether a three-dose schedule of 80 microgram Engerix-B vaccine could maintain protective antibody response among dialysis patients. The secondary aim is to identify the effects of dosing on various subgroups of dialysis patients.
Viral hepatitis B infection remains a major health hazard for end-stage renal disease patients on dialysis. The direct costs of hepatitis B infection and long term impact on morbidity and renal transplantation are substantial. Apart from the devastating consequences of hepatitis B infection on patients on dialysis or after transplantation, infected patients are potential reservoirs for infecting other patients and haemodialysis staff. Antibody production achieved in renal patients is suboptimal; the most effective method of vaccination to prevent hepatitis B infections in end-stage renal disease subjects has hitherto been unanswered by the current literature and the latest Cochrane Collaboration review.
Given the relatively low seroconversion rate and maintenance of protective hepatitis antibody levels among end-stage renal disease patients, a treatment strategy using various doses of recombinant hepatitis B vaccine (Engerix-B) has been recently explored. In an observational study, the investigators demonstrated no statistically significant difference in response rate between patients receiving three recommended doses of Engerix-B intramuscularly (40 micrograms each dose) and those with four times the normal adult dose (80 micrograms each dose), (78% versus 100%, P = 0.23). On the other hand, according to the Kaplan-Meier estimates, 78 percent of patients in the 40 micrograms Engerix-B vaccination group and 96 percent of patients in the 80 micrograms dosing group had maintained the seroprotective levels of antibody to hepatitis B surface antigen (anti-HBs) at 12 months after initial response. This difference corresponds to an absolute risk reduction of 18 percent for losing the antibody response with a three-dose schedule of 80 micrograms Engerix-B vaccination program. In other words, the investigators estimate that giving Engerix-B 80 micrograms dose would lead to one extra end-stage renal disease subject with persistent seroprotective anti-HBs level at one year for every 5.6 patients treated (number needed to treat to benefit NNT, 5.6; 95% confidence interval, 5.4 to 5.8).
- Conditions
- Peritoneal Dialysis, Renal Disease, End-Stage
- Being tested
- Engerix-B
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix-BBiological
Engerix-B at 0, 1, 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Engerix-B 40 mcg dose Receives: Biological: Engerix-B |
| 2 | Active comparator | Engerix-B 80 mcg dose Receives: Biological: Engerix-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatitis B surface antibody anti-HBs level ≥ 10 IU/L 3 months after completion of the third dose and the persistence of protective anti-HBs 12 months after completion of the third dose of Engerix-B vaccine
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Kai Ming Chow, MRCP, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125775
- Sponsor's protocol ID
- CRE-2005.134
- Status last verified
- Jul 2009
- First submitted
- 1 Aug 2005
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Recombinant Hepatitis B Vaccine in Peritoneal Dialysis Subjects
- ClinicalTrials.gov ID
- NCT00125775
- Acronym / sponsor ID
- CRE-2005.134
- Conditions
- Peritoneal Dialysis, Renal Disease, End-Stage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Aug 2005 (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.
Hepatitis B virus causes inflammation of the liver which is detrimental to the end-stage renal disease patients on dialysis. Hepatitis B vaccine is recommended for this high-risk population although the vaccine protection remains suboptimal and does not last long.
The purpose of this study is to determine the best vaccination strategy over a 6-month period using recombinant hepatitis B vaccine (Engerix-B) in peritoneal dialysis patients. Current data show that the traditional Engerix-B vaccine dose (40 micrograms) does not always lead to protective and long-lasting hepatitis B surface antibody. The investigators, therefore, decided to compare the usual 40-micrograms with an 80-microgram dose strategy of vaccine protection.
Detailed description
The objective of the present randomized study is to evaluate the optimum strategy of recombinant hepatitis B vaccination in the maintenance of protective anti-HBs antibody among end-stage renal disease patients on peritoneal dialysis. This study is designed to establish whether a three-dose schedule of 80 microgram Engerix-B vaccine could maintain protective antibody response among dialysis patients. The secondary aim is to identify the effects of dosing on various subgroups of dialysis patients.
Viral hepatitis B infection remains a major health hazard for end-stage renal disease patients on dialysis. The direct costs of hepatitis B infection and long term impact on morbidity and renal transplantation are substantial. Apart from the devastating consequences of hepatitis B infection on patients on dialysis or after transplantation, infected patients are potential reservoirs for infecting other patients and haemodialysis staff. Antibody production achieved in renal patients is suboptimal; the most effective method of vaccination to prevent hepatitis B infections in end-stage renal disease subjects has hitherto been unanswered by the current literature and the latest Cochrane Collaboration review.
Given the relatively low seroconversion rate and maintenance of protective hepatitis antibody levels among end-stage renal disease patients, a treatment strategy using various doses of recombinant hepatitis B vaccine (Engerix-B) has been recently explored. In an observational study, the investigators demonstrated no statistically significant difference in response rate between patients receiving three recommended doses of Engerix-B intramuscularly (40 micrograms each dose) and those with four times the normal adult dose (80 micrograms each dose), (78% versus 100%, P = 0.23). On the other hand, according to the Kaplan-Meier estimates, 78 percent of patients in the 40 micrograms Engerix-B vaccination group and 96 percent of patients in the 80 micrograms dosing group had maintained the seroprotective levels of antibody to hepatitis B surface antigen (anti-HBs) at 12 months after initial response. This difference corresponds to an absolute risk reduction of 18 percent for losing the antibody response with a three-dose schedule of 80 micrograms Engerix-B vaccination program. In other words, the investigators estimate that giving Engerix-B 80 micrograms dose would lead to one extra end-stage renal disease subject with persistent seroprotective anti-HBs level at one year for every 5.6 patients treated (number needed to treat to benefit NNT, 5.6; 95% confidence interval, 5.4 to 5.8).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Engerix-BEngerix-B 40 mcg dose |
| 2 | Active comparator | Biological: Engerix-BEngerix-B 80 mcg dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years
- End-stage renal disease and on maintenance peritoneal dialysis
- Serologically negative for hepatitis B surface antigen (HBsAg) and antibody to hepatitis core antigen (anti-HBc)
- No history of receiving hepatitis B vaccination
- Willingness to give written informed consent and willingness to participate in and comply with the study protocol
Key exclusion criteria (6 listed)
- Expected survival less than 6 months
- Those who refused vaccination
- Active malignancy
- Alcoholic liver disease
- Chronic hepatitis C and/or human immunodeficiency virus (HIV) infection
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 |
|---|---|---|
| Engerix-BEngerix-B at 0, 1, 6 months | Biological | 1, 2 |
Primary outcome
hepatitis B surface antibody anti-HBs level ≥ 10 IU/L 3 months after completion of the third dose and the persistence of protective anti-HBs 12 months after completion of the third dose of Engerix-B vaccine
Time frame: 18 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 7 Jan 2010.
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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.
Kai Ming Chow, MRCP principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Engerix-B in people with Peritoneal Dialysis and Renal Disease, End-Stage, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 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 7 Jan 2010. 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 Hong Kong. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
hepatitis B surface antibody anti-HBs level ≥ 10 IU/L 3 months after completion of the third dose and the persistence of protective anti-HBs 12 months after completion of the third dose of Engerix-B vaccine (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2010.