AzTrials
AzTrials

ImmunologyNCT04122222

Immune Response to Influenza Vaccine in ESRD Patients

A study testing Influenza vaccine in people with Immunology and Nephrology, run by Mahidol University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

On-line hemodiafiltration (HDF) clears more azotaemic toxins compared to high-flux hemodialysis (HD). The response to vaccination is impaired in dialysis patients. We aimed to study the immune responses to influenza vaccine in dialysis patients treated by HDF vs. HD. Read more about this study

Who is it for?
Any age
Conditions the study is for
Immunology, Nephrology
What is being tested?
Influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
25 Aug 2016to 20 Jul 2018
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • ESRD patients aged 18 years or older, who had been treated for more than one month of either thrice weekly on-line hemodiafiltration (HDF) or conventional high flux hemodialysis (HD), with a session dialyzer urea clearance (Kt/V urea) of 1.2 and greater, with a convection volume target of 20 L/session for the HDF group

Who cannot join

  • Had received any vaccination within the previous four weeks, or influenza vaccination within six months
  • Patient who reported upper respiratory tract symptoms within three days prior to the study vaccination
  • A history of allergy to influenza vaccine or egg
  • Thrombocytopenia
  • In receipt of immunosuppressant medications, chemotherapy, or had immunodeficiency

About this study

Official title: Immune Response to Influenza Vaccination in ESRD Patients Undergoing Hemodialysis vs. Hemodiafiltration

On-line hemodiafiltration (HDF) clears more azotaemic toxins compared to high-flux hemodialysis (HD). The response to vaccination is impaired in dialysis patients. We aimed to study the immune responses to influenza vaccine in dialysis patients treated by HDF vs. HD.

Being tested
Influenza vaccine
Keywords
ESRD, hemodialysis, hemodiafiltration, influenza vaccine, immune response
Medical subject headings
Kidney Failure, Chronic, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza vaccineBiological

    Also called A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.

    A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.

Study groups in NCT04122222
Study groupRoleWhat they receive
HemodialysisActive comparatorESRD patients treated by hemodialysis
Receives: Biological: Influenza vaccine
HemodiafiltrationActive comparatorESRD patients treated by on-line hemodiafiltration
Receives: Biological: Influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. measurement antibody titers, determined by hemagglutination inhibition (HI) assay.

    measurement antibody titers, determined by hemagglutination inhibition (HI) assay.

    Measured: 12 months

Secondary outcomes (1)

  1. measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.

    measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start25 Aug 2016
  3. Primary completion20 Jul 2018
  4. Study completion20 Jul 2018

Resources

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 N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
* A prospective cohort study in chronic dialysis patients during the 2016 and 2017 influenza seasons * All participants received a single standard dose of trivalent influenza vaccine * The elicited humoral immune response by hemagglutination inhibition test, and cell-mediated immune response by enumeration of lymphocyte cellular markers and proliferation assays are studied.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04122222
Sponsor's protocol ID
07-59-14
Status last verified
Oct 2019
First submitted
3 Oct 2019
Last updated
10 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: International journal involving immunology and/or nephrology

Publications

  • Descamps-Latscha B. The immune system in end-stage renal disease. Curr Opin Nephrol Hypertens. 1993 Nov;2(6):883-91. doi: 10.1097/00041552-199311000-00005.

    PubMed 7922228

  • Hauser AB, Stinghen AE, Kato S, Bucharles S, Aita C, Yuzawa Y, Pecoits-Filho R. Characteristics and causes of immune dysfunction related to uremia and dialysis. Perit Dial Int. 2008 Jun;28 Suppl 3:S183-7.

    PubMed 18552253

  • Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.

    PubMed 18701615

  • Cohen G, Horl WH. Immune dysfunction in uremia—an update. Toxins (Basel). 2012 Oct 24;4(11):962-90. doi: 10.3390/toxins4110962.

