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Vulnerability during the coronavirus disease 2019 (COVID-19) pandemic is an emotional state that affects all of us globally. The Italian experience shows that our general practitioners (GPs) seem to have a higher rate of death due to COVID-19 infection than other physicians. This article discusses clinical ethics questions related to the vulnerability of GPs and the community during the pandemic in Italy: the total lack of, or the inadequate protection of personal protective equipment, the increased use of virtual medicine, and the value of a solid synergy between hospitals and territorial systems. We provide a few examples of experiences in other affected countries and populations (Indigenous communities in Brazil, Australia and Germany). In conclusion, we offer some reflections on the crucial role of communication in dealing with vulnerability issues during this COVID-19 pandemic period.

Yeast cell wall (YCW) products are used worldwide as alternatives to antibiotics growth promoters for health and performances improvement in livestock. The success of yeast and YCW products as feed additives in farm animals' nutrition relies on their capacity to bind enteropathogenic bacteria and on their immunomodulatory activity. In vivo studies report their anti-infectious activity on Gram-positive pathogens like clostridia. However, the in vitro antimicrobial activity of YCW products seems to be limited to some Gram-negative enteropathogens, and literature lacks in vitro evidences for antimicrobial effect of YCW products against Clostridium perfringens. This study aims to measure the antimicrobial activity of YCW products on C. perfringens. Five different YCW products were assayed for their capacity to inhibit the growth of C. perfringens, by analyzing the growth kinetics of the pathogen. All YCW products inhibited the growth of the pathogen, by reducing the growth rate and the maximum growth value and extending the lag phase duration. The effect on the growth parameters was product and dosage dependent. The most effective YCW (namely YCW2), at the minimum effective concentration of 1.25 mg/mL, increased the lag phase duration by 3.6 h, reduced the maximum growth rate by >50%, and reduced the final cell count by 10(2) colony-forming unit per milliliter in 24 h, with respect to the control. YCW products did not show a strain-dependent impact on C. perfringens growth when tested on different strains of the bacterium.

Mycotoxins are secondary metabolites produced by a wide array of diverse fungal species, mostly belonging to the three genera Aspergillus, Penicillium and Fusarium. All species of livestock are affected by mycotoxins, being the monogastrics (swine, horses) the most sensitive, followed by poultry and ruminants. Controlling mould growth and mycotoxin production is very important to feed manufacturer and livestock producer. A variety of decontamination/detoxification methods show potential for commercial application. However, large-scale, practical, and costs-effective methods for a complete mycotoxin decontamination are currently not available. No single decontamination method that is equally effective against the variety of naturally occurring mycotoxins has been developed. The use of feed additives that reduce the exposure of the animals to these mycotoxins are regarded as a way to improve animal welfare. These additives are defined as substances (e.g. clay mineral, enzyme, micro-organism, yeast cell wall) that are mixed into feed and then adsorb or denature (biologically detoxify) mycotoxins in the digestive tract of animals. This chapter will present an overview on advances and criticisms regarding the use of mycotoxin-detoxifying agents, focusing on adsorbent materials for mycotoxin removal from feedstocks.

Background Community participatory interventions mobilizing women of childbearing age are an effective strategy to promote maternal and child health. In 2017, we implemented this strategy in Gulu Northern Uganda. This study explored the perceived impact of this approach on women's capability. Methods We conducted a qualitative study based on three data collection methods: 14 in-depth individual interviews with participating women of childbearing age, five focus group discussions with female facilitators, and document analysis. We used the Sen capability approach as a conceptual framework and undertook a thematic analysis. Results Women adopted safe and healthy behaviors for themselves and their children. They were also able to respond to some of their family's financial needs. They reported a reduction in domestic violence and in mistreatment towards their children. The facilitators perceived improved communication skills, networking, self-confidence, and an increase in their social status. Nevertheless, the women still faced unfreedoms that deprived them of living the life they wanted to lead. These unfreedoms are related to their lack of access to economic opportunities and socio-cultural norms underlying gender inequalities. Conclusion To expand women's freedoms, we need more collective political actions to tackle gender inequalities and need to question the values underlying women's social status.

