Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age: A Phase 1/2 Randomized Trial.

BACKGROUND: Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants. METHODS: Healthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years. RESULTS: Two hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post-ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post-dose 2. CONCLUSIONS: ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response. Clinical Trials Registration. NCT03636906.

Consensus document of the Spanish Society of Paediatric Infectious Diseases and the Advisory Committee on Vaccines of the Spanish Association of Pediatrics for vaccination of immunosuppressed individuals.

The number of people with immunosuppression is increasing considerably due to their greater survival and the use of new immunosuppressive treatments for various chronic diseases. This is a heterogeneous group of patients in whom vaccination as a preventive measure is one of the basic pillars of their wellbeing, given their increased risk of contracting infections. This consensus, developed jointly by the Sociedad Española de Infectología Pediátrica (Spanish Society of Pediatric Infectious Diseases) and the Advisory Committee on Vaccines of the Asociación Española de Pediatría (Spanish Association of Paediatrics), provides guidelines for the development of a personalised vaccination schedule for patients in special situations, including general recommendations and specific recommendations for vaccination of bone marrow and solid organ transplant recipients, children with inborn errors of immunity, oncologic patients, patients with chronic or systemic diseases and immunosuppressed travellers.

Evolución y características de los ingresos por COVID-19 pediátricos en un hospital terciario

Introducción. La mayoría de infecciones por SARS-CoV2 en población pediátrica cursan asintomáticas o con síntomas leves, con porcentaje mínimo de casos graves descritos como síndrome inflamatorio multisistémico asociado al SARS-CoV2 (SIM-PEDs). El objetivo fue describir las características clínico-epidemiológicas de aquellos pacientes pediátricos ingresados con diagnóstico confirmado de SARS-CoV2, y las posibles diferencias de la enfermedad considerando dos períodos epidemiológicos. Material y métodos. Estudio retrospectivo observacional de pacientes pediátricos ingresados con diagnóstico de COVID-19, de un hospital terciario. Se recogieron de forma consecutiva, entre marzo de 2020 hasta febrero 2022, analizando datos demográficos, clínicos, pruebas complementarias, tratamiento administrado y evolución. Resultados. Se incluyeron 69 pacientes, clasificándose en 6 grupos según diagnóstico. Los pacientes con neumonía asociaban mayor hipoxemia, mayor edad y eran predominantemente varones (p<0.01), con respecto al grupo de infecciones respiratorias sin condensación. SIM-PEDs fueron pacientes más graves, con afectación analítica marcada y mayor ingreso en UCIP. Durante el 2º periodo se observa una tendencia a la disminución de la infección respiratoria (69% al 47%), menor estancia hospitalaria (de 4 a 3 días), y aumento de los ingresos por otra patología (7,7% al 30,6%). Conclusiones. Los cuadros clínicos de COVID-19 más frecuentes en niños son respiratorios leves-moderados con buena evolución. Hay una tendencia a menor duración de estancia hospitalaria y aumento de ingresos por otra patología en pacientes asintomáticos en el segundo periodo. SIM-PEDs es otra forma de expresión de infección por SARS-COV2 de mayor gravedad, pero habitualmente con buen pronóstico tras diagnóstico precoz y requiriendo frecuentemente ingreso en UCIP. (provisto por Infomedic International)

Introduction. Most SARS-CoV2 infections in pediatric population are asymptomatic or have mild symptoms, with a small percentage of severe cases described as SARS-CoV2-associated multisystem inflammatory syndrome (MIS-C). The objective was to describe the clinical-epidemiological characteristics of those pediatric patients admitted with a SARS-CoV2 confirmed diagnosis, and the possible differences in the disease considering two epidemiological periods. Methods. Observational retrospective study of pediatric patients admitted with a diagnosis of COVID-19, from a tertiary hospital. They were collected consecutively, between March 2020 and February 2022, analyzing demographic and clinical data, complementary tests, administered treatment and evolution. Results. 69 patients were included, classified into 6 groups according to diagnosis. Patients with pneumonia associated greater hypoxemia, older age and were predominantly male (p<0.01), with respect to the group of respiratory infections without condensation. MIS-C were more severe patients, with marked analytic involvement and greater admission to the PICU. During the 2nd period, there was a trend towards a decrease in respiratory infection (69% to 47%), a shorter hospital stays (4 to 3 days), and an increase in admissions for another pathology (7.7% to 30,6%). Discussion. The most frequent clinical manifestations of COVID-19 in children are mild-moderate respiratory symptoms with a good prognosis. There is a trend towards a shorter length of hospital stay and an increase in admissions for another pathology in asymptomatic patients in the second period. MIS-C is another form of expression of SARS-COV2 infection of greater severity, but usually with a good prognosis after early diagnosis and frequently requiring PICU admission. (provided by Infomedic International)

Retinal and peripapillary vessel density increase in recovered COVID-19 children by optical coherence tomography angiography.

