Covid19NCT05057936
Antibody After COVID-19 Vaccination
An observational study of Covid19 and Breakthrough Infection, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
Trial summary
Chronic kidney disease (CKD) including patients on dialysis and kidney transplant recipients. represents the special subgroups of patients that required protection during the Severe Coronavirus Disease 2019 (COVID-19) pandemic .Since COVID-19 is associated with severe morbidity and mortality in these particular… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Breakthrough Infection, CKD
- What is being tested?
- COVID vaccine
- Type of treatment
- Vaccines
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD stage 3-5 and those require renal replacment therapy with HD,CAPD or Kidney trasnplantation
Who may be able to join
- CKD stage 3-5 (eGFR < 60 mL/min/1.73m3)
- CKD stage 5 patients receiving HD,CAPD and KT for more than 3 months.
- The participants of the healthy control group consists of volunteer health care workers who had been vaccinated according to the nation vaccination schedule
Who cannot join
- allergy to the components of vaccines
- unable to receive the vaccine according to the schedule
- fever or concomitant serious illnesses
- had side effect from the first dose of vaccination
- prior COVID-19 infection in the past (diagnosed via patients history and serological test for nucleocapsid (NCP) antibody
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibody Response After COVID-19 Vaccination in Chronic Kidney Disease and Kidney Transplant Patients
Chronic kidney disease (CKD) including patients on dialysis and kidney transplant recipients. represents the special subgroups of patients that required protection during the Severe Coronavirus Disease 2019 (COVID-19) pandemic .Since COVID-19 is associated with severe morbidity and mortality in these particular subgroup of patients, the main strategies is proper and rapid vaccination. CKD patients usually have a reduced immune responses, vaccination in these group of patients usually require higher dosage and more frequent dose since the vaccine response is short-lived and less response especially in dialysis patients5 .In patients with normal renal function,the immunity is durable but with modest declines at 6-8months. One study showed a linear decline in IgG in dialysis patients for up to 3months , but there are otherwise limited data.
Previous reports of the vaccination in CKD patient involved mainly the mRNA vaccines. The recent reports of seroconversion rate dialysis patients receiving two doses of BNT 162b2 vaccine (Pfizer BioNtech) was lower than in control. In Thailand, the main vaccines available are Coronavac (Sinovac Life Science, Beijing, China) and ChadOx1 nCoV-19 (Oxford-Astra Zeneca) which was dispensed all over the country since April 2021. Data of the efficacy and safety of these vaccines in these patient groups is lacking. Therefore, the aim of this study is to measure the antibody and cellular responses in CKD patients including those with dialysis therapy and kidney transplantation and monitor the adverse events after the first and second doses of after vaccination. The incidence rate of Sars-COV2 infection post vaccination was also observed.
Read the detailed description
This is a prospective cohort study that included 4 different cohorts i.e CKD ,hemodialysis ( HD), continuous ambulatory peritoneal dialysis (CAPD) , kidney transplant (KT) patients and a control group without kidney failure at Faculty of Medicine, Vajira Hospital,Navamindradhiraj University from June -December 2021. The inclusion criteria were CKD stage 3-5 (eGFR < 60 mL/min/1.73m3), CKD patients receiving HD,CAPD and KT. The participants of the healthy control group consists of volunteer health care workers who had been vaccinated according to the nation vaccination schedule. Participants in both groups needed to be 18-90 years old. The exclusion criteria were allergy to the components of vaccines, unable to receive the vaccine according to the schedule,fever or concomitant serious illnesses and had side effect from the first dose of vaccination. Patients or individuals with prior COVID-19 infection in the past (diagnosed via patients history and serological test for nucleocapsid (NCP) antibody were excluded from the study. The study protocol was approved by the local Ethics Committed and participants were enrolled after written informed consent was obtained. The study who performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The vaccine used was authorized by the Thai Food and Drug Administration and the Department of Medical Sciences (DMS).