Background South Sudan has one of the highest maternal mortality ratios in the world, at 789 deaths per 100,000 live births. The majority of these deaths are due to complications during labor and delivery. Institutional delivery under the care of skilled attendants is a proven, effective intervention to avert some deaths. The aim was to determine the prevalence and explore the factors that affect utilization of health facilities for routine delivery and postnatal care in Torit County, South Sudan. Methods A convergent parallel mixed method design combined a community survey among women who had delivered in the previous 12 months selected through a multistage sampling technique (n = 418) with an exploratory descriptive qualitative study. Interviews (n = 19) were conducted with policymakers, staff from non-governmental organizations and health workers. Focus group discussions (n = 12) were conducted among men and women within the communities. Bivariate and multivariate logistic regression were conducted to determine independent factors associated with institutional delivery. Thematic analysis was undertaken for the qualitative data. Results Of 418 participants who had delivered in the previous 12 months, 27.7% had institutional deliveries and 22.5% attended postnatal care at least once within 42 days following delivery. Four or more antenatal care visits increased institutional delivery 5 times (p p = 0.021). Women were more likely to plan and prepare for home delivery than for institutional delivery and sought institutional delivery when complications arose. Perceived poor quality of care due to absence of health staff and lack of supplies was reported as a major barrier to institutional delivery. Women emphasized fear of discrimination based on social and economic status. Unofficial payments such as soap and sweets were reported as routine expectations and another major barrier to institutional delivery. Conclusion Interventions to stop unofficial payments and discrimination based on socio-economic status and to increase access to ANC, delivery services and PNC are needed.

The world was never so close to reach the polio eradication: only 37 cases notified in 2016 in only three countries, but the game is not yet at the end. The risk of polio outbreaks in the EU is smaller than it has ever been in the past, but it is not so small that we can ignore it. The EU MS must remain alert and plan and prepare for managing polio events or outbreaks because of the possible dire consequences. The IPV only vaccination schedule universally applied in EU has achieved satisfactory coverage, but constantly leaving small accumulating pockets of susceptible individuals. Moreover the IPV only schedule is not an absolute barrier against poliovirus silent transmission as demonstrated in the recent Israel outbreak. The availability of annually revised S.O.P. from WHO GPEI on the identification and response of a polio event, without local poliovirus transmission or a polio outbreak with sustained transmission, helps and challenge EU countries to update their polio national preparedness plans. The EU/EEA area, in fact, is a peculiar area regarding the polio risk both for its vaccination policy, the large polio vaccines manufactures and the constant immigration from areas at polio high risk, but also EU include cultural and financial potentials crucial to sustain the polio end game strategy and reach the benefit of a world without polio risk. Poliovirus eradication will continue to be challenged as long as there is the worldwide presence of polioviruses in laboratories and vaccine production plants. Most of the world's OPV vaccines are produced in the EU and many laboratories and research centers store and handle polio viruses. EU Member States are engaged actively in implementing the poliovirus biocontainment plans that are part of the polio eradication strategy and to certify the destruction of poliovirus strains and potentially contaminated biological materials.

Mycotoxins are known worldwide as fungus-produced toxins that adulterate a wide heterogeneity of raw feed ingredients and final products. Consumption of mycotoxins-contaminated feed causes a plethora of harmful responses from acute toxicity to many persistent health disorders with lethal outcomes; such as mycotoxicosis when ingested by animals. Therefore, the main task for feed producers is to minimize the concentration of mycotoxin by applying different strategies aimed at minimizing the risk of mycotoxin effects on animals and human health. Once mycotoxins enter the production chain it is hard to eliminate or inactivate them. This paper examines the most recent findings on different processes and strategies for the reduction of toxicity of mycotoxins in animals. The review gives detailed information about the decontamination approaches to mitigate mycotoxin contamination of feedstuffs and compound feed, which could be implemented in practice.

Herpes zoster (HZ) is an acute viral illness characterized by a vesicular rash with unilateral distribution, which can also result in severe complications such as post-herpetic neuralgia (PHN), ophthalmic zoster, stroke or other neurological complications. The estimate incidence in Europe ranges between 2.0 and 4.6 cases per 1,000 person-years, with a sharp increase in >50 year-old subjects. Currently, treatment options for HZ are only partially effective in limiting the acute phase, while the management of complications is complex and often unsatisfactory. The total burden of the disease and the high costs related to its diagnostic and therapeutic management led researchers to develop a new preventive approach through a live attenuated virus vaccine. The currently available vaccine, with a high antigen content, is safe, well tolerated and reduces the incidence of HZ, PHN and the burden of illness. Several countries have introduced this vaccination, albeit with different recommendations and methods of financing. Taking into account the barriers to this immunization registered in some areas (difficulty of vaccine distribution, lack of physician recommendations, the cost of vaccine for patients, etc.), this group of Italian experts advocate that a common strategy able to guarantee a good compliance with this vaccination should be implemented. The same group addresses some practical questions concerning the use of zoster vaccine.

