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Antibody After COVID-19 Vaccination

10 de enero de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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 de estudio

De observación

Inscripción (Actual)

140

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Control
Healthy healthcare workers
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)
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Immunogenicity after COVID-19 vaccination
Periodo de tiempo: Baseline before vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline before vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline before vaccination
Cellular immunity by interferon gamma level
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Periodo de tiempo: The second dose of vaccination
Cellular immunity by interferon gamma level
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
Periodo de tiempo: Eight weeks after the second dose of vaccination
Cellular immunity by interferon gamma level
Eight weeks after the second dose of vaccination

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
rates of adverse events after vaccination
Periodo de tiempo: 28 days
drug allergy ,skin rash,liver toxicity
28 days
the incidence of COVID-19 breakthrough infection after vaccination
Periodo de tiempo: 28 days
number of cases that develop COVID-19 infection after vaccination
28 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2021

Finalización primaria (Actual)

31 de diciembre de 2021

Finalización del estudio (Actual)

31 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

23 de septiembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

23 de septiembre de 2021

Publicado por primera vez (Actual)

27 de septiembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de enero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

10 de enero de 2022

Última verificación

1 de enero de 2022

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

after publication is accepted and indefinitely

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre COVID-19

Ensayos clínicos sobre COVID vaccine

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