Antibody After COVID-19 Vaccination

NCT05057936 | Completed DMC

• 1 other identifier: 101/64
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• rates of adverse events after vaccination

  28 days

• the incidence of COVID-19 breakthrough infection after vaccination

  28 days

Study Arms (5)

Control

Healthy healthcare workers

Biological: COVID vaccine

Chronic kidney disease (CKD)

CKD stage 3-5 (eGFR \< 60 mL/min/1.73m3)

Biological: COVID vaccine

Dialysis patients

CKD stage 5 requiring HD

Biological: COVID vaccine

kidney transplant patients

patients receiving kidney transplantation for more than 3 months

Biological: COVID vaccine

dialysis patients

CKD patients requring continuos ambulatory peritoneal dialysis

Biological: COVID vaccine

Interventions

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

Chronic kidney disease (CKD); Control; Dialysis patients; dialysis patients; kidney transplant patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Faculty of Medicine,Vajira Hospital

Bangkok, 10300, Thailand

Location

Related Publications (9)

• Hilbrands LB, Duivenvoorden R, Vart P, Franssen CFM, Hemmelder MH, Jager KJ, Kieneker LM, Noordzij M, Pena MJ, Vries H, Arroyo D, Covic A, Crespo M, Goffin E, Islam M, Massy ZA, Montero N, Oliveira JP, Roca Munoz A, Sanchez JE, Sridharan S, Winzeler R, Gansevoort RT; ERACODA Collaborators. COVID-19-related mortality in kidney transplant and dialysis patients: results of the ERACODA collaboration. Nephrol Dial Transplant. 2020 Nov 1;35(11):1973-1983. doi: 10.1093/ndt/gfaa261.

  PMID: 33151337 BACKGROUND

• Kengibe PY, Makulo JR, Nlandu YM, Lepira FB, Sumaili EK, Bukabau JB, Mbendi CN, Ahuka SM, Tshimpi AW, Ngoma PK, Mangani NN, Mbendi SN. Response to single dose hepatitis B vaccine in Congolese non-HIV hemodialysis patients: a prospective observational study. Pan Afr Med J. 2019 Oct 31;34:122. doi: 10.11604/pamj.2019.34.122.19603. eCollection 2019.

  PMID: 33708291 BACKGROUND

• Bensouna I, Caudwell V, Kubab S, Acquaviva S, Pardon A, Vittoz N, Bozman DF, Hanafi L, Faucon AL, Housset P. SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis. Am J Kidney Dis. 2022 Feb;79(2):185-192.e1. doi: 10.1053/j.ajkd.2021.08.005. Epub 2021 Sep 8.

  PMID: 34508833 BACKGROUND

• Carr EJ, Kronbichler A, Graham-Brown M, Abra G, Argyropoulos C, Harper L, Lerma EV, Suri RS, Topf J, Willicombe M, Hiremath S. Review of Early Immune Response to SARS-CoV-2 Vaccination Among Patients With CKD. Kidney Int Rep. 2021 Sep;6(9):2292-2304. doi: 10.1016/j.ekir.2021.06.027. Epub 2021 Jul 6.

  PMID: 34250319 BACKGROUND

• Grupper A, Sharon N, Finn T, Cohen R, Israel M, Agbaria A, Rechavi Y, Schwartz IF, Schwartz D, Lellouch Y, Shashar M. Humoral Response to the Pfizer BNT162b2 Vaccine in Patients Undergoing Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2021 Jul;16(7):1037-1042. doi: 10.2215/CJN.03500321. Epub 2021 Apr 6.

  PMID: 33824157 BACKGROUND

• Labriola L, Scohy A, Seghers F, Perlot Q, De Greef J, Desmet C, Romain C, Morelle J, Yombi JC, Kabamba B, Rodriguez-Villalobos H, Jadoul M. A Longitudinal, 3-Month Serologic Assessment of SARS-CoV-2 Infections in a Belgian Hemodialysis Facility. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):613-614. doi: 10.2215/CJN.12490720. Epub 2020 Nov 18. No abstract available.

  PMID: 33208402 BACKGROUND

• Ikizler TA, Coates PT, Rovin BH, Ronco P. Immune response to SARS-CoV-2 infection and vaccination in patients receiving kidney replacement therapy. Kidney Int. 2021 Jun;99(6):1275-1279. doi: 10.1016/j.kint.2021.04.007. Epub 2021 Apr 20.

  PMID: 33931226 BACKGROUND

• Torreggiani M, Blanchi S, Fois A, Fessi H, Piccoli GB. Neutralizing SARS-CoV-2 antibody response in dialysis patients after the first dose of the BNT162b2 mRNA COVID-19 vaccine: the war is far from being won. Kidney Int. 2021 Jun;99(6):1494-1496. doi: 10.1016/j.kint.2021.04.010. Epub 2021 Apr 20. No abstract available.

  PMID: 33887320 BACKGROUND

• Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20.

  PMID: 32702298 BACKGROUND

MeSH Terms

Conditions

COVID-19; Breakthrough Infections; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: September 27, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication is accepted and indefinitely
• Access Criteria: additional data related to this paper may be requested from the corresponding author

Locations

TH (1)