PURPOSE: To evaluate retinal vascular changes in children who have recovered from coronavirus disease (COVID-19) using optical coherence tomography angiography (OCTA) and to compare the results with age-matched healthy children. METHODS: In this cross-sectional case-control study, children 6-18 years of age with laboratory-confirmed SARS-CoV-2 infection were compared with historic healthy controls. All participants underwent ophthalmological examination, including fundus photography and OCTA of the macular region and optic disk. COVID-19 children were examined 4-8 weeks after COVID-19 diagnoses. Demographic data, medical history, and COVID-19 symptoms were noted. OCTA parameters in the superficial capillary plexus (SCP) were analyzed according to ETDRS sectors and peripapillary quadrants. RESULTS: A total of 72 patients were included: 27 recovered COVID-19 children and 45 controls. Mean age for cases was 11.96 ± 3.8 years (18 females [66%]); for controls, 11.02 ± 2.0 years (29 females [64%]). Macular OCTA of the SCP showed a significant increase in retinal vessel density (VD) in recovered COVID-19 children compared with healthy controls in the inner ring (P = 0.001). Macular perfusion density (mPD) was also increased in the inner ring (P = 0.001). Peripapillary OCTA evidenced a significant higher flux index (FI) in all four quadrants (P < 0.001). CONCLUSIONS: Recovered COVID-19 children present increased retinal VD, mPD, and peripapillary FI shortly after recovery. Since the retinal vasculature is considered a unique window to assess microvascular changes, these findings may represent a potential in vivo biomarker of vascular abnormalities in COVID-19 children in other organs.

[Fungal infection in immunocompromised children]. / La infección fúngica en el paciente pediátrico inmunodeprimido.

In recent years, immunodeficiency condition has experienced a rise among children, who are at risk of invasive fungal infections (IFI) due to their health condition. Cancer, non-malignant hematological diseases, as primary immunodeficiencies, hematopoietic stem cell transplantation (HSCT), extreme prematurity, or critically ill condition in Pediatric Intensive Care Unit (PICU) are some immunosuppressive situations in children. The use of oncologic therapies, including immunotherapy and monoclonal antibodies, for the treatment of the aforementioned health conditions has led to an increase in morbidity and mortality rates of IFI in children. The underlying diseases and their management, comorbidities, the diagnostic tests used (both molecular and imaging), as well as the treatment used can be significantly different between adult patients and children admitted to PICU or with cancer. In pediatrics, the treatment of IFI is based primarily on pharmacokinetic studies performed in adults. In higher risk patients prophylaxis should be considered and, in the case of an IFI diagnosis, an antifungal treatment should be administered as early as possible, supported by the reversion of the immune dysfunction and surgery when appropriate.

Disseminated Tuberculosis Complicated With Pneumatoceles in 2 Infants.

Pneumatoceles are rare complications of pulmonary tuberculosis in children. We present 2 cases in infants of disseminated tuberculosis complicated by pneumatoceles with different evolution. This complication should be considered if worsening of respiratory symptoms occurs after initiating anti-tuberculous treatment. Treatment of pneumatoceles is usually conservative and surgical treatment should be used in patients with giant cysts which cause respiratory distress.

[Psychosocial assessment in transgender adolescents]. / Evaluación psicosocial en adolescentes transgénero.

OBJECTIVES: To evaluate the psychosocial status of the patients who attend a paediatric endocrinology clinic due to gender incongruity (GI), and to establish the impact on this after one-year of cross hormonal therapy (CHT). MATERIAL AND METHODS: An analytical and prospective study conducted on adolescents between 14 and 18 years old with GI, and who attended the Endocrinology clinic during 2018-2019. The sample included 23 transgender cases (16 male and 7 female cases) and 30 cisgender controls. Study variables were collected at T0 (pre-treatment) and T1 (after one year of CHT) and included sociodemographic data, Utrecht test, SDQ-Cas test, family APGAR test, STAI scale-anxiety Grade, and BDI-II depression assessment test. RESULTS: A significant improvement (P<.05) was found between T0 and T1 in the transgender group in terms of emotional symptoms, behaviour problems, hyperactivity symptoms, pro-social conduct, as well as in the degree of anxiety and depression measured by the SDQ-Cas test, the STAI and the BDI-II scale. There were significant differences in these scales between the transgender group and the controls at T0, however, the scores equalised at T1. The families in this sample of transgender patients provided a very favourable environment according to the scores obtained on the family APGAR scale. CONCLUSIONS: The rates of anxiety, emotional and behaviour distress, depressive symptomatology, as well as the feeling of gender dysphoria of these transgender patients were similar to those of non-transsexual population of the same age after one year of CHT initiated at ages between 14-18 years old.