Epidemics and pandemics are natural events recurring over the time: their impact can be appropriately minimised but most countries only rely on emergency response. The European Decision 1082/2013 on serious cross-border threats to health is innovative in recognising risk communication as an essential tool in coping with public health emergencies of international concern (PHEIC). The Decision serves as proper context for the EU-funded ASSET (Action plan in Science in Society in Epidemics and Total pandemics) research project that aims to create the blueprint for a better response to PHEIC, through improved forms of dialogue and better cooperation at different levels on Science-in-Society (SiS) issues (governance, engagement, ethics, gender, science education, open access). A Mobilization and Mutual Learning (MML) approach was developed through the ASSET Strategic and Action Plans toward different targets and relevant stakeholders. An integrated participatory approach needs to be recognized into the national plans for preparedness and response.

Enteroviruses (EVs) cause severe outbreaks of respiratory and neurological disease as illustrated by EV-D68 and EV-A71 outbreaks, respectively. We have mapped European laboratory capacity for identification and characterisation of non-polio EVs to improve preparedness to respond to (re)-emerging EVs linked to severe disease. An online questionnaire on non-polio EV surveillance and laboratory detection was submitted to all 30 European Union (EU)/European Economic Area (EEA) countries. Twenty-nine countries responded; 26 conducted laboratory-based non-polio EV surveillance, and 24 included neurological infections in their surveillance. Eleven countries have established specific surveillance for EV-D68 via sentinel influenza surveillance (n = 7), typing EV-positive respiratory samples (n = 10) and/or acute flaccid paralysis surveillance (n = 5). Of 26 countries performing non-polio EV characterisation/typing, 10 further characterised culture-positive EV isolates, whereas the remainder typed PCR-positive but culture-negative samples. Although 19 countries have introduced sequence-based EV typing, seven still rely entirely on virus isolation. Based on 2015 data, six countries typed over 300 specimens mostly by sequencing, whereas 11 countries characterised under 50 EV-positive samples. EV surveillance activity varied between EU/EEA countries, and did not always specifically target patients with neurological and/or respiratory infections. Introduction of sequence-based typing methods is needed throughout the EU/EEA to enhance laboratory capacity for the detection of EVs.

ObjectiveTo examine their implementation, we analyzed World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) guidelines from 2005 to 2008 for risk communication during an emerging infectious disease outbreak, WHO and CDC reports on implementing the guidelines worldwide after the 2009 H1N1 pandemic; and a case study of a member state.MethodsA qualitative study compared WHO and CDC guidelines from 2005 to 2008 with WHO and CDC reports from 2009 to 2011, documenting their implementation during the H1N1 outbreak and assessed how these guidelines were implemented, based on the reports and Israeli stakeholders (n=70).ResultsEight risk communication subthemes were identified: trust, empowerment, uncertainty, communicating the vaccine, inclusion, identification of subpopulations and at-risk groups, segmentation, and 2-way communication. The reports and case study disclosed a gap between international guidelines and their local-level implementation. The guidelines were mostly top-down communications, with little consideration for individual member-state implementation. The WHO and CDC recommendations were not always based on formative evaluation studies, which undermined their validity.ConclusionsIn formulating effective communication strategies, the first step is to define the goal of a vaccination program. We recommend implementing conceptual elements from the most current theoretical literature when planning communication strategies and increasing organizational involvement in implementing guidelines in future health crises. (Disaster Med Public Health Preparedness. 2014;0:1–12)

Although vaccination is one of the most cost-effective health care interventions, under-vaccination and variation in coverage rates lower than policy targets is rising in developed countries, partly due to concerns about vaccination value and benefits. By merging various antigens into a single product, combination vaccines represent a valuable tool to mitigate the burden associated with the numerous injections needed to protect against vaccine preventable infectious diseases and increase coverage rate, possibly through various behavioral mechanisms which have yet to be fully explored. Beyond their cost-effectiveness in protecting against more diseases with fewer injections, combination vaccines also have several other benefits, for children, their parents/carers, as well as for the health system and the population as a whole. The objectives of this review are to identify and illustrate the value of combination vaccines for childhood immunization. Evidence was classified into 2 groups: benefits for society and benefits for public health and healthcare systems. This article also highlights the value of innovation and challenges of combination vaccine development as well as the need for an increased number of suppliers to mitigate the impact of any potential vaccine shortage. Increasing public confidence in vaccines and combination vaccines is also critical to fully exploit their benefits.

