Real-world evaluation of a QCM-based biosensor for exhaled air.

The biosensor, named "virusmeter" in this study, integrates quartz crystal microbalance technology with an immune-functionalized chip to distinguish between symptomatic patients with respiratory diseases and healthy individuals by analyzing exhaled air samples. Renowned for its compact design, rapidity, and noninvasive nature, this device yields results within a 5-min timeframe. Evaluated under controlled conditions with 54 hospitalized symptomatic COVID-19 patients and 128 control subjects, the biosensor demonstrated good overall sensitivity (98.15%, 95% CI 90.1-100.0) and specificity (96.87%, 95% CI 92.2-99.1). This proof-of-concept presents an innovative approach with significant potential for leveraging piezoelectric sensors to diagnose respiratory diseases.

Early estimates of nirsevimab immunoprophylaxis effectiveness against hospital admission for respiratory syncytial virus lower respiratory tract infections in infants, Spain, October 2023 to January 2024.

The monoclonal antibody nirsevimab was at least 70% effective in preventing hospitalisations in infants with lower respiratory tract infections (LRTI) positive for respiratory syncytial virus (RSV) in Spain (Oct 2023-Jan 2024), where a universal immunisation programme began late September (coverage range: 79-99%). High protection was confirmed by two methodological designs (screening and test-negative) in a multicentre active surveillance in nine hospitals in three regions. No protection against RSV-negative LRTI-hospitalisations was shown. These interim results could guide public-health decision-making.

Influenza vaccine effectiveness against laboratory-confirmed influenza in hospitalised adults aged 60 years or older, Valencia Region, Spain, 2017/18 influenza season.

IntroductionInfluenza immunisation is recommended for elderly people each season. The influenza vaccine effectiveness (IVE) varies annually due to influenza viruses evolving and the vaccine composition.AimTo estimate, in inpatients ≥ 60 years old, the 2017/18 trivalent IVE, overall, by vaccine type and by strain. The impact of vaccination in any of the two previous seasons (2016/17 and 2015/16) on current (2017/18) IVE was also explored.MethodsThis was a multicentre prospective observational study within the Valencia Hospital Surveillance Network for the Study of Influenza and Respiratory Viruses Disease (VAHNSI, Spain). The test-negative design was applied taking laboratory-confirmed influenza as outcome and vaccination status as main exposure. Information about potential confounders was obtained from clinical registries and/or by interviewing patients; vaccine information was only ascertained by registries.ResultsOverall, 2017/18 IVE was 9.9% (95% CI: -15.5 to 29.6%), and specifically, 48.3% (95% CI: 13.5% to 69.1%), -29.9% (95% CI: -79.1% to 5.8%) and 25.7% (95% CI: -8.8% to 49.3%) against A(H1N1)pdm09, A(H3N2) and B/Yamagata lineage, respectively. For the adjuvanted and non-adjuvanted vaccines, overall IVE was 10.0% (95% CI: -24.4% to 34.9%) and 7.8% (95% CI: -23.1% to 31.0%) respectively. Prior vaccination significantly protected against influenza B/Yamagata lineage (IVE: 50.2%; 95% CI: 2.3% to 74.6%) in patients not vaccinated in the current season. For those repeatedly vaccinated against influenza A(H1N1)pdm09, IVE was 46.4% (95% CI: 6.8% to 69.2%).ConclusionOur data revealed low vaccine effectiveness against influenza in hospitalised patients ≥60 years old in 2017/18. Prior vaccination protected against influenza A(H1N1)pdm09 and B/Yamagata-lineage.

Influenza vaccine effectiveness in preventing hospitalisation of individuals 60 years of age and over with laboratory-confirmed influenza, Valencia Region, Spain, influenza season 2016/17.

