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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05070494
Study type Interventional
Source Mahidol University
Contact
Status Active, not recruiting
Phase Phase 4
Start date March 1, 2021
Completion date December 1, 2022

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