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Antibody After COVID-19 Vaccination

10 gennaio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Osservativo

Iscrizione (Effettivo)

140

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Tailandia
      • Bangkok, Tailandia, 10300
        • Faculty of Medicine,Vajira Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

CKD stage 3-5 and those require renal replacment therapy with HD,CAPD or Kidney trasnplantation

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Control
Healthy healthcare workers
Biologico: COVID vaccine
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
Chronic kidney disease (CKD)
CKD stage 3-5 (eGFR < 60 mL/min/1.73m3)
Biologico: COVID vaccine
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
Biologico: COVID vaccine
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
Biologico: COVID vaccine
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
Biologico: COVID vaccine
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Immunogenicity after COVID-19 vaccination
Lasso di tempo: Baseline before vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: The second dose of vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: Eight weeks after the second dose of vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Eight weeks after the second dose of vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: Baseline before vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: The second dose of vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: Eight weeks after the second dose of vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Eight weeks after the second dose of vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: Baseline before vaccination
Cellular immunity by interferon gamma level
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: The second dose of vaccination
Cellular immunity by interferon gamma level
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
Lasso di tempo: Eight weeks after the second dose of vaccination
Cellular immunity by interferon gamma level
Eight weeks after the second dose of vaccination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
rates of adverse events after vaccination
Lasso di tempo: 28 days
drug allergy ,skin rash,liver toxicity
28 days
the incidence of COVID-19 breakthrough infection after vaccination
Lasso di tempo: 28 days
number of cases that develop COVID-19 infection after vaccination
28 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2021

Completamento primario (Effettivo)

31 dicembre 2021

Completamento dello studio (Effettivo)

31 dicembre 2021

Date di iscrizione allo studio

Primo inviato

23 settembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

23 settembre 2021

Primo Inserito (Effettivo)

27 settembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 gennaio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 gennaio 2022

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 101/64

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data that present in this study will be deposited in Mendeley osother data repository sited as appropriate

Periodo di condivisione IPD

after publication is accepted and indefinitely

Criteri di accesso alla condivisione IPD

additional data related to this paper may be requested from the corresponding author

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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