Adjuvants and alternative routes of administration towards the development of the ideal influenza vaccine.

Vaccination is universally considered as the principal measure for the control of influenza, which represents a significant burden worldwide, both from a health-care and a socio-economic viewpoint. Conventional non-adjuvanted trivalent influenza vaccines (TIVs) have been recognized as having some deficiencies, such as suboptimal immunogenicity particularly in the elderly, in patients with severe chronic diseases and immunocompromized, indeed, those groups of the population at higher risk of developing severe complications following influenza infection, when compared to healthy adults. Moreover, the protection offered by conventional vaccines may be reduced by periodic antigenic drifts, resulting in a mismatch between the circulating and vaccinal viral strains. Another gap regarding currently available vaccines is related to the egg-based manufacturing system for their production: not only the length of time involved with the latter but also the limited capacity of this platform technology represent a major limitation for the active prevention of influenza, which is particularly important in the case of a new pandemic strain. New technologies used in vaccine composition, administration and manufacture have led to major advances during the last few years, and clinical researchers have continued to work hard, investigating several different strategies to improve the performance of influenza vaccines: namely, the addition of different adjuvants (i.e., MF59- and AS03-vaccines, virosomal formulations), the use of alternative routes of administration or manufacture (i.e., intradermal, nasal and oral vaccines and cell culture- and reverse genetic-based vaccines) or of high doses of antigen, and the development of DNA-vaccines, or the use of conserved viral epitopes (i.e., the extracellular portion of the M2 protein, the nucleoprotein and some domains of the hemagglutinin), in the attempt to produce a "universal target" antigen vaccine. The knowledge acquired represents a fundamental challenge for the control of influenza. An overview of the most recent and interesting results, some of which gained from our own research experience, particularly concerning two successful approaches, of those outlined above, namely the use of: (i) the oil-in-water MF59-adjuvant, and (ii) the intradermal (ID) route for vaccine administration, through a novel microinjection system, will be reported and discussed, together with the possible implications and perspectives to optimize immunization policies against influenza in the near future

Influenza vaccination among Health Care Workers at a Regional University Adult Acute-Care Hospital in Genoa, Liguria, Italy: results from a project promoting awareness and active offer during the period 2005-2011

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Adherence to international and national recommendations for the prevention of surgical site infections in Italy: Results from an observational prospective study in elective surgery

Background: An observational prospective study of the perioperative procedures for prevention of surgical site infections (SSIs) was carried out in a tertiary referral teaching hospital in Liguria, Italy, to evaluate their adherence to international and national standards. Methods: A 1-month survey was performed in all surgical departments, monitored by turns by trained survey teams. Data regarding presurgical patient preparation and intraoperative infection control practices were collected. Results: A total of 717 elective interventions were actively monitored in 703 patients who underwent surgery. Hair-shaving was performed mainly using a razor (92%) by the nurses (72.8%) on the day before the operation (83.5%). All of the patients showered, either with a common detergent (87%) or with an antiseptic solution (13%). Antimicrobial prophylaxis was administered properly in 75.7% of the patients at induction of anaesthesia; however, according to current Italian guidelines, inappropriate prophylaxis was provided in 55.2% patients. Appropriate antisepsis of the incision area was done in 97.4% of the operations, and nearly 90% of the interventions lasted less than the respective 75th percentile. The doors of the operating theatres were mostly open during the duration of the operation in 36.3% of the cases. Conclusions: This review of infection control policies identified significant opportunities for improving the safety and the quality of routine surgical practic

Vaccinazione antinfluenzale degli operatori sanitari presso l\u2019IRCCS AOU San Martino-IST di Genova: progetto-pilota di counselling e offerta attiva direttamente presso reparti a elevato rischio

Introduzione: La vaccinazione antinfluenzale \ue8 uno strumentofondamentale per la prevenzione dell\u2019influenza in ambito sa-nitario e la sua somministrazione agli Operatori Sanitari (OS)\ue8 raccomandata in oltre 40 Paesi, inclusi gli Stati Uniti d\u2019Ame-rica e molti Paesi dell\u2019Unione Europea. Nonostante questeraccomandazioni, in Italia la compliance degli OS alla vacci-nazione antinfluenzale \ue8 ampiamente inadeguata. Metodi.Apartire dalla stagione 2005/06, \ue8 stato effettuato un progettorivolto all\u2019incremento dei tassi di copertura della vaccinazioneantinfluenzale stagionale tra gli OS che lavorano pressol\u2019IRCCS AOU San Martino-IST di Genova, Italia, ospedale ter-ziario universitario, centro di riferimento regionale per acuticon 1300 posti letto. Risultati.Il tasso medio di copertura vac-cinale registrato nel periodo 2006-2013 \ue8 risultato pari al21,6%, con variazioni comprese tra l\u201911% e il 34%. Durantel\u2019ultima stagione influenzale (2013/14), i tassi di copertura vac-cinale per tipo di occupazione sono risultati pari al 30% tra imedici, 11% tra gli infermieri e 9% nelle restanti categorie diOS. Discussione.Nonostante quasi un decennio di interventi,i tassi di copertura vaccinale registrati nel nostro ospedale ri-mangono costantemente insoddisfacenti e molto distanti dal-l\u2019obiettivo minimo del 75% definito dal Ministero della Salute.Ulteriori interventi sono necessari per prevenire il rischio infettivo legato all\u2019influenza per gli OS e per i pazienti e risultafondamentale identificare e implementare nuove strategievolte all\u2019aumento della compliance degli OS, particolarmentedegli infermieri, alla vaccinazione antinfluenzale.Background.Influenza vaccination is a fundamental tool forthe prevention of influenza in healthcare settings and its ad-ministration to healthcare workers (HCWs) is recommendedin more than 40 countries including United States of Americaand many countries of the European Union. Despite these rec-ommendations, in Italy the compliance of HCWs to influenzavaccination is largely inadequate. Methods.Since the 2005/06season, a comprehensive multifaceted intervention projectaimed at increasing the seasonal influenza vaccination cover-age rates among HCWs was performed at the IRCCS AOU SanMartino IST teaching hospital in Genoa, Italy, the regional ter-tiary adult acute-care reference center with a 1300 bed capac-ity. Results.The average influenza vaccination coverage rateduring the period 2006-2013 was 21,6%, ranging between 11%and 34%. During the last influenza season (2013/14), vaccina-tion coverage rates by occupation type resulted 30% amongphysicians, 11% among nurses and 9% among other clinicalpersonnel. Discussion.Despite almost a decade of efforts, thevaccination coverage rates registered at our hospital steadilyremain unsatisfactory and very distant by the minimum ob-jective of 75% defined by the Italian Ministry of Health. Fur-ther efforts are necessary to prevent the risk of influenzaamong HCWs and patients and novel strategies need to beidentified and implemented in order to increase the compli-ance of HCWs, particularly nurses, with the seasonal influenzavaccinatio

Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly: An observational study in Liguria Region, Italy

Background: In September 2011 the European Medical Agency authorized the use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged \ue2\u89\ua550 years. The same occurred in the US in December 2011 when the Food and Drug Administration approved the use of PCV13 in the same target age-group with indication for the prevention of invasive pneumococcal diseases and community acquired pneumonia sustained by the serotypes contained in the vaccine. The Liguria Region, in Italy, implemented in 2013 an active and free of charge immunization strategy with PCV13 among adults affected by specific risk conditions and the elderly aged \ue2\u89\ua570 years. Methods: An observational study was performed in order to assess the safety and tolerability of PCV13 among elderly dwelling in the metropolitan area of Genoa, the capital city of Liguria Region. Eligible subjects, who received PCV13 following the public health immunization campaign at the Local Health Unit 3 of Genoa, provided a written informed consent to take part in the study. Eight-hundred-seventy-one subjects were enrolled between October 2013 and May 2014: all were monitored by qualified healthcare personnel for at least 30 min after vaccination at the outpatient clinics, in order to assess any possible sudden reaction. The occurrence of a series of local and systemic solicited reactions and of any unsolicited Adverse Events (AEs) was monitored using a self-administered clinical diary and by regular phone contacts up to 14 and 21 d following immunization, respectively. Moreover, a 6-months follow-up following vaccination was planned in order to monitor Severe Adverse Events (SAEs). Results: No sudden reaction occurred in vaccinees at the outpatient clinics. Pain (27.4%) was the most frequent reaction reported by subjects at the injection site, while new muscle pain (13.6%), fatigue (10.7%), and headache (9.9%) resulted the most common systemic reactions. Rates of the main reactions reported in this on-field study resulted generally lower than those registered in clinical trials performed in the elderly. The incidence of fever (2.2%) following vaccination was low at values superimposable to that reported in previous studies. Conclusion: This observational study showed a good safety and tolerability of PCV13 among the elderly in routine clinical practice further confirming the evidence coming from clinical trials in the same age-group

Acceptance and safety of the intradermal influenza vaccine among the elderly in Italy: An on-field national study

Introduction: An observational multicenter study was carried out in Italy, to evaluate the acceptability and safety of the new intradermal (ID) influenza vaccine (IntanzaR, Sanofi Pasteur SA, Lyon, France) among subjects aged 65 60 years, compared with that of other intramuscular (IM) influenza vaccines. Compliance with the use of the ID vaccine by healthcare professionals was also assessed. Methods: A previously validated and self-administered questionnaire, Vaccinees' Perception of Injection (VAPI\ua9), consisting of 21 questions, mainly focused on four dimensions (bother, arm movements, sleep, and acceptability), was administered to > 1,600 individuals with spontaneous access to outpatient clinics, located in Northern, Central, and Southern Italy, to evaluate the acceptance of the vaccines. Occurrence of solicited and unsolicited side effects and of serious adverse events was assessed in a subset of subjects (n = 500), using a clinical diary filled in by vaccinees following immunization. Compliance with the new ID vaccine by healthcare professionals was investigated using an ad-hoc questionnaire. Results: A very favorable opinion concerning the acceptability of both the vaccines under survey, with the most positive answers ranging between 75.5% and 94.9%, was registered within the study population. Also the compliance by healthcare professionals (n = 130) with the novel ID vaccine was favorable. No serious adverse event occurred during the 6-month follow-up period. The frequency of solicited systemic reactions was comparable between the two study groups, while solicited local reactions were significantly higher in the ID-vaccine group than in the IM-vaccine group, even if at values lower than those reported in phase 3 clinical trials (ranges = 18.5-32.6% vs. 29.5-70.9%). These local events were mild and transient, thus without any clinical relevance. Conclusion: The novel ID influenza vaccine can be widely recommended in clinical practice, representing a useful tool to improve immunization coverage rates, and thus the control of influenza. \ua9 Springer Healthcare 2012