Artritis séptica de rodilla por Kingella kingae: Presentación de dos casos clínicos

Kingella kingae es un colonizador habitual de la orofaringe en niños pequeños. Aunque en la mayoría de ocasiones la colonización es asintomática, puede dar lugar a infección invasiva. Este microorganismo ha sido crecientemente identificado como agente causal de infección osteoarticular en niños. Los datos limitados de artritis séptica por K. kingae y la dificultad para su identificación en los medios de cultivo habituales, pueden ocasionar retraso diagnóstico y en el inicio del tratamiento. Presentamos dos casos clínicos de lactantes con artritis séptica por K. kingae diagnosticada mediante PCR en líquido articular. El primero de ellos se trata de una mujer de 20 meses con sospecha inicial de sinovitis transitoria de cadera derecha, que acude a urgencias por cojera de 10 días de evolución. Ingresa tras 48 horas de fiebre y tumefacción de rodilla derecha, instaurándose tratamiento empírico con cloxacilina y cefotaxima tras diagnóstico de artritis séptica. Se obtiene PCR positiva para K. kingae en líquido articular. El segundo es un varón de 20 meses que acude a urgencias por dolor, tumefacción y limitación a la flexión de rodilla izquierda de 2-3 semanas, que en las últimas 24 horas se acompaña de fiebre de hasta 38.5ºC. Cuadro catarral previo. Ingresado una semana antes por el mismo motivo, con analítica sin alteraciones y análisis del líquido articular normal. De nuevo se decide ingreso repitiendo las pruebas complementarias e iniciando tratamiento empírico con cloxacilina y cefotaxima. Identificación de K. kingae mediante PCR en segunda muestra de líquido articular. Ambos casos presentaron buena evolución sin secuelas posteriores.

Kingella kingae is a common colonizer of the oropharynx in young children. Although most colonization is asymptomatic, it can lead to invasive infection. This microorganism is increasingly recognized as a cause of osteoarticular infections in children. The limited data of septic arthritis due to K. kingae and the difficulty to identify this organism in routine cultures, can delay the diagnosis and treatment. Two cases of infants with septic arthritis by K. kingae diagnosed by PCR are described. The first one is about a 20-month-old woman with initial suspicion of transient synovitis of the right hip, who came to the emergency department with limping in the last 10 days. She is admitted to hospital because of fever and inflammation on the right knee for 48 hours. We initiated empirical treatment with cefotaxime and cloxacillin after diagnosis of septic arthritis. Positive PCR for K. kingae was obtained in joint fluid. The second case is about a 20-month-old male who came to the emergency room due to pain, swelling and limitation to left knee flexion, 2-3 weeks of evolution, accompanied by fever for the last 24 hours (38.5ºC). He had the antecedent of catarrhal picture previously. He had been admitted to hospital the previous week because of the same symptoms, with blood and joint fluid exams without alterations. He is admitted again with empirical treatment with cloxacillin and cefotaxime after repeating the laboratory exams. K. kingae was identified by PCR in the second sample of joint fluid. Both cases presented had good evolution without subsequent sequels.

Pilomatricoma como diagnóstico diferencial de adenitis cervical granulomatosa

El niño con una masa cervical representa un desafío para el pediatra. Lo más frecuente en niños son los procesos benignos de origen infeccioso. Presentamos un niño con tumoración laterocervical posterior con diagnóstico de pilomatricoma, tumor benigno poco conocido en Pediatría . No presenta características específicas, por lo que su diagnóstico se base en el estudio de anatomía patológica. El único tratamiento posible es la exéresis completa. El pilomatricoma se debe incluir en el diagnóstico diferencial de adenitis cervical en niños para evitar intervenciones y tratamientos innecesarios.