- Conditions
- Covid19, Breakthrough Infection, CKD, Kidney Transplant, Vaccination
- Being tested
- COVID vaccine
- Keywords
- COVID-19, vaccine, Neutralising antibody, chronic kidney disease, kidney transplant, anti-spike RBD IgG, nucleocapsid antibody, interferon gamma
- Medical subject headings
- COVID-19, Breakthrough Infections, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID vaccineBiological
The enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy healthcare workers Receives: Biological: COVID vaccine | |
| Chronic kidney disease (CKD) | CKD stage 3-5 (eGFR < 60 mL/min/1.73m3) Receives: Biological: COVID vaccine | |
| Dialysis patients | CKD stage 5 requiring HD Receives: Biological: COVID vaccine | |
| kidney transplant patients | patients receiving kidney transplantation for more than 3 months Receives: Biological: COVID vaccine | |
| dialysis patients | CKD patients requring continuos ambulatory peritoneal dialysis Receives: Biological: COVID vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity after COVID-19 vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Measured: Baseline before vaccination
Immunogenicity after COVID-19 vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Measured: The second dose of vaccination
Immunogenicity after COVID-19 vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Measured: Eight weeks after the second dose of vaccination
Immunogenicity after COVID-19 vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Measured: Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Measured: The second dose of vaccination
Immunogenicity after COVID-19 vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Measured: Eight weeks after the second dose of vaccination
Immunogenicity after COVID-19 vaccination
Cellular immunity by interferon gamma level
Measured: Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Cellular immunity by interferon gamma level
Measured: The second dose of vaccination
Immunogenicity after COVID-19 vaccination
Cellular immunity by interferon gamma level
Measured: Eight weeks after the second dose of vaccination
Secondary outcomes (2)
rates of adverse events after vaccination
drug allergy ,skin rash,liver toxicity
Measured: 28 days
the incidence of COVID-19 breakthrough infection after vaccination
number of cases that develop COVID-19 infection after vaccination
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057936
- Sponsor's protocol ID
- 101/64
- Status last verified
- Jan 2022
- First submitted
- 23 Sep 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that present in this study will be deposited in Mendeley osother data repository sited as appropriate
Publications
Hilbrands LB, Duivenvoorden R, Vart P, Franssen CFM, Hemmelder MH, Jager KJ, Kieneker LM, Noordzij M, Pena MJ, Vries H, Arroyo D, Covic A, Crespo M, Goffin E, Islam M, Massy ZA, Montero N, Oliveira JP, Roca Munoz A, Sanchez JE, Sridharan S, Winzeler R, Gansevoort RT; ERACODA Collaborators. COVID-19-related mortality in kidney transplant and dialysis patients: results of the ERACODA collaboration. Nephrol Dial Transplant. 2020 Nov 1;35(11):1973-1983. doi: 10.1093/ndt/gfaa261.
PubMed 33151337Kengibe PY, Makulo JR, Nlandu YM, Lepira FB, Sumaili EK, Bukabau JB, Mbendi CN, Ahuka SM, Tshimpi AW, Ngoma PK, Mangani NN, Mbendi SN. Response to single dose hepatitis B vaccine in Congolese non-HIV hemodialysis patients: a prospective observational study. Pan Afr Med J. 2019 Oct 31;34:122. doi: 10.11604/pamj.2019.34.122.19603. eCollection 2019.
PubMed 33708291Bensouna I, Caudwell V, Kubab S, Acquaviva S, Pardon A, Vittoz N, Bozman DF, Hanafi L, Faucon AL, Housset P. SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis. Am J Kidney Dis. 2022 Feb;79(2):185-192.e1. doi: 10.1053/j.ajkd.2021.08.005. Epub 2021 Sep 8.