Population aging is the demographic phenomenon characterizing all countries in the world, and it is challenging the national infrastructures, in particular health systems. However, aging itself is not associated with increased medical spending, but disability and comorbidity that affect older individuals are the actual drivers for health expenditures. Therefore, if people age in better health, medical spending may be significantly reduced. Preventative interventions proved to be effective in reducing/preventing disease and disability and often found to be cost effective, include diet and exercise interventions, medications, routine disease screenings, and immunizations. Vaccination can protect older citizens against life-threatening diseases, such as influenza, pneumococcal infections, tetanus, and against diseases which adversely impact their quality of life, such as herpes zoster (HZ). Including HZ vaccination in its citizens' lifetime immunization calendar can reinforce Europe's commitment toward active, healthy aging. This paper outlines the consensus statement of a group of Italian experts on HZ.

Herpes Zoster (HZ) is a viral disease with painful neuro-dermatologic manifestations. Incidence increases with age. In Italy, the estimated incidence is 6.3 cases/1000 person/year; hospital admissions are less than 2%, 69% in patients aged over 65 years. The most frequent complication of HZ is Post-Herpetic Neuralgia (PHN) characterized by metameric pain, allodynia, and hyperalgesia. In Italy 20.6% and 9.2% of HZ patients experience PHN after 3 and 6 months, respectively. Available antiviral and analgesic treatments are relatively unsatisfactory in reducing pain and length of the disease. Prevention has recently become possible with the live attenuated vaccine Oka/Merck. Clinical studies show a reduction of 51% in the incidence of the disease, 61% of its burden and 67% of PHN in vaccinees. Protection seems to be long lasting and vaccine safety matches registration requirements. Available evidence suggests that the costs for QALY (less than € 20 000) and avoided cases is favorable. Due to the heavy burden of disease, it is time to offer this vaccination to elderly population.

Objective: During the last decade, a worldwide growing interest in evaluating performance of health services through ‘outcome studies’ took place. This study started in early 2002 and represents the first National Health System (NHS) experience to evaluate adjusted performance indicators at national level. The aim of this study was to compare 30 days mortality after coronary artery bypass graft (CABG) between cardiac surgery centres, adjusting by confounding risk factors. Methods: All patients, aged 15—99 years, undergoing a CABG intervention after 1st January 2002 in 82 participating centres were eligible for this observational longitudinal study. For each patient, data on severity and risk factors were collected (type of procedure, haemodynamic condition, co-morbidities, recent myocardial infarction and unstable angina, ventricular function, emergency condition, vital status at 30 days). Using a multiple logistic regression analysis the best predictive model was developed for risk-adjustment; a cross-validation procedure was applied; specific risk adjusted mortality rates (RAMR) were estimated. The overall study population was used as reference standard. Results: 34,310 isolated CABG were performed in 64 of the 82 participating centres. Thirty days mortality resulted 2.61%, ranging from 0.33 to 7.63%; eight centres presented a RAMR significantly lower and seven significantly higher than the reference. Conclusions: The study provides valid measures of the heterogeneity between outcomes of the Italian cardiac surgery centres, to support decision-makingbyNHS management and individualpatients. Althoughnotstatisticallysignificant, RAMRdroppedfromyear 2002 to 2004 (2.8—2.4%) suggesting that this comparative outcome assessment can contribute to the improvement of performances in cardiac surgery. # 2005 Elsevier B.V. All rights reserved.

