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Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients (Enhance)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05070494
Recruitment Status : Recruiting
First Posted : October 7, 2021
Last Update Posted : November 3, 2021
Sponsor:
Collaborators:
Bhumirajanagarindra Kidney Institute, Thailand
Ministry of Health, Thailand
Information provided by (Responsible Party):
Angsana Phuphuakrat, Mahidol University

Study Description
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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:
  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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
้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
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Primary Outcome Measures :
  1. To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12 [ Time Frame: 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 :
  1. To compare the prevention of influenza virus infection in different doses of influenza vaccination. [ Time Frame: 12 months of data collection ]
    to compare incidence rate of influenza infection in different doses of influenza


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05070494


Contacts
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Contact: Angsana Phuphuakrat, MD, PhD 6622011581 angsana.phu@mahidol.ac.th

Locations
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Thailand
Angsana Phuphuakrat Recruiting
Ratchathewi, ฺBangkok, Thailand, 10400
Contact: Angsana Phuphuakrat, MD, PhD    6622011581    angsana.phu@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University
Bhumirajanagarindra Kidney Institute, Thailand
Ministry of Health, Thailand
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

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Responsible Party: Angsana Phuphuakrat, Mahidol University
ClinicalTrials.gov Identifier: NCT05070494    
Other Study ID Numbers: MURA2019/1116
First Posted: October 7, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Angsana Phuphuakrat, Mahidol University:
ESRD
Influenza vaccine
double dose Influenza vaccine
double dose booster Influenza vaccine
Immune response
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases