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Patients with chronic kidney disease (CKD) in dialysis are a population at risk for hepatitis B (HB) virus infection, with its vaccination being a primary objective in this group of patients. However, the immune response in CKD is poor, leading to lower rates of seroconversion, with lower HB surface antibody (HBsAb) titers and of shorter duration compared to the general population.
The HB vaccine is traditionally administered by intramuscular (IM) route. In individuals with HBsAb titers < 10 mlIU/ml (non-responders) after the first series of vaccines, three additional doses are recommended to complete a second series with a similar vaccine. However, there is no consensus about what to do after two series of vaccination without response. One strategy is to use the intradermal (ID) route, which activates an immune response mediated by dendritic cells, requiring a lower dose of antigen than the standard IM route.
Since 2012, the ID vaccination schedule has been implemented in our center as an alternative to IM vaccination in non-responders patients.
The aim of this study was to evaluate the response to ID HB vaccination in patients with CKD in dialysis who did not respond to IM HB vaccination.
A descriptive, retrospective and observational study was conducted with patients on hemodialysis (HD) and peritoneal dialysis (PD) in a center in the Province of Buenos Aires between June 2012 and January 2023. Data were obtained from electronic medical records.
All patients had completed at least one IM series of vaccines, with HBsAb titers < 10 mlUI/ml, which was considered as non response. Other viral infections were excluded.
A total of 6 doses of 20 mcg/ml of HB vaccine was given ID, 2 weeks apart.
Variables such as age, sex, dialysis modality, time on dialysis, history of diabetes mellitus (DBT), previous series of vaccines and time to control were analyzed. In the responders, the persistence of HBsAb titers over time was also analyzed.
Continuous variables are presented as median and interquartile range (IQR 25-75) due to their distribution, and categorical variables as nominal and percentages. The statistical analysis was made with R. Multivariate logistic regression analyses was performed in search of predictors of response to the ID route. A p value less than 0.05 was considered statistically significant.
ID vaccination was indicated in 61 patients, but 18 were excluded due to incomplete scheme or lack of control: in 43 patients analyzed, an adequate immune response was obtained in 26 of them (60%). The median time to control was 8 months (IQR 25-75, 6-9). No statistically significant differences were observed between responders and non-responders in terms of age, sex, DBT, time on dialysis and dialysis modality (Table 1).
In 16 of 26 responders patients (61.5%), HBsAb titers were controlled over time, and in all cases were > 10 mlIU/ml. The follow-up range was 9 and 102 months. The median duration of protective titers in responders was 28 months (IQR 25-75, 23-44.5).
In the multivariate logistic regression analysis, no predictor variables were found that were associated with the group of patients responding to the ID vaccination, which could be attributed to the sample size.
ID vaccination should be considered in dialysis patients without response to IM HB vaccination as it generates an acceptable and persistent response over time, regardless of sex, age, time on dialysis and comorbidities such as DBT.