Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis

Status Recruiting

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

Clinical Trial Details

NCT number	NCT05070494
Study type	Interventional
Source	Mahidol University
Contact	Angsana Phuphuakrat, MD, PhD
Phone	6622011581
Email	angsana.phu@mahidol.ac.th
Status	Recruiting
Phase	Phase 4
Start date	March 1, 2021
Completion date	December 1, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients — Enhance

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms