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. 2023 May 30;24(1):151.
doi: 10.1186/s12882-023-03218-x.

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

Metalia Puspitasari  1 , Prenali D Sattwika  2   3   4 , Auliana R P Hidayat  2 , Wynne Wijaya  2 , Yulia Wardhani  2 , Umi S Intansari  5 , Nyoman Kertia  2 , Bambang Purwanto  6 , Jarir At Thobari  3   7
Affiliations

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

Metalia Puspitasari et al. BMC Nephrol. .

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.

Keywords: Booster; COVID-19 vaccines; End-stage renal disease; Haemodialysis; Immunogenicity; Safety.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Scatter plot showing anti-sRBD IgG titre at V1, V2, V3, and V4 (X: sampling time; Y: IgG sRBD titre)
Fig. 2
Fig. 2
Change in anti-sRBD IgG titre at V1, V2, V3, and V4 (X: sampling time; Y: IgG sRBD titre)
Fig. 3
Fig. 3
Scatter plot showing NAbs % inhibition at V1, V2, V3, and V4 (X: sampling time; Y: NAbs %inhibition)
Fig. 4
Fig. 4
Change in anti-sRBD IgG titre at V1, V2, V3, and V4 (X: sampling time; Y: NAbs %inhibition)
Fig. 5
Fig. 5
IgG sRBD ratio of V4 to V3 of symptomatic and asymptomatic haemodialysis patients
Fig. 6
Fig. 6
Local adverse events after the booster dose
Fig. 7
Fig. 7
Systemic adverse events after the booster dose
See this image and copyright information in PMC

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