Antibody After COVID-19 Vaccination

January 10, 2022 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Healthy healthcare workers
Biological: 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)
Biological: 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
Biological: 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
Biological: 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
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity after COVID-19 vaccination
Time Frame: Baseline before vaccination
levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Time Frame: 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
Time Frame: 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
Time Frame: Baseline before vaccination
Viral neutralization test measured by surrogate virus neutralization test (SVNT)
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Time Frame: 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
Time Frame: 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
Time Frame: Baseline before vaccination
Cellular immunity by interferon gamma level
Baseline before vaccination
Immunogenicity after COVID-19 vaccination
Time Frame: The second dose of vaccination
Cellular immunity by interferon gamma level
The second dose of vaccination
Immunogenicity after COVID-19 vaccination
Time Frame: Eight weeks after the second dose of 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
Time Frame: 28 days
drug allergy ,skin rash,liver toxicity
28 days
the incidence of COVID-19 breakthrough infection after vaccination
Time Frame: 28 days
number of cases that develop COVID-19 infection after vaccination
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101/64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

after publication is accepted and indefinitely

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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