PubMed 34508833Carr EJ, Kronbichler A, Graham-Brown M, Abra G, Argyropoulos C, Harper L, Lerma EV, Suri RS, Topf J, Willicombe M, Hiremath S. Review of Early Immune Response to SARS-CoV-2 Vaccination Among Patients With CKD. Kidney Int Rep. 2021 Sep;6(9):2292-2304. doi: 10.1016/j.ekir.2021.06.027. Epub 2021 Jul 6.
PubMed 34250319Grupper A, Sharon N, Finn T, Cohen R, Israel M, Agbaria A, Rechavi Y, Schwartz IF, Schwartz D, Lellouch Y, Shashar M. Humoral Response to the Pfizer BNT162b2 Vaccine in Patients Undergoing Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2021 Jul;16(7):1037-1042. doi: 10.2215/CJN.03500321. Epub 2021 Apr 6.
PubMed 33824157Labriola L, Scohy A, Seghers F, Perlot Q, De Greef J, Desmet C, Romain C, Morelle J, Yombi JC, Kabamba B, Rodriguez-Villalobos H, Jadoul M. A Longitudinal, 3-Month Serologic Assessment of SARS-CoV-2 Infections in a Belgian Hemodialysis Facility. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):613-614. doi: 10.2215/CJN.12490720. Epub 2020 Nov 18. No abstract available.
PubMed 33208402Ikizler TA, Coates PT, Rovin BH, Ronco P. Immune response to SARS-CoV-2 infection and vaccination in patients receiving kidney replacement therapy. Kidney Int. 2021 Jun;99(6):1275-1279. doi: 10.1016/j.kint.2021.04.007. Epub 2021 Apr 20.
PubMed 33931226Torreggiani M, Blanchi S, Fois A, Fessi H, Piccoli GB. Neutralizing SARS-CoV-2 antibody response in dialysis patients after the first dose of the BNT162b2 mRNA COVID-19 vaccine: the war is far from being won. Kidney Int. 2021 Jun;99(6):1494-1496. doi: 10.1016/j.kint.2021.04.010. Epub 2021 Apr 20. No abstract available.
PubMed 33887320Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20.
PubMed 32702298
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Response After COVID-19 Vaccination in Chronic Kidney Disease and Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT05057936
- Acronym / sponsor ID
- 101/64
- Conditions
- Covid19, Breakthrough Infection, CKD, Kidney Transplant, Vaccination
- Keywords
- COVID-19, vaccine, Neutralising antibody, chronic kidney disease, kidney transplant, anti-spike RBD IgG, nucleocapsid antibody, interferon gamma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Sep 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.
Chronic kidney disease (CKD) including patients on dialysis and kidney transplant recipients. represents the special subgroups of patients that required protection during the Severe Coronavirus Disease 2019 (COVID-19) pandemic .Since COVID-19 is associated with severe morbidity and mortality in these particular subgroup of patients, the main strategies is proper and rapid vaccination. CKD patients usually have a reduced immune responses, vaccination in these group of patients usually require higher dosage and more frequent dose since the vaccine response is short-lived and less response especially in dialysis patients5 .In patients with normal renal function,the immunity is durable but with modest declines at 6-8months. One study showed a linear decline in IgG in dialysis patients for up to 3months , but there are otherwise limited data.
Previous reports of the vaccination in CKD patient involved mainly the mRNA vaccines. The recent reports of seroconversion rate dialysis patients receiving two doses of BNT 162b2 vaccine (Pfizer BioNtech) was lower than in control. In Thailand, the main vaccines available are Coronavac (Sinovac Life Science, Beijing, China) and ChadOx1 nCoV-19 (Oxford-Astra Zeneca) which was dispensed all over the country since April 2021. Data of the efficacy and safety of these vaccines in these patient groups is lacking. Therefore, the aim of this study is to measure the antibody and cellular responses in CKD patients including those with dialysis therapy and kidney transplantation and monitor the adverse events after the first and second doses of after vaccination. The incidence rate of Sars-COV2 infection post vaccination was also observed.
