Immune Response Post Covid 19 VaccinationCovid-19NCT04872751
Immune Response of Haemodialysis Patients Post Covid-19 Vaccination
An observational study of Immune Response Post Covid 19 Vaccination, run by Penang Hospital, Malaysia at 1 site in Malaysia.
Trial summary
The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Response Post Covid 19 Vaccination
- How many people
- 425 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 Apr 2021to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage renal failure (ESRF) receiving hemodialysis
Who may be able to join
- ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme
- 18 years old and above
- consented to join the study
Who cannot join
- patient who refused to be vaccinated
- patient who deemed unsuitable for Covid vaccination
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Penang Hospital
George Town, Pulau Pinang, 10990
Ong Loke Meng, FRCS, 00 604 2225333 ext. 5767, onglokemeng@gmail.com
About this study
Official title: 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level
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.
Measured: up to one year
Secondary outcomes (1)
Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination)
Study the antibody synthesis and the change in its level after 1st inoculation of the vaccine
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start27 Apr 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Response Post Covid 19 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Ong Loke Meng, Penang Hospital, Malaysia
- Investigators
- LokeMeng Ong, Principal investigator, Penang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872751
- Sponsor's protocol ID
- NMRR-21-634-59445
- Acronym
- Covid-19
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Malaysian Study On Hemodialysis Patients SARS-COV-2 Vaccination Immune Response: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04872751
- Acronym / sponsor ID
- Covid-19 / NMRR-21-634-59445
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage renal failure (ESRF) receiving hemodialysis
Key inclusion criteria (3 listed)
- ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme
- 18 years old and above
- consented to join the study
Key exclusion criteria (2 listed)
- patient who refused to be vaccinated
- patient who deemed unsuitable for Covid vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination)
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LokeMeng Ong principal investigator
Penang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Response Post Covid 19 Vaccination, run by Penang Hospital, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XueFang Tan (6042225333 ext. 5576, xf821020@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.