key: cord-1020878-3xoos2z9
authors: Medina-Pestana, José; Teixeira, Cinthia Montenegro; Cristelli, Marina Pontello; Amiratti, Adriano Luiz; Manfredi, Silvia Regina; Tedesco-Silva, Helio; Covas, Dimas Tadeu
title: Clinical impact, reactogenicity and immunogenicity after the first CoronaVac dose in dialysis patients: a Phase IV prospective study
date: 2021-08-17
journal: Clin Kidney J
DOI: 10.1093/ckj/sfab146
sha: 5d382269ea39934bf29de121c702836861d60907
doc_id: 1020878
cord_uid: 3xoos2z9

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The characteristics and outcomes of the study population (n ¼ 198) are shown in Table 1 . They were predominantly male, with a median age of 50 years [interquartile range (IQR) 40-56], diabetes mellitus in 21% and a median time on dialysis of 32 months (IQR 15-63).

The prevalence of anti-SARS-CoV-2 nucleocapsid protein on Day 0 was 27% (n ¼ 54). For immunogenicity analysis, 137 patients who were seronegative for IgG anti-SARS-CoV-2 were included (56 had either positive IgG at Day 0 or a previous confirmed COVID-19 diagnosis and 5 had no serologic test available). Seroconversion 28 days after the first dose was 44% [95% confidence interval (CI) 36-53] with a median IgG value of 40 AU/mL (IQR 12-95) ( Figure 1 ). Among those who were IgG positive, the median IgG value was 99 AU/mL (IQR 90-143). Patients >45 years of age and those on chronic-use prednisone 5 mg/day for failed renal allografts showed a lower seroconversion rate.

After the first vaccine dose, 4 (2%) patients had a COVID-19 diagnosis confirmed byreverse transcription polymerase chain reaction or antigen test at a median time of 14 days (IQR 11-15). Of these, two required hospitalization and one died 42 days after the first dose of the vaccine.

The most common adverse reaction after the first dose was local pain/tenderness (16%). Systemic symptoms (fever, myalgia, headache and diarrhea) occurred in 8% of the patients and no severe adverse reactions were observed. In this ongoing prospective study, the first dose of CoronaVac vaccine was safe for dialysis patients, with a few mild adverse events. The seroconversion rate after the first dose was lower than that reported among healthcare workers receiving CoronaVac [3] but was similar to that of other studies with dialysis patients and messenger RNA (mRNA) vaccines [4] . Older age and the use of low-dose maintenance prednisone after a failed transplant were associated with a lower antibody response. These factors also impair the immunologic response to other vaccines, such as hepatitis B, in this population [5] . The small number of events and the short follow-up time prevent drawing any conclusions about the clinical effectiveness of the first dose of the vaccine.

In conclusion, our preliminary results are in agreement with previously published studies of mRNA vaccines, indicating a lower seroconversion rate among patients on renal replacement therapy. This reinforces the urgent need to maintain sanitary measures for individual protection and promote vaccination of household contacts and caregivers. Furthermore, it suggests that other immunization strategies, perhaps with higher or additional doses, or even the combination of vaccines developed using different platforms, deserve to be studied in this group of individuals. 

The authors declare no conflicts of interest. CoV-2 vaccine (n ¼ 137). Abbott AdviseDx SARS-CoV-2 IgG II immunoassay for total IgG antibodies against the receptor-binding domain of the S1 subunit of the SARS-CoV-2 spike protein, in logarithmic scale. The lowest limit of detection, as per the manufacturer, is 6.8 AU/mL (0.83 log). The analytical measuring interval is 21-40 000 AU/mL. Twenty participants had undetectable values. Orange dots represent the 26 participants who had detectable values, but below the analytic limit (6.8-21 AU/mL). Light blue dots represent the 31 participants who had values above the analytic limit (>21 AU/mL or 1.32 log) but under the threshold for considering the test as positive (50 AU/mL or 1.69 log; dotted line). Green dots represent the 60 participants who tested positive for IgG antibodies.

Effectiveness of an inactivated SARS-CoV-2 vaccine in Chile

Results from the ERA-EDTA Registry indicate a high mortality due to COVID-19 in dialysis patients and kidney transplant recipients across Europe

Efficacy and safety of a COVID-19 inactivated vaccine in healthcare professionals in Brazil: the PROFISCOV Study

Humoral response to the Pfizer BNT162b2 vaccine in patients undergoing maintenance hemodialysis

Hepatitis B vaccination in haemodialysis patients: an underestimated problem. Factors influencing immune responses in ten years of observation in an Italian haemodialysis centre and literature review

This work would not have been possible without the provision of the vaccines, coordinated by Ricardo Palacios and Roberta Piorelli from Instituto Butantan, the efforts of the haemodialysis and peritoneal dialysis team led by Maria Claudia Cruz Andreoli and Camila Barbosa Silva Barros, the organization for the vaccination of patients led by Monica Rika Nakamura and Marcia Toffoli and the valuable contribution of our biochemist Elizabeth França Lucena, who conducted all the laboratory analysis.

Due to ethical concerns, supporting data can only be made available to bona fide researchers subject to a non-disclosure agreement.