Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study

Abstract Background A significant decrease in antibody titres several months after COVID-19 primary vaccination in end-stage kidney disease (ESKD) patients receiving maintenance haemodialysis has recently been reported. The waning in antibody titres has led to the recommendations for a booster dose...

Full description

Bibliographic Details
Main Authors: Metalia Puspitasari, Prenali D. Sattwika, Auliana R. P. Hidayat, Wynne Wijaya, Yulia Wardhani, Umi S. Intansari, Nyoman Kertia, Bambang Purwanto, Jarir At Thobari
Format: Article
Language:English
Published: BMC 2023-05-01
Series:BMC Nephrology
Subjects:
Online Access:https://doi.org/10.1186/s12882-023-03218-x
_version_ 1797811596330795008
author Metalia Puspitasari
Prenali D. Sattwika
Auliana R. P. Hidayat
Wynne Wijaya
Yulia Wardhani
Umi S. Intansari
Nyoman Kertia
Bambang Purwanto
Jarir At Thobari
author_facet Metalia Puspitasari
Prenali D. Sattwika
Auliana R. P. Hidayat
Wynne Wijaya
Yulia Wardhani
Umi S. Intansari
Nyoman Kertia
Bambang Purwanto
Jarir At Thobari
author_sort Metalia Puspitasari
collection DOAJ
description Abstract Background A significant decrease in antibody titres several months after COVID-19 primary vaccination in end-stage kidney disease (ESKD) patients receiving maintenance haemodialysis has recently been reported. The waning in antibody titres has led to the recommendations for a booster dose to increase the antibody titres after vaccination. Consequently, it is crucial to analyse the long-term humoral immune responses after COVID-19 primary vaccination and assess the immunogenicity and safety of booster doses in haemodialysis (HD) patients. Methods Patients on maintenance haemodialysis who received the primary vaccine of CoronaVac (Sinovac) vaccine were administered with BNT162b2 (Pfizer-BioNTech) as the booster dose. The immunogenicity was assessed before (V1), one month (V2) and eight months (V3) after the primary vaccination, as well as one month after the booster dose (V4). Patients were followed up one month after the booster dose to assess the adverse events (AEs). Results The geometric mean titre (GMT) of anti-SARS-CoV-2 S-RBD IgG antibody at 8 months after the primary vaccination increased significantly to 5,296.63 (95%CI: 2,930.89–9,571.94) U/mL (p =  < 0.0001) compared to before the primary vaccination. The GMT also increased significantly to 19,142.56 (95% CI: 13,489.63–27,227.01) U/mL (p < 0.0001) 1 month after the booster vaccine. Meanwhile, the median inhibition rate of neutralizing antibodies (NAbs) at 8 months after the primary vaccine and 1 month after the booster dose were not significantly different (p > 0.9999). The most common AEs after the booster dose included mild pain at the injection site (55.26%), mild fatigue (10.53%), and swelling at the injection site (10.53%). No serious AEs were reported. Conclusions The majority of ESKD patients on haemodialysis mounted a good antibody response to the BNT162b2 booster vaccination with tolerable adverse events.
first_indexed 2024-03-13T07:25:04Z
format Article
id doaj.art-264f28df7dce470ab090c118227aa27f
institution Directory Open Access Journal
issn 1471-2369
language English
last_indexed 2024-03-13T07:25:04Z
publishDate 2023-05-01
publisher BMC
record_format Article
series BMC Nephrology
spelling doaj.art-264f28df7dce470ab090c118227aa27f2023-06-04T11:23:24ZengBMCBMC Nephrology1471-23692023-05-0124111410.1186/s12882-023-03218-xImmunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective studyMetalia Puspitasari0Prenali D. Sattwika1Auliana R. P. Hidayat2Wynne Wijaya3Yulia Wardhani4Umi S. Intansari5Nyoman Kertia6Bambang Purwanto7Jarir At Thobari8Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalDepartment of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalDepartment of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalDepartment of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalDepartment of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalDepartment of Clinical Pathology and Laboratory Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalDepartment of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalDepartment of Internal Medicine, Faculty of Medicine, Universitas Sebelas MaretClinical Epidemiology and Biostatistics Unit, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General HospitalAbstract Background A significant decrease in antibody titres several months after COVID-19 primary vaccination in end-stage kidney disease (ESKD) patients receiving maintenance haemodialysis has recently been reported. The waning in antibody titres has led to the recommendations for a booster dose to increase the antibody titres after vaccination. Consequently, it is crucial to analyse the long-term humoral immune responses after COVID-19 primary vaccination and assess the immunogenicity and safety of booster doses in haemodialysis (HD) patients. Methods Patients on maintenance haemodialysis who received the primary vaccine of CoronaVac (Sinovac) vaccine were administered with BNT162b2 (Pfizer-BioNTech) as the booster dose. The immunogenicity was assessed before (V1), one month (V2) and eight months (V3) after the primary vaccination, as well as one month after the booster dose (V4). Patients were followed up one month after the booster dose to assess the adverse events (AEs). Results The geometric mean titre (GMT) of anti-SARS-CoV-2 S-RBD IgG antibody at 8 months after the primary vaccination increased significantly to 5,296.63 (95%CI: 2,930.89–9,571.94) U/mL (p =  < 0.0001) compared to before the primary vaccination. The GMT also increased significantly to 19,142.56 (95% CI: 13,489.63–27,227.01) U/mL (p < 0.0001) 1 month after the booster vaccine. Meanwhile, the median inhibition rate of neutralizing antibodies (NAbs) at 8 months after the primary vaccine and 1 month after the booster dose were not significantly different (p > 0.9999). The most common AEs after the booster dose included mild pain at the injection site (55.26%), mild fatigue (10.53%), and swelling at the injection site (10.53%). No serious AEs were reported. Conclusions The majority of ESKD patients on haemodialysis mounted a good antibody response to the BNT162b2 booster vaccination with tolerable adverse events.https://doi.org/10.1186/s12882-023-03218-xCOVID-19 vaccinesBoosterEnd-stage renal diseaseHaemodialysisImmunogenicitySafety
spellingShingle Metalia Puspitasari
Prenali D. Sattwika
Auliana R. P. Hidayat
Wynne Wijaya
Yulia Wardhani
Umi S. Intansari
Nyoman Kertia
Bambang Purwanto
Jarir At Thobari
Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study
BMC Nephrology
COVID-19 vaccines
Booster
End-stage renal disease
Haemodialysis
Immunogenicity
Safety
title Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study
title_full Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study
title_fullStr Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study
title_full_unstemmed Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study
title_short Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study
title_sort immunogenicity and safety of covid 19 bnt162b2 booster vaccine in end stage kidney disease patients receiving haemodialysis in yogyakarta indonesia a cohort prospective study
topic COVID-19 vaccines
Booster
End-stage renal disease
Haemodialysis
Immunogenicity
Safety
url https://doi.org/10.1186/s12882-023-03218-x
work_keys_str_mv AT metaliapuspitasari immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT prenalidsattwika immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT aulianarphidayat immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT wynnewijaya immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT yuliawardhani immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT umisintansari immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT nyomankertia immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT bambangpurwanto immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy
AT jariratthobari immunogenicityandsafetyofcovid19bnt162b2boostervaccineinendstagekidneydiseasepatientsreceivinghaemodialysisinyogyakartaindonesiaacohortprospectivestudy