Antibody After COVID-19 Vaccination
10 janvier 2022 mis à jour par: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Observationnel
Inscription (Réel)
140
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Bangkok, Thaïlande, 10300
- Faculty of Medicine,Vajira Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
CKD stage 3-5 and those require renal replacment therapy with HD,CAPD or Kidney trasnplantation
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Control
Healthy healthcare workers
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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
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Chronic kidney disease (CKD)
CKD stage 3-5 (eGFR < 60 mL/min/1.73m3)
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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
|
|
Dialysis patients
CKD stage 5 requiring HD
|
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
|
|
kidney transplant patients
patients receiving kidney transplantation for more than 3 months
|
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
|
|
dialysis patients
CKD patients requring continuos ambulatory peritoneal dialysis
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Immunogenicity after COVID-19 vaccination
Délai: Baseline before vaccination
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levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
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Baseline before vaccination
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Immunogenicity after COVID-19 vaccination
Délai: The second dose of vaccination
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levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
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The second dose of vaccination
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Immunogenicity after COVID-19 vaccination
Délai: Eight weeks after the second dose of vaccination
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levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
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Eight weeks after the second dose of vaccination
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Immunogenicity after COVID-19 vaccination
Délai: Baseline before vaccination
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Viral neutralization test measured by surrogate virus neutralization test (SVNT)
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Baseline before vaccination
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Immunogenicity after COVID-19 vaccination
Délai: The second dose of vaccination
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Viral neutralization test measured by surrogate virus neutralization test (SVNT)
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The second dose of vaccination
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Immunogenicity after COVID-19 vaccination
Délai: Eight weeks after the second dose of vaccination
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Viral neutralization test measured by surrogate virus neutralization test (SVNT)
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Eight weeks after the second dose of vaccination
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Immunogenicity after COVID-19 vaccination
Délai: Baseline before vaccination
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Cellular immunity by interferon gamma level
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Baseline before vaccination
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Immunogenicity after COVID-19 vaccination
Délai: The second dose of vaccination
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Cellular immunity by interferon gamma level
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The second dose of vaccination
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Immunogenicity after COVID-19 vaccination
Délai: Eight weeks after the second dose of vaccination
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Cellular immunity by interferon gamma level
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Eight weeks after the second dose of vaccination
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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rates of adverse events after vaccination
Délai: 28 days
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drug allergy ,skin rash,liver toxicity
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28 days
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the incidence of COVID-19 breakthrough infection after vaccination
Délai: 28 days
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number of cases that develop COVID-19 infection after vaccination
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28 days
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Folegatti 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. Erratum In: Lancet. 2020 Aug 15;396(10249):466. Lancet. 2020 Dec 12;396(10266):1884.
- 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. Erratum In: Nephrol Dial Transplant. 2021 Feb 24;:
- Kengibe 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.
- Bensouna 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.
- Carr 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.
- Grupper 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.
- Labriola 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.
- Ikizler 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.
- Torreggiani 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2021
Achèvement primaire (Réel)
31 décembre 2021
Achèvement de l'étude (Réel)
31 décembre 2021
Dates d'inscription aux études
Première soumission
23 septembre 2021
Première soumission répondant aux critères de contrôle qualité
23 septembre 2021
Première publication (Réel)
27 septembre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 janvier 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 janvier 2022
Dernière vérification
1 janvier 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 101/64
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
The data that present in this study will be deposited in Mendeley osother data repository sited as appropriate
Délai de partage IPD
after publication is accepted and indefinitely
Critères d'accès au partage IPD
additional data related to this paper may be requested from the corresponding author
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .