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Status unknownNCT05070494EnhanceUpdated Nov 3, 2021

Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients

A Phase 4 interventional study of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) in ESRD, Influenza Vaccine and Seroprotection, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-03.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2021, registered Sep 2021).
Phase
Phase 4
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study was a randomized controlled trial to investigate the immune response of influenza vaccines when doses were increased. and a second vaccination together with an increase in the amount of vaccine in patients with chronic kidney disease receiving hemodialysis

Read the detailed description
  1. Patients with chronic kidney disease undergoing dialysis will be examined by an internist.
  2. Collect the necessary basic information of patients who agree to participate in the treatment.
  3. Patients will be randomized to be divided into 3 groups: those who will receive an standard dose of influenza vaccine, those who will receive double standard dose of influenza vaccine (double-dose) and those who will receive double standard dose of influenza vaccine and Six months after the first dose of vaccination (double-booster-dose), 50 people per group.
  4. Non-dialysis volunteers will be invited to participate in the research. to be a control group of 25 people
  5. Patients with chronic kidney disease and volunteers will receive basic laboratory blood tests.
  6. Patients with chronic kidney disease and volunteers will be vaccinated against influenza. shoulder muscle area according to random groups The details of using Influvac vaccine of that year are produced by Abbott.
  7. Patients with chronic kidney disease and volunteers are asked about the potential side effects of vaccination. according to research guidelines both systemic side effects and injection site Each time receiving hemodialysis 3 times a week for 2 weeks after vaccination
  8. Patients with chronic kidney disease and volunteers were asked about the onset of symptoms of respiratory infection throughout the 12-month study period after vaccination.
  9. Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at 1, 6, 7 and 12 months after influenza vaccination.
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Conditions studied

  • ESRD
  • Influenza Vaccine
  • Seroprotection

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Keywords

  • ESRD
  • Influenza vaccine
  • double dose Influenza vaccine
  • double dose booster Influenza vaccine
  • Immune response
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In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 175 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age ≥18 years
  • Received kidney replacement therapy with dialysis for more than 1 month.
  • Hemodialysis at least 3 times a week
  • (Kt/v) greater than 1.2
  • Never received an organ transplant.
  • Life expectancy of more than 1 year
  • Research participants or representatives are welcome to join the project by signing.

Exclusion criteria

Exclusion Criteria:

  • History of any vaccinations in the 4 weeks prior to the study.
  • History of receiving influenza vaccine 6 months before entering this study.
  • History of allergy to flu vaccine or allergic to egg white
  • Fever or headache, muscle pain (influenza-like illness) 3 days before vaccination
  • Thrombocytopenia
  • On immunosuppressive drug (Prednisolone 15 mg daily or equivalent for two weeks in a row in the previous 3 months) or immunocompromised patient
  • Patient or family history of having had Guillain-Barre disease. (Guillain-Barre syndrome)
  • The research participant or his representative refuses or requests to withdraw.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
175 participants (estimated)

Study arms

  • Other
    ้healthy subject with standard dose trivalent influenza vaccine

    ้healthy volunteer that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain)

    Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)

  • Active comparator
    ESRD patient with standard dose trivalent influenza vaccine

    ESRD patient that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain)

    Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)

  • Experimental
    ESRD patient with double dose trivalent influenza vaccine

    ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) total 1 ml ( 1 ml /(30 mcg/strain)

    Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)

  • Experimental
    ESRD patient with double dose - booster trivalent influenza vaccine

    ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) and booster with Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) at next 6 months after first dose

    Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)

Interventions

  • BiologicalEgg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)

    study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)

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What researchers measure

Primary outcomes

  1. To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12

    Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at month 12 after influenza vaccination.

