Clinical trial NCT05057936: Antibody After COVID-19 Vaccination
Official title: Antibody Response After COVID-19 Vaccination in Chronic Kidney Disease and Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2021-09-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD stage 3-5 and those require renal replacment therapy with HD,CAPD or Kidney trasnplantation

Brief 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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Immunogenicity after COVID-19 vaccination
timeFrame: Baseline before vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: The second dose of vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: Eight weeks after the second dose of vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: Baseline before vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: The second dose of vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: Eight weeks after the second dose of vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: Baseline before vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: The second dose of vaccination
measure: Immunogenicity after COVID-19 vaccination
timeFrame: Eight weeks after the second dose of vaccination
Secondary outcomes:
measure: rates of adverse events after vaccination
timeFrame: 28 days
measure: the incidence of COVID-19 breakthrough infection after vaccination
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine,Vajira Hospital
Study officials:
References:
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