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Immune Response of Haemodialysis Patients Post Covid-19 Vaccination

Sponsor
Penang Hospital, Malaysia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04872751
Collaborator
(none)
425
Enrollment
1
Location
11.1
Anticipated Duration (Months)
38.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    425 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Malaysian Study On Hemodialysis Patients SARS-COV-2 Vaccination Immune Response: A Prospective Observational Cohort Study
    Actual Study Start Date :
    Apr 27, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level [up to one year]

      Study the antibody synthesis induced by vaccination, among end stage renal failure patients, and the change in its level at 1 month, at 6 months and at 1 year after complete vaccination.

    Secondary Outcome Measures

    1. Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination) [one month]

      Study the antibody synthesis and the change in its level after 1st inoculation of the vaccine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme

    • 18 years old and above

    • consented to join the study

    Exclusion Criteria:

    • patient who refused to be vaccinated

    • patient who deemed unsuitable for Covid vaccination

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Penang Hospital George Town Penang Malaysia 10990

    Sponsors and Collaborators

    • Penang Hospital, Malaysia

    Investigators

    • Principal Investigator: LokeMeng Ong, Penang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr.Ong Loke Meng, Doctor, Penang Hospital, Malaysia
    ClinicalTrials.gov Identifier:
    NCT04872751
    Other Study ID Numbers:
    • NMRR-21-634-59445
    First Posted:
    May 4, 2021
    Last Update Posted:
    May 7, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of May 7, 2021