SARS-CoV-2 infection risk is higher in vaccinated patients with inflammatory autoimmune diseases or liver transplantation treated with mycophenolate due to an impaired antiviral immune response: results of the extended follow up of the RIVALSA prospective cohort

BackgroundA relevant proportion of immunocompromised patients did not reach a detectable seroconversion after a full primary vaccination cycle against SARS-CoV-2. The effect of different immunosuppressants and the potential risks for SARS-CoV-2 infection in these subjects is largely unknown.MethodsPatients from the Rivalsa prospective, observational cohort study with planned anti SARS-CoV-2 third dose mRNA vaccination between October and December 2021 were asked to participate to this follow-up study. Patients were asked about eventual confirmed positivity to SARS-CoV-2 infection within 6 months from the third dose and to undergo a blood draw to evaluate seroconversion status after the additional vaccine shot.Results19 out of 114 patients taking part in the survey developed a confirmed SARS-CoV-2 infection; we identified mycophenolate treatment as an independent predictor of an increased risk of infection even after the third vaccine dose (OR: 5.20, 95% CI: 1.70-20.00, p=0.0053). This result is in agreement with the in vitro evidence that MMF impairs both B and T lymphocytes driven immune responses (reduction both in memory B cells producing anti-spike antibodies and in proliferating CD4+ and CD8+ T cells).ConclusionsImmunocompromised patients need an additional vaccine administration to reach a detectable seroconversion, thus fostering a more personalized approach to their clinical management. Moreover, patients undergoing mycophenolate treatment show a specific increased infection risk, with respect to other immunosuppressants thus supporting a closer monitoring of their health status

SARS-CoV-2 infection risk is higher in vaccinated patients with inflammatory autoimmune diseases or liver transplantation treated with mycophenolate due to an impaired antiviral immune response: results of the extended follow up of the RIVALSA prospective cohort

Background: A relevant proportion of immunocompromised patients did not reach a detectable seroconversion after a full primary vaccination cycle against SARS-CoV-2. The effect of different immunosuppressants and the potential risks for SARS-CoV-2 infection in these subjects is largely unknown.Methods: Patients from the Rivalsa prospective, observational cohort study with planned anti SARS-CoV-2 third dose mRNA vaccination between October and December 2021 were asked to participate to this follow-up study. Patients were asked about eventual confirmed positivity to SARS-CoV-2 infection within 6 months from the third dose and to undergo a blood draw to evaluate seroconversion status after the additional vaccine shot.Results: 19 out of 114 patients taking part in the survey developed a confirmed SARS- CoV-2 infection; we identified mycophenolate treatment as an independent predictor of an increased risk of infection even after the third vaccine dose (OR: 5.20, 95% CI: 1.70-20.00, p=0.0053). This result is in agreement with the in vitro evidence that MMF impairs both B and T lymphocytes driven immune responses (reduction both in memory B cells producing anti-spike antibodies and in proliferating CD4+ and CD8+ T cells).Conclusions: Immunocompromised patients need an additional vaccine administration to reach a detectable seroconversion, thus fostering a more personalized approach to their clinical management. Moreover, patients undergoing mycophenolate treatment show a specific increased infection risk, with respect to other immunosuppressants thus supporting a closer monitoring of their health status

Efficacia della medicazione sterile trasparente rispetto a quella standard per il fissaggio del catetere venoso periferico (CVP) sull’incidenza delle flebiti.Trial randomizzato e controllato

Le medicazioni del CVP possono contribuire all’incidenza di flebiti, infiltrazioni e sfilamenti accidentali, ma i risultati sono contrastanti e, in alcuni casi, con campioni troppo sottodimensionati. Obiettivo. Verificare l’incidenza delle flebiti da CVP con una medicazione sterile trasparente in film in poliuretano a copertura del punto di inserzione (medicazione [M] sterile) o con un cerotto non sterile (M standard). Disegno. Trial randomizzato e controllato. Partecipanti. 1061 CVP (703 pazienti) sia adulti che pediatrici in un ospedale di ricerca monospecialistico ortopedico del nord Italia. 540 CVP allocati a ricevere la M sterile e 521 la M standard. Risultati. 96 CVP sono stati rimossi per flebite, 48 (9.6%) nel gruppo sperimentale e 48 (10.1%) nel gruppo di confronto, RR 0.96 (I.C. 0.697 - 1.335). I CVP fissati con M sterile si sono sfilati più frequentemente (9.6% vs 6.3%); la percentuale di cateteri rimossi a fine trattamento in assenza di complicanze è stata maggiore nei CVP fissati con M standard (48.9% vs 54.9% p=0.0503). In 85 CVP la M è stata sostituita perché staccata (50, 9.2% - M sterile e 35, 6.7% - M standard). La M sterile trasparente utilizzata costa 32 centesimi al pezzo mentre quella standard 9 centesimi. Conclusioni. Utilizzare cerotti non sterili non influisce sull’incidenza di flebiti e garantisce un buon fissaggio del CVP alla cute rispetto alla medicazione sterile trasparente in film in poliuretan

Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project

Vaccination against communicable diseases is crucial for disease prevention, but this practice poses challenges to healthcare professionals in patients with haemophilia. Poor knowledge of the vaccination requirements for these patients and safety concerns often result in vaccination delay or avoidance. In order to address this issue, a panel of 11 Italian haemophilia and immunization experts conducted a Delphi consensus process to identify the main concerns regarding the safe use of vaccines in patients with haemophilia. The consensus was based on a literature search of the available evidence, which was used by the experts to design 27 consensus statements. A group of clinicians then rated these statements using the 5-point Likert-type scale (1 = strongly disagree; 5 = strongly agree). The main issues identified by the expert panel included vaccination schedule for haemophilic patients; protocol and optimal route of vaccine administration; vaccination of haemophilic patients with antibodies inhibiting coagulation factor VIII (inhibitors); and vaccination and risk of inhibitor development. This manuscript discusses these controversial areas in detail supported by the available literature evidence and provides evidence- and consensus-based recommendations. Overall, participants agreed on most statements, except those addressing the potential role of vaccination in inhibitor formation. Participants agreed that patients with haemophilia should receive vaccinations according to the institutional schedule for individuals without bleeding disorders; however, vaccination of patients with haemophilia requires comprehensive planning, taking into account disease severity, type and route of vaccination, and bleeding risk. Data also suggest vaccination timing does not need to take into consideration when the patient received factor VIII replacement