From August 2000 through January 2001, a large epidemic of Ebola hemorrhagic fever occurred in Uganda, with 425 cases and 224 deaths. Starting from three laboratoryconfirmed cases, we traced the chains of transmission for three generations, until we reached the primary casepatients (i.e., persons with an unidentified source of infection). We then prospectively identified the other contacts in whom the disease had developed. To identify the risk factors associated with transmission, we interviewed both healthy and ill contacts (or their proxies) who had been reported by the case-patients (or their proxies) and who met the criteria set for contact tracing during surveillance. The patterns of exposure of 24 case-patients and 65 healthy contacts were defined, and crude and adjusted prevalence proportion ratios (PPR) were estimated for different types of exposure. Contact with the patient’s body fluids (PPR = 4.61%, 95% confidence interval 1.73 to 12.29) was the strongest risk factor, although transmission through fomites also seems possible.

An outbreak of tuberculosis (TB) in Italy involved 19 schoolchildren with active TB and 43 with latent infection. The source of the outbreak was a school assistant born in Italy who had a family history of TB. This outbreak highlights the need for maintaining clinical and public health expertise in countries with low TB incidence.

Supported by a specific act of the Italian Parliament.The committees and members of the Italian StudyGroup for the Di Bella Multitherapy Trials are asfollows. Research Coordinating Center: D. Greco,R. Raschetti, B. Caffari, F. Chiarotti, R. Da Cas, B.De Mei, G. Di Giovambattista, M. Maggini, F. Men-niti-Ippolito, S. Modigliani, P. Popoli, P. Ruggeri, S.Spila-Alegiani, C. Tomino, G. Traversa, P. Bruzzi, T.Gamucci. Steering Committee: G. Benagiano, D.Amadori, P. Bruzzi, E. Buiatti, E. Ciranni, F. Cog-netti, G. Colucci, P.F. Conte, G. Di Bella*, D. Greco,S. Iacobelli, F. Mandelli, E. Marubini, M. Massotti,S. Monfardini, F. Oleari, R. Raschetti, G. L. San-nazzari, L. Tomatis, U. Veronesi. (*Dr. G. Di Bella,the son of Dr. L. Di Bella, only participated in thefirst two meetings of the Steering Committee. Onmany occasions, he strongly disagreed with theperformance and results of the trials. No part ofthe current article has been discussed with orendorsed by Dr. G. Di Bella.) International ReviewBoard: P. Calabresi (Rhode Island), F. Cavalli (Bell-inzona, Switzerland), P. Kleihues (Lyon Cedex,France), J.G. Mc Vie (London, UK), H. Pinedo (Am-sterdam, The Netherlands), K. Sikora (Lyon Cedex,France), T. Tursz (Villejuif Cedex, France). Indepen-dent Endpoint Evaluation Committee: A. R. Bianco,R. Labianca, P. L. Rossi Ferrini, G. Simonetti, A.Sobrero. Investigators: Ancona—R. Cellerino, S.Antognoli, R. Berardi, R. Bracci, P. Lippe, F. Pulita;Aosta—F. Di Vito, D. Martinod, M. Musi; Avi-ano—A. Veronesi, R. Lazzarini; Bari—G. Colucci(Principal Investigator [PI]), V. Attolico, F. Giotta, M.Longo, E. Maiello; Bologna—S. Tura, F. Gherlin-zoni, M. Tani; Bolzano—H. Amor, P. Borona, F.Girardi, C. Graiff; Cagliari—G. Broccia, M. G. Co-rona, A. Desogus, V. Mascia, S. Pasqualucci; Ca-tania—G. Failla, M. R. Aiello, S. Cordio, P. Finoc-chiaro. Chieti—S. Iacobelli (PI), E. Melena, M. DeTursi, M. T. Scognamiglio, N. Tinari; Forli`—D.Amadori (PI), M. Maltoni, O. Nanni, F. Scardovi, P.Serra; Genoa—R. Rosso, F. Boccardo, A. Barp, T.Coli, M. Grimaldi; Milan—N. Cascinelli, L. Ascani,E. Bajetta, P. Bidoli, A. Cassata, D. De Candis, W.Giannessi, G. Procopio; Milan—S. Di Donato, A.Boiardi, D. Cerri, M. Eoli, A. Silvani; Milan—U.Veronesi (PI), M. Colleoni, N. Rotmensz; Na-ples—S. Monfardini (PI), G. Comella, A. De Mat-teis, A. Gravina, C. Gridelli, F. Perrone, M. R.Salzano, C. Sandomenico; Naples—C. Battista, G.Iodice, R. Fico, A. Nicchia; Padua—M. Lise, G. L.De Salvo, E. Di Lenardo, G. Iadicicco; Palermo—B.Agostara, I. Cafarelli; Perugia—M. Tonato, F.Radicchi, S. Sorbolini, O. Taschini; Pisa—P. F.Conte (PI), A. Carmignani, L. Del Mastro, A. Gen-nari, C. Orlandini; Potenza—L. Manzione, A. Di-nota, G. Lombardi; Reggio Calabria—G. Gasparini,M. G. Arena, M. Fanelli, F. Modafferi, A. Morabito;Rome—F. Mandelli (PI), P. Fazi, F. Mauro, M.Martelli, C. Ricci, M. Vignetti; Rome—F. Cognetti(PI), A. D’Alessio, S. De Marco, V. Ferraresi, T.Gamucci, D. Giannarelli, E. Magnani, P. Rellecati,E. M. Ruggeri, M. Zeuli; Turin—G. L. Sannazzari(PI), M. Borgognone, R. Chio`, A. Gasco, R. Ragona,M. Sacco, R. Soffietti, R. Verna, M. Tessa;Turin—A. Pileri; Trento—E. Galligioni, A. Lucenti,F. Moltrer, F. Paolazzi.The authors thank the Stabilimento ChimicoFarmaceutico Militare, Florence, Italy (Colonel G.Muzzi, Director), for the production of the melato-nin tablets and retinoid solution and the Group forthe supervision and control of custom-made drugsof the Istituto Superiore di Sanita`, Roma (E. Cir-anni, Director; R. Alimenti, S. Alimonti, G. Cavaz-zutti, L. Gagliardi, B. Gallinella, G. Incarnato, F. LaTorre, A. Mosca, G. Multari, L. Turchetto, L. Valvo).Address for reprints: Giuseppe Traversa, M.D., De-partment of Epidemiology and Biostatistics, IstitutoSuperiore di Sanita`, Viale Regina Elena 299, 00161Rome, Italy.Received April 26, 1999; revision received July 22,1999; accepted July 29, 1999.

