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

November 1, 2021 updated by: Angsana Phuphuakrat, Mahidol University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

175

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • ฺBangkok
      • Ratchathewi, ฺBangkok, Thailand, 10400
        • Recruiting
        • Angsana Phuphuakrat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months of data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Ministry of Health, Thailand
Bhumirajanagarindra Kidney Institute, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 4, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (ACTUAL)

October 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2019/1116

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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