Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients

NCT05070494 | Unknown Phase 4

• 1 other identifier: MURA2019/1116
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ESRD; Influenza Vaccine; Seroprotection

Keywords

ESRD; Influenza vaccine; double dose Influenza vaccine; double dose booster Influenza vaccine; Immune response

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

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

  12 months of data collection

Study Arms (4)

้healthy subject with standard dose trivalent influenza vaccine

OTHER

้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)

ESRD patient with standard dose trivalent influenza vaccine

ACTIVE COMPARATOR

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)

ESRD patient with double dose trivalent influenza vaccine

EXPERIMENTAL

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)

ESRD patient with double dose - booster trivalent influenza vaccine

EXPERIMENTAL

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

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

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

ESRD patient with double dose - booster trivalent influenza vaccine; ESRD patient with double dose trivalent influenza vaccine; ESRD patient with standard dose trivalent influenza vaccine; ้healthy subject with standard dose trivalent influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• Bhumirajanagarindra Kidney Institute, Thailand: collaborator
• Ministry of Health, Thailand: collaborator

Study Sites (1)

Angsana Phuphuakrat

Ratchathewi, ฺBangkok, 10400, Thailand

RECRUITING

Related Publications (20)

• 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.

  PMID: 25501062 BACKGROUND

• 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.

  PMID: 19996006 BACKGROUND

• 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.

  PMID: 21273232 BACKGROUND

• 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.

  PMID: 11742917 BACKGROUND

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

  PMID: 23202302 BACKGROUND

• 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.

  PMID: 11169012 BACKGROUND

• 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.

  PMID: 13679482 BACKGROUND

• 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.

  PMID: 17728708 BACKGROUND

• 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.

  PMID: 10910448 BACKGROUND

• 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.

  PMID: 10727545 BACKGROUND

• 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.

  PMID: 19406979 BACKGROUND

• 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.

  PMID: 23516462 BACKGROUND

• 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.

  PMID: 22493462 BACKGROUND

• 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.

  PMID: 12631142 BACKGROUND

• 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.

  PMID: 26247435 BACKGROUND

• 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.

  PMID: 24048214 BACKGROUND

• 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.

  PMID: 24421306 BACKGROUND

• 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.

  PMID: 26187260 BACKGROUND

• 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.

  PMID: 2512137 BACKGROUND

• 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.

  PMID: 27392026 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Kidney Failure, Chronic; Influenza, Human

Interventions

Influenza Vaccines; Antigens, Surface

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

Central Study Contacts

Angsana Phuphuakrat, MD, PhD

CONTACT

6622011581; angsana.phu@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Angsana Phuphuakrat

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: October 7, 2021
• Study Start: March 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-11

Locations

TH (1)