Incidence of adverse events of the Covid-19 vaccine in a population of kidney transplant recipients

Introducción: Early published series suggest that most renal transplant recipients remain at high risk of SARS-CoV-2 infection due to poor humoral response after vaccination. The aim was to study the occurrence of adverse events after two doses of mRNA-1273 vaccine in a population of renal transplant recipients. Material and Method: Analytical, observational, and prospective study. Subjects were injected with two doses of mRNA-1273 vaccine against SARS-CoV-2 according to the schedule established by the laboratory. After injection of each dose, and up to 72 hours later, participants recorded local and/or systemic symptoms and their intensity. Results: 187 patients were included. Eighteen percent of them became infected with SARS-CoV-2 in the pre-vaccination period or between the 1st and 2nd dose. The incidence of adverse events was 91.2%. Of these, the incidence of local (62%) was higher than that of systemic (55%). Past infection was a risk factor for the occurrence of local adverse events after vaccination (OR= 2.4; p=0.045). The same association was detected for systemic adverse events, which were more frequent among those who had passed the disease (OR=3.83; p=0.003). Conclusions: The mRNA-1273 vaccine does not appear to cause serious side effects. The incidence of local and systemic adverse events was higher in those patients with past disease

{'en_US': 'Incidence of SARS-CoV-2 infection in patients with a functioning renal transplant in a tertiary hospital in the community of Madrid', 'es_ES': 'Incidencia de infección por SARS-CoV-2 en pacientes con un trasplante renal funcionante de un hospital terciario de la Comunidad de Madrid'}

En diciembre de 2019, apareció un nuevo coronavirus que ha dado lugar a una pandemia. Dadas las características del paciente trasplantado, se hace necesario conocer cuál ha sido la repercusión respecto a la infección por SARS-CoV-2, planteándonos como objetivo describir la incidencia de SARS-CoV-2 en pacientes con un trasplante renal. Se llevó a cabo un estudio observacional de cohorte retrospectiva de pacientes con un trasplante renal y que están en seguimiento por la consulta de trasplantes de un hospital terciario, durante el periodo comprendido entre el 1 de marzo de 2020 y el 1 de marzo de 2021. Se incluyeron 604 individuos, con una edad media de 61,6±12,8 años. Un 62,3% (n=376) fueron hombres. La incidencia por SARS-CoV-2 fue 14,9% (n=90). La mortalidad por SARS-CoV-2 fue 3,8% (n=23) lo que supone una letalidad del 25,5%. Al comparar si han pasado la infección en función del sexo no se encontraron diferencias significativas. Tampoco al comparar en función de la edad media, que fue de 60,9±11,8 años en los infectados y de 61,7±12,9 años en los no infectados. Se encontraron diferencias significativas (p=0,005) al comparar la media de años transcurridos desde el trasplante; que fue de 8,7±5,6 años en los infectados y de 11±7,3 años en los no infectados. La incidencia de infección por SARS-CoV-2 encontrada en personas con TR fue muy superior a la descrita para la población general. La letalidad y la mortalidad también fueron mayores que en la población general, pero acordes con otras poblaciones de individuos con TR

Development of an Information Guideline for Kidney Transplant Recipients in a Clinical Trial: Protocol for a Modified Delphi Method

BackgroundRenal transplantation is the treatment of choice for most cases of end-stage renal disease. Recipients need to lead a healthy lifestyle to minimize the potential side effects of immunosuppressive drugs and improve transplant outcomes. There is not much evidence about the best way to increase adherence to healthy lifestyles in kidney transplant recipients, so one of the objectives set by the nursing team is to train people to acquire the necessary skills and tools to be able to take care of themselves. In this sense, the consensual development of appropriate materials may be useful and of interest. ObjectiveThe aim of this study was to develop an information guide for adults with kidney transplants to be assessed in a subsequent clinical trial as an intervention to increase adherence to healthy habits. MethodsWe used a 3-step, methodological, sequential approach: (1) training from a group of experts and item consensus; (2) review of the medical literature available; and (3) use of the Delphi technique with on-site meetings. A total of 5 nurses from the Community of Madrid Kidney Transplantation Unit in Spain were asked to participate. The patients’ lifestyle factors that, according to the medical literature available and experts’ opinions, have the greatest impact on the survival of the transplanted organ and the recipients themselves were all described. ResultsAfter using the modified Delphi method to reach a consensus on the items to be included and the information needed in each, an information guide for adult kidney transplant patients was developed. This guide facilitates the structuring of health care, information, and recommendations necessary for effective self-care for each person. The result is considered to be an easy-to-understand tool, useful for transplant doctors and nurses, in simple language, with information based on the latest scientific-medical evidence published to date, aspects of which will be evaluated in a clinical trial designed for this purpose. ConclusionsCurrently, this guide is the main intervention variable of a clinical trial (registered on ClinicalTrials.gov; NCT05715580) aimed at improving compliance with healthy habits in kidney transplant recipients in the Community of Madrid, Spain. The method used in its development has been useful and agile, and the result is a guide that can be easily updated periodically following the same procedure. International Registered Report Identifier (IRRID)DERR1-10.2196/4696

Role of mTOR inhibitor in the cellular and humoral immune response to a booster dose of SARS-CoV-2 mRNA-1273 vaccine in kidney transplant recipients

Background: Immunocompromised patients have an increased risk of developing severe COVID disease, as well as a tendency to suboptimal responses to vaccines. The objective of this study was to evaluate the specific cellular and humoral adaptive immune responses of a cohort of kidney transplant recipients (KTR) after 3 doses of mRNA-1273 vaccine and to determinate the main factors involved. Methods: Prospective observational study in 221 KTR (149 non infected), 55 healthy volunteers (HV) and 23 dialysis patients (DP). We evaluated anti-spike (by quantitative chemiluminescence immunoassay) and anti-nucleocapsid IgG (ELISA), percentage of TCD4+ and TCD8+ lymphocytes producing IFNγ against S-protein by intracellular flow cytometry after Spike-specific 15-mer peptide stimulation and serum neutralizing activity (competitive ELISA) at baseline and after vaccination. Results: Among COVID-19 naïve KTR, 54.2% developed cellular and humoral response after the third dose (vs 100% in DP and 91.7% in HV), 18% only showed cell-mediated response, 22.2% exclusively antibody response and 5.6% none. A correlation of neutralizing activity with both the IgG titer (r=0.485, p1000/mm3 [4.68 (1.72-12.73, p=0.003], eGFR>30 mL/min [7.34(2.72-19.84), p<0.001], mTOR inhibitors [6.40 (1.37-29.86), p=0.018]. Infected KTR developed a stronger serologic response than naïve patients (96.8 vs 75.2%, p<0.001). Conclusions: KTR presented poor cellular and humoral immune responses following vaccination with mRNA-1273. The immunosuppression degree and kidney function of these patients play an important role, but the only modifiable factor with a high impact on humoral immunogenicity after a booster dose was an immunosuppressive therapy including a mTOR inhibitor. Clinical trials are required to confirm these results.Depto. de Inmunología, Oftalmología y ORLFac. de MedicinaTRUEpu