RESUMEN
BACKGROUND: We evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds. METHODS: This phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed. RESULTS: Overall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06-1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups. CONCLUSIONS: Adjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine. CLINICAL TRIALS REGISTRATION: NCT05568797.
RESUMEN
La actual pandemia por coronavirus SARS-CoV-2 está planteando una serie de desafíos al modo en que ejercemos la actividad médica y quirúrgica. En concreto, dentro de la neurocirugía se ha visto que los abordajes endoscópicos endonasales suponen un elevado riesgo de contagio para el personal sanitario que interviene en la misma, por lo que, inicialmente, la recomendación fue evitar dichas cirugías. Dado que la pandemia se ha extendido en el tiempo y desconocemos cuándo se podrá controlar, se deben proponer nuevas soluciones para continuar con la realización de dichos abordajes de manera segura. Ante la falta de protocolos establecidos, planteamos el siguiente, en el que se establecen, de modo conciso, las medidas a tomar tanto en cirugía urgente como programada, además de la descripción de un nuevo dispositivo de protección-aspirado (Maskpirator) AU)
Current SARS-CoV-2 coronavirus pandemic is challenging medical and surgical activities. Specifically, within neurosurgery, endoscopic endonasal approaches pose a high risk of contagion for healthcare personnel involved in it. Initially, the recommendation was to avoid such surgeries. However, the pandemic has dragged on and new solutions must be proposed to continue carrying out these approaches safely. Given the lack of established protocols, we propose the following one, which concisely establishes the measures to be taken in both urgent and scheduled surgery. In addition, a new protecti (AU)n-aspiration device (Maskpirator) is described.
Asunto(s)
Humanos , Infecciones por Coronavirus , Neumonía Viral , Pandemias , Medidas de Seguridad , Cirugía Endoscópica Transanal/normasRESUMEN
Current SARS-CoV-2 coronavirus pandemic is challenging medical and surgical activities. Specifically, within neurosurgery, endoscopic endonasal approaches pose a high risk of contagion for healthcare personnel involved in it. Initially, the recommendation was to avoid such surgeries. However, the pandemic has dragged on and new solutions must be proposed to continue carrying out these approaches safely. Given the lack of established protocols, we propose the following one, which concisely establishes the measures to be taken in both urgent and scheduled surgery. In addition, a new protection-aspiration device (Maskpirator) is described.
Asunto(s)
COVID-19 , Cirugía Endoscópica por Orificios Naturales/métodos , Procedimientos Neuroquirúrgicos/métodos , SARS-CoV-2 , COVID-19/complicaciones , COVID-19/transmisión , Humanos , Cirugía Endoscópica por Orificios Naturales/efectos adversos , Cirugía Endoscópica por Orificios Naturales/normas , Procedimientos Neuroquirúrgicos/efectos adversos , Procedimientos Neuroquirúrgicos/normas , PandemiasRESUMEN
Current SARS-CoV-2 coronavirus pandemic is challenging medical and surgical activities. Specifically, within neurosurgery, endoscopic endonasal approaches pose a high risk of contagion for healthcare personnel involved in it. Initially, the recommendation was to avoid such surgeries. However, the pandemic has dragged on and new solutions must be proposed to continue carrying out these approaches safely. Given the lack of established protocols, we propose the following one, which concisely establishes the measures to be taken in both urgent and scheduled surgery. In addition, a new protection-aspiration device (Maskpirator) is described.