Detailed description
This is a prospective cohort study that included 4 different cohorts i.e CKD ,hemodialysis ( HD), continuous ambulatory peritoneal dialysis (CAPD) , kidney transplant (KT) patients and a control group without kidney failure at Faculty of Medicine, Vajira Hospital,Navamindradhiraj University from June -December 2021. The inclusion criteria were CKD stage 3-5 (eGFR < 60 mL/min/1.73m3), CKD patients receiving HD,CAPD and KT. The participants of the healthy control group consists of volunteer health care workers who had been vaccinated according to the nation vaccination schedule. Participants in both groups needed to be 18-90 years old. The exclusion criteria were allergy to the components of vaccines, unable to receive the vaccine according to the schedule,fever or concomitant serious illnesses and had side effect from the first dose of vaccination. Patients or individuals with prior COVID-19 infection in the past (diagnosed via patients history and serological test for nucleocapsid (NCP) antibody were excluded from the study. The study protocol was approved by the local Ethics Committed and participants were enrolled after written informed consent was obtained. The study who performed in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The vaccine used was authorized by the Thai Food and Drug Administration and the Department of Medical Sciences (DMS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | – | Biological: COVID vaccineHealthy healthcare workers |
| Chronic kidney disease (CKD) | – | Biological: COVID vaccineCKD stage 3-5 (eGFR < 60 mL/min/1.73m3) |
| Dialysis patients | – | Biological: COVID vaccineCKD stage 5 requiring HD |
| kidney transplant patients | – | Biological: COVID vaccinepatients receiving kidney transplantation for more than 3 months |
| dialysis patients | – | Biological: COVID vaccineCKD patients requring continuos ambulatory peritoneal dialysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD stage 3-5 and those require renal replacment therapy with HD,CAPD or Kidney trasnplantation
Key inclusion criteria (3 listed)
- CKD stage 3-5 (eGFR < 60 mL/min/1.73m3)
- CKD stage 5 patients receiving HD,CAPD and KT for more than 3 months.
- The participants of the healthy control group consists of volunteer health care workers who had been vaccinated according to the nation vaccination schedule
Key exclusion criteria (5 listed)
- allergy to the components of vaccines
- unable to receive the vaccine according to the schedule
- fever or concomitant serious illnesses
- had side effect from the first dose of vaccination
- prior COVID-19 infection in the past (diagnosed via patients history and serological test for nucleocapsid (NCP) antibody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID vaccineThe enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses | Biological | Chronic kidney disease (CKD), Control, Dialysis patients, dialysis patients, kidney transplant patients |
Primary outcome
Immunogenicity after COVID-19 vaccination
Time frame: Baseline before vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Immunogenicity after COVID-19 vaccination
Time frame: The second dose of vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Immunogenicity after COVID-19 vaccination
Time frame: Eight weeks after the second dose of vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Immunogenicity after COVID-19 vaccination
Time frame: Baseline before vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Immunogenicity after COVID-19 vaccination
Time frame: The second dose of vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Immunogenicity after COVID-19 vaccination
Time frame: Eight weeks after the second dose of vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Immunogenicity after COVID-19 vaccination
Time frame: Baseline before vaccination
Cellular immunity by interferon gamma level
Immunogenicity after COVID-19 vaccination
Time frame: The second dose of vaccination
Cellular immunity by interferon gamma level
Immunogenicity after COVID-19 vaccination
Time frame: Eight weeks after the second dose of vaccination
Cellular immunity by interferon gamma level
2 secondary outcomes
rates of adverse events after vaccination
Time frame: 28 days
the incidence of COVID-19 breakthrough infection after vaccination
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 33151337Hilbrands LB, Duivenvoorden R, Vart P, Franssen CFM, Hemmelder MH, Jager KJ, Kieneker LM, Noordzij M, Pena MJ, Vries H, Arroyo D, Covic A, Crespo M, Goffin E, Islam M, Massy ZA, Montero N, Oliveira JP, Roca Munoz A, Sanchez JE, Sridharan S, Winzeler R, Gansevoort RT; ERACODA Collaborators. COVID-19-related mortality in kidney transplant and dialysis patients: results of the ERACODA collaboration. Nephrol Dial Transplant. 2020 Nov 1;35(11):1973-1983. doi: 10.1093/ndt/gfaa261.