    Time frame: 12 months

Secondary outcomes

  1. To compare the prevention of influenza virus infection in different doses of influenza vaccination.

    to compare incidence rate of influenza infection in different doses of influenza

    Time frame: 12 months of data collection

07

Study locations

1 of 1 sites recruiting
  • Angsana Phuphuakrat
    Ratchathewi, ฺBangkok 10400, Thailand
    Recruiting
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References and documents

Publications

  • 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 ↗
  • 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 ↗
  • 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 ↗
  • Meier P, Golshayan D, Blanc E, Pascual M, Burnier M. Oxidized LDL modulates apoptosis of regulatory T cells in patients with ESRD. J Am Soc Nephrol. 2009 Jun;20(6):1368-84. doi: 10.1681/ASN.2008070734. Epub 2009 Apr 30. PubMed 19406979 ↗
  • Wang IK, Lin CL, Lin PC, Liang CC, Liu YL, Chang CT, Yen TH, Morisky DE, Huang CC, Sung FC. Effectiveness of influenza vaccination in patients with end-stage renal disease receiving hemodialysis: a population-based study. PLoS One. 2013;8(3):e58317. doi: 10.1371/journal.pone.0058317. Epub 2013 Mar 13. PubMed 23516462 ↗
  • McGrath LJ, Kshirsagar AV, Cole SR, Wang L, Weber DJ, Sturmer T, Brookhart MA. Influenza vaccine effectiveness in patients on hemodialysis: an analysis of a natural experiment. Arch Intern Med. 2012 Apr 9;172(7):548-54. doi: 10.1001/archinternmed.2011.2238. PubMed 22493462 ↗
  • Gilbertson DT, Unruh M, McBean AM, Kausz AT, Snyder JJ, Collins AJ. Influenza vaccine delivery and effectiveness in end-stage renal disease. Kidney Int. 2003 Feb;63(2):738-43. doi: 10.1046/j.1523-1755.2003.00787.x. PubMed 12631142 ↗
  • Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season. MMWR Morb Mortal Wkly Rep. 2015 Aug 7;64(30):818-25. doi: 10.15585/mmwr.mm6430a3. PubMed 26247435 ↗
  • Centers for Disease Control and Prevention (CDC). Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. MMWR Recomm Rep. 2013 Sep 20;62(RR-07):1-43. Erratum In: MMWR Recomm Rep. 2013 Nov 15;62(45):906. PubMed 24048214 ↗
  • Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, Bousvaros A, Dhanireddy S, Sung L, Keyserling H, Kang I; Infectious Diseases Society of America. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014 Feb;58(3):309-18. doi: 10.1093/cid/cit816. Erratum In: Clin Infect Dis. 2014 Jul 1;59(1):144. PubMed 24421306 ↗
  • DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty. Vaccine. 2015 Aug 26;33(36):4565-71. doi: 10.1016/j.vaccine.2015.07.003. Epub 2015 Jul 14. PubMed 26187260 ↗
  • Rautenberg P, Proppe D, Schutte A, Ullmann U. Influenza subtype-specific immunoglobulin A and G responses after booster versus one double-dose vaccination in hemodialysis patients. Eur J Clin Microbiol Infect Dis. 1989 Oct;8(10):897-900. doi: 10.1007/BF01963779. PubMed 2512137 ↗
  • Liao Z, Xu X, Liang Y, Xiong Y, Chen R, Ni J. Effect of a booster dose of influenza vaccine in patients with hemodialysis, peritoneal dialysis and renal transplant recipients: A systematic literature review and meta-analysis. Hum Vaccin Immunother. 2016 Nov;12(11):2909-2915. doi: 10.1080/21645515.2016.1201623. Epub 2016 Jul 8. PubMed 27392026 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05070494
Lead sponsor
Mahidol University
Collaborators
Bhumirajanagarindra Kidney Institute, Thailand, Ministry of Health, Thailand
Responsible party
Angsana Phuphuakrat (Angsana Phuphuakrat, Mahidol University) — Principal investigator
First posted
Oct 7, 2021
Start date
Mar 1, 2021
Primary completion
Apr 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Nov 3, 2021

Study contacts

Angsana Phuphuakrat, MD, PhD
Contact
angsana.phu@mahidol.ac.th
6622011581

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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