Immune Response of Haemodialysis Patients Post Covid-19 Vaccination (Covid-19)

May 4, 2021 updated by: Dr.Ong Loke Meng, Penang Hospital, Malaysia

The Malaysian Study On Hemodialysis Patients SARS-COV-2 Vaccination Immune Response: A Prospective Observational Cohort Study

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

425

Contacts and Locations

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

Study Contact

Study Locations

  • Malaysia
    • Penang
      • George Town, Penang, Malaysia, 10990
        • Recruiting
        • Penang Hospital
        • Contact:

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with end-stage renal failure (ESRF) receiving hemodialysis

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level
Time Frame: 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.
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination)
Time Frame: one month
Study the antibody synthesis and the change in its level after 1st inoculation of the vaccine
one month

Collaborators and Investigators

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

Sponsor

Penang Hospital, Malaysia

Investigators

  • Principal Investigator: LokeMeng Ong, Penang Hospital

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)

April 27, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR-21-634-59445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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