Antibody After COVID-19 Vaccination

Study Overview
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Brief Summary
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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
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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).

Official Title
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Antibody Response After COVID-19 Vaccination in Chronic Kidney Disease and Kidney Transplant Patients

Conditions
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Covid19, Breakthrough Infection, CKD, Kidney Transplant, Vaccination

Intervention / Treatment
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* Biological: COVID vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Healthy healthcare workers | Biological: COVID vaccine<br>* 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<br>|
| Chronic kidney disease (CKD)<br>CKD stage 3-5 (eGFR < 60 mL/min/1.73m3) | Biological: COVID vaccine<br>* 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<br>|
| Dialysis patients<br>CKD stage 5 requiring HD | Biological: COVID vaccine<br>* 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<br>|
| kidney transplant patients<br>patients receiving kidney transplantation for more than 3 months | Biological: COVID vaccine<br>* 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<br>|
| dialysis patients<br>CKD patients requring continuos ambulatory peritoneal dialysis | Biological: COVID vaccine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity after COVID-19 vaccination | levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration | Baseline before vaccination | 
| Immunogenicity after COVID-19 vaccination | levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration | The second dose of vaccination | 
| Immunogenicity after COVID-19 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 | Viral neutralization test measured by surrogate virus neutralization test (SVNT) | Baseline before vaccination | 
| Immunogenicity after COVID-19 vaccination | Viral neutralization test measured by surrogate virus neutralization test (SVNT) | The second dose of vaccination | 
| Immunogenicity after COVID-19 vaccination | Viral neutralization test measured by surrogate virus neutralization test (SVNT) | Eight weeks after the second dose of vaccination | 
| Immunogenicity after COVID-19 vaccination | Cellular immunity by interferon gamma level | Baseline before vaccination | 
| Immunogenicity after COVID-19 vaccination | Cellular immunity by interferon gamma level | The second dose of vaccination | 
| Immunogenicity after COVID-19 vaccination | Cellular immunity by interferon gamma level | Eight weeks after the second dose of vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of adverse events after vaccination | drug allergy ,skin rash,liver toxicity | 28 days | 
| the incidence of COVID-19 breakthrough infection after vaccination | number of cases that develop COVID-19 infection after vaccination | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, vaccine, Neutralising antibody, chronic kidney disease, kidney transplant, anti-spike RBD IgG, nucleocapsid antibody, interferon gamma