Antibody After COVID-19 Vaccination
Condition: Covid19; Breakthrough Infection; CKD; Kidney Transplant; Vaccination
MeSH terms: COVID-19; Breakthrough Infections
Study type: Observational

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).
    

Intervention name(s): COVID vaccine
Intervention type(s): Biological
Intervention description(s): 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
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
      
Keywords: COVID-19; vaccine; Neutralising antibody; chronic kidney disease; kidney transplant; anti-spike RBD IgG; nucleocapsid antibody; interferon gamma