IntroductionSeasonal influenza vaccination is widely recommended for people with risk factors, especially for people who are elderly. However, influenza vaccine effectiveness (IVE) varies year after year because of the variable antigenic composition of the circulating viruses and the vaccine composition. Methods: We summarise the results of IVE and the impact of previous vaccination among subjects 60 years of age and over in a multicentre prospective study in the Valencia Hospital Surveillance Network for the Study of Influenza and Respiratory Viruses Disease (VAHNSI) in Spain. We applied the test-negative design taking laboratory-confirmed influenza as outcome and vaccination status as exposure. Information about potential confounders was obtained from clinical registries or directly from patients. Results: Adjusted IVE was 19% (95% confidence interval (CI): -15 to 43). For patients vaccinated in the current season but not in the two previous seasons, effectiveness was 49% (95% CI: -20 to 78) and for patients vaccinated in the current and any of two previous seasons, effectiveness was 29% (95% CI: -3 to 52). For those patients not vaccinated in the current season but vaccinated in any of the two previous seasons, effectiveness was 53% (95% CI: 8 to 76). Conclusions: Our data show a low vaccine effectiveness for the 2016/17 influenza season.

Retrospective screening for SARS-CoV-2 among influenza-like illness hospitalizations: 2018-2019 and 2019-2020 seasons, Valencia region, Spain.

On 9 March 2020, the World Health Organization (WHO) Global Influenza Programme (GIP) asked participant sites on the Global Influenza Hospital Surveillance Network (GIHSN) to contribute to data collection concerning severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We re-analysed 5833 viral RNA archived samples collected prospectively from hospital admissions for influenza-like illness (ILI) in the Valencia Region of Spain by the Valencia Hospital Surveillance Network for the Study of Influenza and Other Respiratory Viruses (VAHNSI) network (four hospitals, catchment area population 1 118 732) during the pre-pandemic 2018/2019 (n = 4010) and pandemic 2019/2020 (n = 1823) influenza seasons for the presence of SARS-CoV-2. We did not find evidence for community-acquired SARS-CoV-2 infection in hospital admissions for ILI in our region before early March 2020.

Role of age and birth month in infants hospitalized with RSV-confirmed disease in the Valencia Region, Spain.

BACKGROUND: RSV is the leading cause of hospital admissions in infants and the principal cause of bronchiolitis in young children. There is a lack of granular data on RSV-associated hospitalization per season using laboratory confirmed results. Our current study addresses this issue and intends to fill this gap. METHODS: The study was conducted from 2014 through 2018, in 4 to 10 hospitals in the Valencia Region, Spain. Infants included in this study were admitted in hospital through the Emergency Department with a respiratory complaint and tested by RT-PCR for RSV in a central laboratory. RESULTS: Incidence rates of RSV-associated hospitalization varied by season and hospital. Overall, the highest incidence rates were observed in 2017/2018. RSV-associated hospitalization was highest in infants below 3 months of age and in those born before or at the beginning of the RSV season. Almost 54% of total infants hospitalized with laboratory confirmed RSV were found to be born outside the season, from April to October. The RSV positivity rate by ICD-10 discharged codes varied by season and age with results from 48% to 57% among LRI (J09-J22). CONCLUSION: The study was instrumental in bringing forth the time unpredictability of RSV epidemics, the critical impact of age, and the comparable distribution of RSV-associated hospitalization in infants born on either side of the RSV season. These data could help in better characterization of the population that drives the healthcare burden and is crucial for the development of future immunization strategies, especially with upcoming vaccines in against RSV.

Influenza Vaccine Effectiveness and Waning Effect in Hospitalized Older Adults. Valencia Region, Spain, 2018/2019 Season.

Influenza vaccination is annually recommended for specific populations at risk, such as older adults. We estimated the 2018/2019 influenza vaccine effectiveness (IVE) overall, by influenza subtype, type of vaccine, and by time elapsed since vaccination among subjects 65 years old or over in a multicenter prospective study in the Valencia Hospital Surveillance Network for the Study of Influenza and other Respiratory Viruses (VAHNSI, Spain). Information about potential confounders was obtained from clinical registries and/or by interviewing patients and vaccination details were only ascertained by registries. A test-negative design was performed in order to estimate IVE. As a result, IVE was estimated at 46% (95% confidence interval (CI): (16%, 66%)), 41% (95% CI: (-34%, 74%)), and 45% (95% CI: (7%, 67%)) against overall influenza, A(H1N1)pdm09 and A(H3N2), respectively. An intra-seasonal not relevant waning effect was detected. The IVE for the adjuvanted vaccine in ≥75 years old was 45% (2%, 69%) and for the non-adjuvanted vaccine in 65-74 years old was 59% (-16%, 86%). Thus, our data revealed moderate vaccine effectiveness against influenza A(H3N2) and not significant against A(H1N1)pdm09. Significant protection was conferred by the adjuvanted vaccine to patients ≥75 years old. Moreover, an intra-seasonal not relevant waning effect was detected, and a not significant IVE decreasing trend was observed over time.