- Background: PubMed 33708291Kengibe PY, Makulo JR, Nlandu YM, Lepira FB, Sumaili EK, Bukabau JB, Mbendi CN, Ahuka SM, Tshimpi AW, Ngoma PK, Mangani NN, Mbendi SN. Response to single dose hepatitis B vaccine in Congolese non-HIV hemodialysis patients: a prospective observational study. Pan Afr Med J. 2019 Oct 31;34:122. doi: 10.11604/pamj.2019.34.122.19603. eCollection 2019.
- Background: PubMed 34508833Bensouna I, Caudwell V, Kubab S, Acquaviva S, Pardon A, Vittoz N, Bozman DF, Hanafi L, Faucon AL, Housset P. SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis. Am J Kidney Dis. 2022 Feb;79(2):185-192.e1. doi: 10.1053/j.ajkd.2021.08.005. Epub 2021 Sep 8.
- Background: PubMed 34250319Carr EJ, Kronbichler A, Graham-Brown M, Abra G, Argyropoulos C, Harper L, Lerma EV, Suri RS, Topf J, Willicombe M, Hiremath S. Review of Early Immune Response to SARS-CoV-2 Vaccination Among Patients With CKD. Kidney Int Rep. 2021 Sep;6(9):2292-2304. doi: 10.1016/j.ekir.2021.06.027. Epub 2021 Jul 6.
- Background: PubMed 33824157Grupper A, Sharon N, Finn T, Cohen R, Israel M, Agbaria A, Rechavi Y, Schwartz IF, Schwartz D, Lellouch Y, Shashar M. Humoral Response to the Pfizer BNT162b2 Vaccine in Patients Undergoing Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2021 Jul;16(7):1037-1042. doi: 10.2215/CJN.03500321. Epub 2021 Apr 6.
- Background: PubMed 33208402Labriola L, Scohy A, Seghers F, Perlot Q, De Greef J, Desmet C, Romain C, Morelle J, Yombi JC, Kabamba B, Rodriguez-Villalobos H, Jadoul M. A Longitudinal, 3-Month Serologic Assessment of SARS-CoV-2 Infections in a Belgian Hemodialysis Facility. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):613-614. doi: 10.2215/CJN.12490720. Epub 2020 Nov 18. No abstract available.
- Background: PubMed 33931226Ikizler TA, Coates PT, Rovin BH, Ronco P. Immune response to SARS-CoV-2 infection and vaccination in patients receiving kidney replacement therapy. Kidney Int. 2021 Jun;99(6):1275-1279. doi: 10.1016/j.kint.2021.04.007. Epub 2021 Apr 20.
- Background: PubMed 33887320Torreggiani M, Blanchi S, Fois A, Fessi H, Piccoli GB. Neutralizing SARS-CoV-2 antibody response in dialysis patients after the first dose of the BNT162b2 mRNA COVID-19 vaccine: the war is far from being won. Kidney Int. 2021 Jun;99(6):1494-1496. doi: 10.1016/j.kint.2021.04.010. Epub 2021 Apr 20. No abstract available.
- Background: PubMed 32702298Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20.
- Individual participant dataSharing planned: Yes. The data that present in this study will be deposited in Mendeley osother data repository sited as appropriate
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Breakthrough Infection, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
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 5 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity after COVID-19 vaccination (time frame: Baseline before vaccination). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057936, which also lists 9 linked publications.
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 11 Jan 2022.