HemodialysisPhase 4NCT00776750
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
A Phase 4 study testing trivalent split influenza vaccine in people with Hemodialysis and Renal Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Renal Transplantation
- What is being tested?
- trivalent split influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2003to May 2004
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- maintenance hemodialysis patients or
- renal transplant recipients (beyond month 3 after transplantation)
Who cannot join
- patients with known allergy to chicken proteins
Trial locations and contacts
1 site in 1 country.
About this study
Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). The present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b) at identifying determinants of the immune response.
- Conditions
- Hemodialysis, Renal Transplantation
- Being tested
- trivalent split influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent split influenza vaccineBiological
standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| influenza vaccination | Experimental | All participants received a standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection. The vaccine contained 15 μg hemagglutinin of each of the following influenza strains: A/ New Caledonia/20/99 (H1N1), A/ Panama/2007/99 (H3N2), and B/Shangdong/7/97, recommended by WHO as components of the influenza vaccine for the epidemic season 2003/2004. Receives: Biological: trivalent split influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
Secondary outcomes (1)
Seroresponse rate, defined as the percentage of patients with a fourfold rise in HI titer after vaccination; impact of booster vaccination on the immune response, and safety of influenza vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startSep 2003
- Primary completionMay 2004
- Study completionMay 2004
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 HemodialysisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Investigators
- Yves Vanrenterghem, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776750
- Sponsor's protocol ID
- ML2394
- Status last verified
- Oct 2008
- First submitted
- 20 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Scharpe J, Peetermans WE, Vanwalleghem J, Maes B, Bammens B, Claes K, Osterhaus AD, Vanrenterghem Y, Evenepoel P. Immunogenicity of a standard trivalent influenza vaccine in patients on long-term hemodialysis: an open-label trial. Am J Kidney Dis. 2009 Jul;54(1):77-85. doi: 10.1053/j.ajkd.2008.11.032. Epub 2009 Apr 1.
PubMed 19339089
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00776750
- Acronym / sponsor ID
- ML2394
- Conditions
- Hemodialysis, Renal Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- May 2004
- Study completion
- May 2004
- First posted
- 21 Oct 2008 (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.
Disturbances of acquired immunity are considered to be responsible, at least partly, for the high infection rate and inadequate response to vaccinations observed in hemodialysis (HD) patients and renal transplant recipient (RTR). The present prospective trial aims at (a) evaluating the immunogenicity of a standard influenza vaccine in HD and RTR patients and (b) at identifying determinants of the immune response.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| influenza vaccination | Experimental | Biological: trivalent split influenza vaccineAll participants received a standard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection. The vaccine contained 15 μg hemagglutinin of each of the following influenza strains: A/ New Caledonia/20/99 (H1N1), A/ Panama/2007/99 (H3N2), and B/Shangdong/7/97, recommended by WHO as components of the influenza vaccine for the epidemic season 2003/2004. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- maintenance hemodialysis patients or
- renal transplant recipients (beyond month 3 after transplantation)
Key exclusion criteria (1 listed)
- patients with known allergy to chicken proteins
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 |
|---|---|---|
| trivalent split influenza vaccinestandard dose of 0.5 ml commercially available trivalent split influenza vaccine (Vaxigrip®, Aventis Pasteur MSD) by intramuscular injection | Biological | influenza vaccination |
Primary outcome
Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,
1 secondary outcome
Seroresponse rate, defined as the percentage of patients with a fourfold rise in HI titer after vaccination; impact of booster vaccination on the immune response, and safety of influenza vaccination.
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 21 Oct 2008.
- Derived from this study: PubMed 19339089Scharpe J, Peetermans WE, Vanwalleghem J, Maes B, Bammens B, Claes K, Osterhaus AD, Vanrenterghem Y, Evenepoel P. Immunogenicity of a standard trivalent influenza vaccine in patients on long-term hemodialysis: an open-label trial. Am J Kidney Dis. 2009 Jul;54(1):77-85. doi: 10.1053/j.ajkd.2008.11.032. Epub 2009 Apr 1.
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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.
Yves Vanrenterghem, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 trivalent split influenza vaccine in people with Hemodialysis and Renal Transplantation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 1 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 21 Oct 2008. 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 Belgium. 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?
Seroprotection rate, defined as the percentage of patients with an HI antibody titer ≥ 40,. 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 NCT00776750, 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 21 Oct 2008.