[Vaccine response to SARS-CoV-2 in hospital workers]. / Respuesta vacunal frente a SARS-CoV-2 en trabajadores de un hospital.

INTRODUCTION: The aim of this study was to measure anti-SARS-CoV-2 immunity of hospital workers after a completed 2-dose Pfizer-BionTech vaccination, and to examine factors potentially associated with immunity status. Side effects of the vaccine were also studied. METHOD: This was a cross-sectional study of a representative sample of General University Hospital of Castellon workers, vaccinated with two doses in January and February 2021. We measured IgG antibodies against protein N (IgG-NP), IgM against protein S (IgM-S), and quantitative levles of IgG against protein S (IgG-Quant) one month after the last dose. We obtained information on demographic, risk factors, and vaccine side effects via a self-completed questionnaire. For the statistical analysis we used multiple regression models. RESULTS: Two hundred seventy-five workers participated (96.8%, 275/284). Positive IgG-Quant, IgM-S, and IgG-NP were 99.6%, 14.9% and 4.4%, respectively. Adjusted IgG-Quant levels increased significantly with obesity, nonsmoking status, positive IgM-S, and/or IgG-NP. The prevalence of IgM-S was higher in males, and associated with the same factors as those for IgG-Quant. Among those with a history of COVD-19 infection, 42.9% did not have IgG-NP. Overall 86.5% of participants had side effects, which were associated with positive IgG-NP, high IgG-Quant levels, younger age, and being female. CONCLUSIONS: All but one participant developed immunity. Those who had suffered from COVID-19 infection had higher antibody levels. A high proportion of participants had mild secondary effects, especially those with previous COVID-19 infection.

Introducción: Evaluar la inmunidad de los trabajadores de un hospital tras haber completado la vacunación Pfizer-BionTech, y su relación con factores individuales. También describir los efectos adversos de la vacuna. Método: Estudio transversal de una muestra de los trabajadores del Hospital General Universitario de Castellón vacunados con dos dosis en enero y febrero de 2021. Un mes después se detectaron: anticuerpos IgG frente a la proteína N (IgG-NP), de IgM frente a la proteína S (IgM-S) y detección cuantitativa de IgG frente a la proteína S (IgG-Quant). Se utilizó un cuestionario para recoger datos demográficos, factores de riesgo y efectos secundarios. En el análisis estadístico se utilizaron modelos de regresión múltiple. Resultados: La participación fue del 96,8% (275/284). Presentaron IgG-Quant el 99,6%, 14,9% IgM-S, y 4,4% IgG-NP. El nivel ajustado de IgG-Quant aumentó significativamente con la obesidad, en no fumadores y con positividad IgM-S y/o IgG-NP. La prevalencia de IgM-S era mayor en varones, y se asociaba con los mismos factores que la IgG-Quant. De los infectados por COVID-19, el 42,9% no presentaron IgG-NP. Un 86,5% sufrió algún efecto secundario que se asoció a tener IgG-NP, mayores niveles de IgG-Quant, y fue más frecuente en jóvenes y mujeres. Conclusiones: Todos los participantes desarrollaron inmunidad humoral excepto uno. Tuvieron mayores niveles de anticuerpos los que habían padecido la COVID-19. Un porcentaje alto desarrolló efectos secundarios leves, más frecuentes en los que habían padecido la enfermedad.

Low influenza vaccine effectiveness and the effect of previous vaccination in preventing admission with A(H1N1)pdm09 or B/Victoria-Lineage in patients 60 years old or older during the 2015/2016 influenza season.

