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NCT Number: NCT05057936

Antibody After COVID-19 Vaccination

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.

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Key information

Conditions

Covid19 Breakthrough Infection Breakthrough Infections CKD COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Kidney Transplant Lung Diseases Male Urogenital Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Vaccination Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine,Vajira Hospital

Bangkok, 10300, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID vaccine

Biological

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

Primary outcomes

  1. Immunogenicity after COVID-19 vaccination

    Time frame: Baseline before vaccination

    levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration

  2. Immunogenicity after COVID-19 vaccination

    Time frame: The second dose of vaccination

    levels of SARS-CoV2 spike S1-specific immunoglobulin (IgG) antibody concentration

  3. 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

  4. Immunogenicity after COVID-19 vaccination

    Time frame: Baseline before vaccination

    Viral neutralization test measured by surrogate virus neutralization test (SVNT)

  5. Immunogenicity after COVID-19 vaccination

    Time frame: The second dose of vaccination

    Viral neutralization test measured by surrogate virus neutralization test (SVNT)

  6. 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)

  7. Immunogenicity after COVID-19 vaccination

    Time frame: Baseline before vaccination

    Cellular immunity by interferon gamma level

  8. Immunogenicity after COVID-19 vaccination

    Time frame: The second dose of vaccination

    Cellular immunity by interferon gamma level

  9. Immunogenicity after COVID-19 vaccination

    Time frame: Eight weeks after the second dose of vaccination

    Cellular immunity by interferon gamma level

Secondary outcomes

  1. rates of adverse events after vaccination

    Time frame: 28 days

    drug allergy ,skin rash,liver toxicity

  2. the incidence of COVID-19 breakthrough infection after vaccination

    Time frame: 28 days

    number of cases that develop COVID-19 infection after vaccination

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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