    PubMed 23202302

  • Girndt M, Sester M, Sester U, Kaul H, Kohler H. Molecular aspects of T- and B-cell function in uremia. Kidney Int Suppl. 2001 Feb;78:S206-11. doi: 10.1046/j.1523-1755.2001.59780206.x.

    PubMed 11169012

  • Meijers RW, Litjens NH, de Wit EA, Langerak AW, van der Spek A, Baan CC, Weimar W, Betjes MG. Uremia causes premature ageing of the T cell compartment in end-stage renal disease patients. Immun Ageing. 2012 Sep 12;9(1):19. doi: 10.1186/1742-4933-9-19.

    PubMed 22971545

  • Anding K, Gross P, Rost JM, Allgaier D, Jacobs E. The influence of uraemia and haemodialysis on neutrophil phagocytosis and antimicrobial killing. Nephrol Dial Transplant. 2003 Oct;18(10):2067-73. doi: 10.1093/ndt/gfg330.

    PubMed 13679482

  • Lim WH, Kireta S, Leedham E, Russ GR, Coates PT. Uremia impairs monocyte and monocyte-derived dendritic cell function in hemodialysis patients. Kidney Int. 2007 Nov;72(9):1138-48. doi: 10.1038/sj.ki.5002425. Epub 2007 Aug 29.

    PubMed 17728708

  • Sester U, Sester M, Hauk M, Kaul H, Kohler H, Girndt M. T-cell activation follows Th1 rather than Th2 pattern in haemodialysis patients. Nephrol Dial Transplant. 2000 Aug;15(8):1217-23. doi: 10.1093/ndt/15.8.1217.

    PubMed 10910448

  • Fernandez-Fresnedo G, Ramos MA, Gonzalez-Pardo MC, de Francisco AL, Lopez-Hoyos M, Arias M. B lymphopenia in uremia is related to an accelerated in vitro apoptosis and dysregulation of Bcl-2. Nephrol Dial Transplant. 2000 Apr;15(4):502-10. doi: 10.1093/ndt/15.4.502.

    PubMed 10727545

  • Chou CY, Wang SM, Liang CC, Chang CT, Liu JH, Wang IK, Hsiao LC, Muo CH, Huang CC, Wang RY. Risk of pneumonia among patients with chronic kidney disease in outpatient and inpatient settings: a nationwide population-based study. Medicine (Baltimore). 2014 Dec;93(27):e174. doi: 10.1097/MD.0000000000000174.

    PubMed 25501062

  • Collins AJ, Foley RN, Gilbertson DT, Chen SC. The state of chronic kidney disease, ESRD, and morbidity and mortality in the first year of dialysis. Clin J Am Soc Nephrol. 2009 Dec;4 Suppl 1:S5-11. doi: 10.2215/CJN.05980809.

    PubMed 19996006

  • Viasus D, Garcia-Vidal C, Cruzado JM, Adamuz J, Verdaguer R, Manresa F, Dorca J, Gudiol F, Carratala J. Epidemiology, clinical features and outcomes of pneumonia in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Sep;26(9):2899-906. doi: 10.1093/ndt/gfq798. Epub 2011 Jan 27.

    PubMed 21273232

  • Sarnak MJ, Jaber BL. Pulmonary infectious mortality among patients with end-stage renal disease. Chest. 2001 Dec;120(6):1883-7. doi: 10.1378/chest.120.6.1883.

    PubMed 11742917

  • Nordio M, Limido A, Maggiore U, Nichelatti M, Postorino M, Quintaliani G; Italian Dialysis and Transplantation Registry. Survival in patients treated by long-term dialysis compared with the general population. Am J Kidney Dis. 2012 Jun;59(6):819-28. doi: 10.1053/j.ajkd.2011.12.023. Epub 2012 Feb 22.

    PubMed 22361043

Questions about this trial

What is this clinical trial studying?

A study testing Influenza vaccine in people with Immunology and Nephrology, run by Mahidol University.

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 1 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

measurement antibody titers, determined by hemagglutination inhibition (HI) assay. (time frame: 12 months). 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 NCT04122222, which also lists 34 linked publications.

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 10 Oct 2019.

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