BACKGROUND: The 2015/2016 influenza season was characterized in Europe by the circulation of A(H1N1)pdm09 clade 6B.1 and B/Victoria-lineage influenza viruses. The components of the vaccines used in the current and past two seasons in the Valencia region were similar but not well matched to the 2015/2016 dominant influenza-circulating strains. We estimate influenza vaccine effectiveness (IVE) and interference of previous vaccination in preventing admission with A(H1N1)pdm09 or B/Victoria-lineage in this particular season. METHODS: The Valencia Hospital Network for the Study of Influenza runs an active surveillance hospital-based study to collect clinical and virological data from consecutive admissions possibly related to influenza. Combined nasopharyngeal and pharyngeal swabs are analyzed by reverse transcription polymerase chain reaction, and the hemagglutinin is sequenced in a sample of positive influenza specimens. Vaccination is ascertained consulting a population vaccine information system. We estimate IVE using a test-negative approach. RESULTS: During the 2015-2016 season, we recruited 1049 eligible admissions of patients 60 years or older, and 187 tested positive for influenza. The adjusted IVE in preventing admission with A(H1N1)pdm09 was 20.2%; 95% confidence interval (CI) -21.3-47.5% and -33.2%; 95% CI, -140.1-26.1% in preventing admission with B/Victoria-lineage. The majority of A(H1N1)pdm09 sequenced viruses belonged to the emerging 6B.1 subclade, defined by S162N and I216T mutations in the hemagglutinin protein. When we restricted our analysis to those not vaccinated in the previous year, unadjusted IVE was 84.9% (95% CI 9.9-100.0) overall, 77.9% (-32.7-100.0%) in preventing A(H1N1)pdm09 and 48.8% (-219.5-100.0%) in preventing B/Yamagata-lineage admission. CONCLUSIONS: Our findings indicate that IVE was low in preventing A(H1N1)pdm09 and strongly correlated with vaccination in the previous season. No effect in preventing admission with B/Victoria-lineage was observed. For the 2015/2016 season, IVE was low due to a mismatch and lack of concordance between the circulating and vaccine viruses.

Respuesta vacunal frente a SARS-CoV-2 en trabajadores de un hospital / Vaccine response to SARS-CoV-2 in hospital workers

Introducción: Evaluar la inmunidad de los trabajadores de un hospital tras haber completado la vacunación Pfizer-BionTech, y su relación con factores individuales. También describir los efectos adversos de la vacuna. Método: Estudio transversal de una muestra de los trabajadores del Hospital General Universitario de Castellón vacunados con dos dosis en enero y febrero de 2021. Un mes después se detectaron: anticuerpos IgG frente a la proteína N (IgG-NP), de IgM frente a la proteína S (IgM-S) y detección cuantitativa de IgG frente a la proteína S (IgG-Quant). Se utilizó un cuestionario para recoger datos demográficos, factores de riesgo y efectos secundarios. En el análisis estadístico se utilizaron modelos de regresión múltiple. Resultados: La participación fue del 96,8% (275/284). Presentaron IgG-Quant el 99,6%, 14,9% IgM-S, y 4,4% IgG-NP. El nivel ajustado de IgG-Quant aumentó significativamente con la obesidad, en no fumadores y con positividad IgM-S y/o IgG-NP. La prevalencia de IgM-S era mayor en varones, y se asociaba con los mismos factores que la IgG-Quant. De los infectados por COVID-19, el 42,9% no presentaron IgG-NP. Un 86,5% sufrió algún efecto secundario que se asoció a tener IgG-NP, mayores niveles de IgG-Quant, y fue más frecuente en jóvenes y mujeres. Conclusiones: Todos los participantes desarrollaron inmunidad humoral excepto uno. Tuvieron mayores niveles de anticuerpos los que habían padecido la COVID-19. Un porcentaje alto desarrolló efectos secundarios leves, más frecuentes en los que habían padecido la enfermedad (AU)

