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

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05070494

Collaborator

Bhumirajanagarindra Kidney Institute, Thailand (Other), Ministry of Health, Thailand (Other)

175

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
ESRD Influenza Vaccine Seroprotection	Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)	Phase 4

Detailed Description

Patients with chronic kidney disease undergoing dialysis will be examined by an internist.
Collect the necessary basic information of patients who agree to participate in the treatment.
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.
Non-dialysis volunteers will be invited to participate in the research. to be a control group of 25 people
Patients with chronic kidney disease and volunteers will receive basic laboratory blood tests.
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.
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
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.
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

Study Type:

Interventional

Anticipated Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: ้healthy subject with standard dose trivalent influenza vaccine ้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) study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
Active Comparator: ESRD patient with standard dose trivalent influenza vaccine 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) study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
Experimental: ESRD patient with double dose trivalent influenza vaccine 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) study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
Experimental: ESRD patient with double dose - booster trivalent influenza vaccine 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) study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)

Outcome Measures

Primary Outcome Measures

To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12 [12 months]
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.

Secondary Outcome Measures

To compare the prevention of influenza virus infection in different doses of influenza vaccination. [12 months of data collection]
to compare incidence rate of influenza infection in different doses of influenza

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.