A large, randomized, placebo-controlled clinical trial in Italy on two three-component pertussis vaccines, given as DTaP in infancy, one manufactured by SmithKline and Beecham (SB) and one by Chiron Biocine (CB), found each vaccine to be 84% efficacious through the average age of 24 months. The cohort of children envolled in the trial was followed with unmodified case ascertainment procedures for nine additional calendar months, during which partial unblinding occurred, for the unvaccinated randomized group. For the DTaP groups, the specific vaccine assignment remained double-blinded throughout the entire additional observation period. Pertussis was defined as paroxysmal cough lasting at least 21 days and confirmed by culture or serology. In the additional 9 months the observed absolute efficacy was 78% (95% CI, 62–87%) for SB DTaP vaccine and 89% (95% CI, 79–94%) for CB DTaP. The relative risk of developing pertussis in SB DTaP recipients compared to CB DTaP vaccinees was 1.99 (95% CI, 1.13–3.51). By combining observations from the initial and additional follow-up periods, the overall observed vaccine efficacy through an average age of 33 months of SB DTaP was 80% and of CB DTaP, 85%

Titers of serum antibody and cell-mediated immunity (CMI) to Bordetella pertussis antigens were assessed in a cohort of Italian military school students for whom the coverage of pertussis vaccination was low. The overall prevalence of IgG antibody above the minimum level of detection (MLD) was 71.6% for pertussis toxin (PT), 81% for pertactin (PRN), and 99% for filamentous hemagglutinin (FHA). Levels of IgA antibody to PT above the MLD were detected in 15.9% of the study participants. CMI to FHA, PRN, and PT was positive in 97%, 100%, and 82% of tested individuals, respectively. Only 9.7% of the participants had neither antibody nor CMI specific to B. pertussis antigens. In the 5-month clinical, microbiological, and serological follow-up conducted during a high-risk period of pertussis, no cases of pertussis were detected. These data, in particular CMI, demonstrate that most Italian young adults are specifically primed against B. pertussis, which should be taken into consideration when future policy on pertussis vaccination is being made in Italy.