Introduction: The aim of this study was to measure anti-SARS-CoV-2 immunity of hospital workers after a completed 2-dose Pfizer-BionTech vaccination, and to examine factors potentially associated with immunity status. Side effects of the vaccine were also studied. Method: This was a cross-sectional study of a representative sample of General University Hospital of Castellon workers, vaccinated with two doses in January and February 2021. We measured IgG antibodies against protein N (IgG-NP), IgM against protein S (IgM-S), and quantitative levles of IgG against protein S (IgG-Quant) one month after the last dose. We obtained information on demographic, risk factors, and vaccine side effects via a self-completed questionnaire. For the statistical analysis we used multiple regression models. Results: Two hundred seventy-five workers participated (96.8%, 275/284). Positive IgG-Quant, IgM-S, and IgG-NP were 99.6%, 14.9% and 4.4%, respectively. Adjusted IgG-Quant levels increased significantly with obesity, nonsmoking status, positive IgM-S, and/or IgG-NP. The prevalence of IgM-S was higher in males, and associated with the same factors as those for IgG-Quant. Among those with a history of COVD-19 infection, 42.9% did not have IgG-NP. Overall 86.5% of participants had side effects, which were associated with positive IgG-NP, high IgG-Quant levels, younger age, and being female. Conclusions: All but one participant developed immunity. Those who had suffered from COVID-19 infection had higher antibody levels. A high proportion of participants had mild secondary effects, especially those with previous COVID-19 infection (AU)

Concordancia entre la prueba de la tuberculina y el Interferon Gamma Release Assay-IGRA en pacientes con enfermedades inflamatorias mediadas por la inmunidad / Concordance between the test of the tuberculin and Interferon Gamma Release Assay-IGRA in patients with immune-mediated inflammatory diseases

INTRODUCCIÓN: Las terapias inmunosupresoras en el tratamiento de las enfermedades inflamatorias mediadas por la inmunidad (EIMI) predisponen a la tuberculosis, por lo que el cribado de infección tuberculosa latente (ITL) y su tratamiento reduce la probabilidad de progresión a tuberculosis activa. El objetivo del estudio fue analizar la concordancia entre la prueba de la tuberculina (PT) e "Interferon Gamma Release Assay-IGRA" en relación con el tipo de EIMI y tratamiento inmunosupresor (IS). MATERIAL Y MÉTODOS: Estudio transversal en pacientes con EIMI candidatos o en tratamiento IS remitidos para cribado de ITL, de Abril del 2017 hasta Mayo del 2018. Variables resultado fueron PT e IGRA. Variables explicativas: EIMI, IS, edad, sexo, vacunación BCG previa y factores de riesgo de tuberculosis. RESULTADOS: Se estudiaron 146 pacientes (33 [22,6%] vacunados con BCG, 1 [0,7%] con diagnóstico previo de tuberculosis y 22 [15,1%] originarios de país endémico). Índice de Kappa (k) fue de 0,338 entre PT e IGRA para la totalidad de la muestra. Menor concordancia en pacientes con enfermedad de Crohn (k=0,125), en los tratados con corticoides (k=0,222), vacunados con BCG (k=0,122) y en pacientes procedentes de países endémicos de tuberculosis (k=0,128). CONCLUSIONES: La concordancia entre la PT y el IGRA se ve afectada en pacientes con EIMI y en mayor medida en la enfermedad inflamatoria intestinal, con la corticoterapia, con la vacunación con BCG o en los procedentes de países endémicos

INTRODUCTION: The immunosuppressive therapies in the treatment of the immune-mediated inflammatory diseases (EIMI) predispose individuals to the tuberculosis, so the screening of latent tuberculosis infection (ITL) and the treatment reduces the likelihood of a progression to an active tuberculosis. The aim of the study was to analyze the concordance between the test of the tuberculin (PT) and "Interferon Gamma Release Assay-IGRA" in relation to the type of EIMI and the immunosuppressive treatment (IS). MATERIAL AND METHODS: Transversal study of patients with EIMI candidates or in treatment IS forwarded to the ITL screening, from April 2017 until May 2018. The outcome variables were PT and IGRA. The explicative variables were: EIMI, IS, age, gender, prior BCG vaccination and tuberculosis risk factors. RESULTS: A total of 146 patients were analyzed (33[22.6%] vaccinated with BCG, 1 [0.7%] with a pre-diagnosis of tuberculosis, and 22 [15.1%] from an endemic country). Kappa index (k) was 0,338 between PT and IGRA for the whole sample. A lower concordance was found in patients with the Crohn's disease (k=0.125), in the ones treated with corticosteroids (k=0.222), vaccinated with BCG (k=0.122) and in patients from tuberculosis endemic countries (k=0.128). CONCLUSION: The concordance between PT and IGRA is affected in patients with EIMI, and to a greater extent to patients with the inflammatory bowel disease, with the corticotherapy, with the BCG vaccination, or in the ones from endemic countries