Children with neck masses are an everyday challenge for pediatricians. Infectious diseases are the most common etiology in childhood. We report a child with a neck mass who was diagnosed with pilomatrixoma. It is a quite unknown benign skin tumor in pediatrics. It cannot be easily differentiated from other skin tumors, and biopsy is necessary to make the definitive diagnosis. Treatment of pilomatrixoma consists of total surgical excision. Pilomatrixoma should be considered in the differential diagnosis of cervical lymphadenitis in children to avoid unnecessary interventions and antibiotic treatment.

Sepsis neonatal tardía por Estreptococo del grupo B. Transmisión a través de lactancia materna

Objetivo: El estreptococo del grupo B (SGB) o Streptococcus agalactiae es una causa importante de infección bacteriana en el recién nacido, con dos formas clínicas de afectación precoz y tardía. De esta última , se conocen diferentes mecanismos de transmisión horizontal, nosocomial o adquirida en la comunidad. Existen pocos casos descritos en la literatura en los que la ingestión de la leche materna colonizada por SGB fuera causa de infección tardía en el recién nacido. En el presente artículo describimos un caso de sepsis-meningitis tardía por SGB transmitido por leche materna en una madre sin mastitis. Revisaremos además la patogénica de esta enfermedad y la controversia existente acerca del tratamiento materno o la retirada de la lactancia materna en estos casos.

Objective: Group B streptococcus (GBS) or Streptococcus agalactiae is a major cause of bacterial infection in the newborn, with two clinical forms: early and late-onset infection. Of the latter we know different transmission mechanisms: horizontal, nosocomial or community acquired. There are few cases reported in the literature in which the ingestion of breast milk colonized by GBS was the cause of late infection in the newborn. In this paper, we report a case of late-onset sepsis and meningitis due to GBS transmitted through breast milk in a mother without mastitis. We will also review the pathogenesis of this disease and the controversy about treatment or withdrawal of maternal breastfeeding in these cases.

PFAPA syndrome in siblings. Is there a genetic background?

UNLABELLED: "PFAPA syndrome" is an autoinflammatory entity composed of periodic fever, aphthous stomatitis, pharyngitis, and cervical adenitis. There have been many reports of children with the disease, but only occasionally have been described in siblings, and no specific genetic mutation has been determined yet. Corticosteroids are the mainstay in the treatment of the acute attacks. The role of surgery in long-term follow-up (tonsillectomy with or without adenoidectomy) is controversial. We report two brothers affected with the syndrome, in whom corticosteroids as the only treatment led to an improvement. A genetic work-up was performed, making very unlikely other possible syndromes of recurrent fever. CONCLUSION: PFAPA syndrome is the most common recurrent periodic fever disorder described in childhood. Its genetic background has not been elucidated yet. Our contribution with two siblings affected with PFAPA syndrome further support the genetic basis for the entity.

[Why might micafungin be the drug of choice in pediatric patients?]. / ¿Por qué micafungina puede ser de elección en el paciente pediátrico?

Micafungin is an echinocandin approved by the European Medicines Evaluation Agency for the treatment of invasive candidiasis in children, including premature infants born before 29 weeks of pregnancy, and as prophylaxis in children undergoing hematopoietic stem-cell transplantation or patients at risk of prolonged neutropenia. This drug has good activity in several Candida spp., including those resistant to fluconazole. Although micafungin is active against Aspergillus spp., it has been used mainly in combination therapy for invasive aspergillosis. There is ample information on the use of micafungin in children, including neonates, and this drug is the only echinocandin approved for use in infants aged less than 3 months. The efficacy, pharmacokinetics and safety of micafungin have been evaluated in phase II and III clinical trials in children, in which its efficacy and safety were demonstrated in comparison with liposomal amphotericin B and fluconazole. The pharmacokinetic profile of micafungin in children allows once daily intravenous administration, with greater clearance than in adults, and consequently pediatric doses are relatively higher. The most appropriate dose in children weighing less than 40 kg is 2 mg/kg/day in the treatment of invasive candidiasis and 1 mg/kg/day as prophylaxis in children undergoing hematopoietic stem-cell transplantation. Doses in neonates should be higher. In premature infants, the most appropriate doses to achieve levels in the brain parenchyma are 7 mg/kg/day and 10 mg/kg/day in those weighing more and less than 1,000 g, respectively. Micafungin has few drug-drug interactions and an acceptable safety profile. Withdrawal of this drug due to adverse effects is rare, although transaminase monitoring is recommended during treatment, as well as evaluation of the risk-benefit balance in patients with liver disease or concomitant administration of hepatotoxic drugs.