After >10 years without detection of any cases of wild virus-associated poliomyelitis, a large outbreak of poliomyelitis occurred in Albania in 1996. A total of 138 paralytic cases occurred, of which 16 (12%) were fatal. The outbreak was due to wild poliovirus type 1, isolated from 69 cases. An attack rate of 10 per 100,000 population was observed among adults aged 19-25 years who were born during a time of declining wild poliovirus circulation and had been vaccinated with two doses of monovalent oral poliovirus vaccines (OPVs) that may have been exposed to ambient temperatures for prolonged periods. Control of the epidemic was achieved by two rounds of mass vaccination with trivalent oral poliovirus vaccine targeted to persons aged 0-50 years. This outbreak underscores the ongoing threat of importation of wild poliovirus into European countries, the importance of delivering potent vaccine through an adequate cold chain, and the effectiveness of national OPV mass vaccination campaigns for outbreak control.

Background Concern about both safety and efficacy has made the use of whole-cell pertussis vaccines controversial. In some European countries, including Italy, the rate of vaccination against pertussis is low. Methods We conducted a double-blind trial in Italy in which infants were randomly assigned to vaccination at two, four, and six months of age with an acellular pertussis vaccine together with diphtheria and tetanus toxoids (DTP); a DTP vaccine containing whole-cell pertussis (manufactured by Connaught Laboratories); or diphtheria and tetanus toxoids without pertussis (DT). The acellular DTP vaccine was either one containing filamentous hemagglutinin, pertactin, and pertussis toxin inactivated with formalin and glutaraldehyde (SmithKline Beecham) or one with filamentous hemagglutinin, pertactin, and genetically detoxified pertussis toxin (Chiron Biocine). Pertussis was defined as 21 days or more of paroxysmal cough, with infection confirmed by culture or serologic testing. Results The efficacy of eac...

Background The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy. Methodology/Principal Findings The reference population comprises around 3 million infants vaccinated in Italy in the study period 1999–2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1–23 months were identified through the death certificates. Vaccination history was retrieved from immunisation registries. Association between immunisation and death was assessed adopting a case series design focusing on the risk periods 0–1, 0–7, and 0–14 days after immunisation. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR = 1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0–7 and 0–14 were 2.0 (95% CI 1.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR = 2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined. Conclusions The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates in Germany. The limited increase in RRs found in Italy appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age.

A sample of 393 Albanian refugees, including both children and adults, was tested for serological HAV, HBV, HDV and HCV markers. A high prevalence of infection with both the hepatitis A and B viruses was found, while HDV and HCV infections were uncommon. The overall prevalence of anti-HAV was 96%; it was very high in children 0-10 years, suggesting that HAV infection is largely acquired during childhood and that poor ambiental conditions influence the spreading of this viral infection. One or more serological markers of HBV infection were found in 295 Albanians (75%), confirming the endemic nature of this virus in the Albanian community. The overall prevalence of HBsAg was 19%, and the carrier rate was higher in males than in females. The high HBsAg prevalence among children suggests that HBV infection is usually acquired in early childhood. The serological data obtained in the Albanian sample examined clearly indicate the urgent need for measures to reduce the incidence of HAV and HBV infections and to avoid the further spread of HDV and HCV infections. Finally, the high prevalence of type B hepatitis indicates the necessity of vaccination against HBV for all risk groups and for all children at birth.

OBJECTIVE To describe the epidemiology of AIDS-associated Kaposi's sarcoma (KS) in Italy between January 1982 and September 1991. DESIGN To make this study comparable with previous research from other countries, statistical analysis of data from the Italian AIDS surveillance system was performed. METHODS Odds ratios (OR) and 95% confidence intervals (CI) were used to examine the association between several characteristics of AIDS cases and the presence of KS as the presenting clinical manifestation of AIDS. Trends in the frequency of AIDS-associated KS were also estimated. RESULTS Of the 10,584 Italian AIDS cases reported up to September 1991, 720 (6.8%) had KS as the presenting clinical manifestation. In comparison with intravenous drug users (IVDU), of whom 2.6% had KS, homosexual or bisexual men had a nearly 10-fold higher risk of KS (OR, 10.2; 95% CI, 8.2-12.8), homosexual men who were also IVDU a nearly fourfold increased risk (OR, 4.4; 95% CI, 3.0-6.6) and heterosexuals a 2.6-fold risk (95% CI, 1.7-3.7). Men were more likely to have KS than women. The percentage of new AIDS cases with KS recorded each year in Italy declined from 12.0% in 1982-1986 to 5.8% in 1990-1991, a significant relative decrease of 19.0% per year (95% CI, 14.1-23.6%). The decline was observed among both IVDU (20% per year) and homosexual or bisexual men (11.4% per year). The frequency of KS was similar across age groups within each transmission category, whereas geographical differences emerged in the prevalence of AIDS-associated KS, especially among IVDU. CONCLUSIONS Our data on the epidemiology of AIDS-associated KS in Italy are similar to reports from North America and Europe, which show that KS is more common among individuals who acquired HIV infection by sexual transmission rather than parenterally, and that the incidence of this neoplasm is declining over time. The still poorly understood aetiology of AIDS-associated KS needs to be investigated further.

