Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients

  • STATUS
    Recruiting
  • days left to enroll
    5
  • participants needed
    175
  • sponsor
    Mahidol University
Updated on 14 November 2021
vaccination
dialysis
chronic hemodialysis
trivalent influenza vaccine
Accepts healthy volunteers

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

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.

Details
Condition end stage renal failure, end stage renal disease, esrd, Kidney Failure (Pediatric), Chronic Kidney Disease Stage 5, trivalent influenza vaccine, chronic renal disease, Influenza Vaccine, Renal Failure, Kidney Failure, Stage 5 Chronic Kidney Disease, CKD Stage 5, renal insufficiency, influenza vaccines, end-stage renal disease, end-stage renal failure, end stage kidney disease, Seroprotection, Chronic renal failure, Influenza
Treatment Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
Clinical Study IdentifierNCT05070494
SponsorMahidol University
Last Modified on14 November 2021

Eligibility

Yes No Not Sure

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

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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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