NCT05070494

Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients

Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients: Randomized Controlled Trial (Enhance Study)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• ESRD
• Influenza Vaccine
• Seroprotection

Interventions

Type	Name	Description
BIOLOGICAL	Egg-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)

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-04-01
• Completion: 2022-12-01
• First posted: 2021-10-07
• Last updated: 2021-11-03

Locations

1 site across 1 country: Thailand