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
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