The immunity against poliomyelitis in a representative sample of the Albanian population recently immigrant to Italy was evaluated. A significant number of the subjects examined lacked protective antibodies against one or more polioviruses. The most prevalent seronegativity related to poliovirus type 3 (41.3%), followed by poliovirus type 1 (21.5%). This result was more consistent in the younger age groups. Our data suggest the hypothesis that this problem arises from the use of a vaccine of discontinuous efficacy caused by defective preservation. A poliovaccine booster dose for all emigree subjects aged less than 15 years is suggested.

To assess the magnitude of the AIDS epidemic in the Italian adolescent (13-19 years) and young adult (20-24 years) age groups, data on AIDS cases notified to the AIDS Operational Centre as of 31 March 1990 were used. Of the 6068 reported AIDS cases, 0.7% occurred among adolescents and 15.7% among young adults. Among adolescents most cases were haemophiliacs (45.4%), while among young adults, drug use was the most frequently reported mode of transmission (87.5%). Females were more likely than males to contract the disease through the heterosexual contact in both the adolescent (20.0% vs 0%) and in young adult (15.1% vs 0.7%) age groups. Among young adults a geographical trend was present with a decrease in case rates from north to south, while for adolescents the rates were higher in northern and southern than in central Italy. If the incidence of AIDS is to be reduced in Italy, further efforts should be made to target the adolescent age group, since many of the young adult cases are likely to have resulted from HIV infection during adolescence.

Recurrence of adverse events, the effect of site of injection, and concurrent administration of oral polio vaccine (OPV) and hepatitis B vaccine (HBV) on reactogenicity were assessed in recipients of two acellular pertussis vaccines given in combination with diphtheria and tetanus toxoids (DTaP), one whole-cell DTP vaccine (DTPwc) and one DT vaccine during a double blind, randomized, controlled clinical trial. Local and systemic side reactions were more likely to recur after the administration of DTaP and DT compared with DTPwc. In all vaccine groups, injection in the buttock was associated with a lower rate of common adverse events compared with injection in the thigh, while simultaneous administration of OPV and/or HBV did not increase the risk of onset of side reactions.

The implementation of surveillance systems for HIV and of large cohort studies have allowed for the construction of models that more accurately describe the HIV epidemic. This review focuses on changes in the epidemiological pattern, and the effect of changes in behaviour and of antiretroviral therapy.

In late May 1994, following reports of an outbreak of group A beta-haemolytic streptococcus (GAS) in the United Kingdom, the Istituto Superiore di Sanità (ISS) set up a surveillance system for systemic invasive GAS disease. The surveillance system was als

Between April and November 1996, a large outbreak of polio occurred in Albania, which had reported to be free of polio since 1985. Although Albania had not reported polio in that interval, the risk of introduction and circulation of wild poliovirus had in

The past ten years have seen a resurgence in reports of severe group A streptococcal infections (GAS), including streptococcal toxic shock syndrome (STSS) and necrotizing fasciitis1,5. This report summarizes the situation of systemic GAS infections observed over a 2-year period (1994–1995) in Italy.

A prospective, multicenter, open study of fluconazole prophylaxis was performed in AIDS patients to evaluate the efficacy and toxicity of the drug in preventing relapses of esophageal candidiasis. To this aim, 99 AIDS patients who presented a first episode of clinically and microbiologically confirmed esophageal candidiasis were enrolled in eleven clinical centers scattered throughout the Italian territory. After resolution of this initial esophagitis, all subjects were given fluconazole, 100 mg/die, and followed up for a 6 month period. Only 7 out of the 99 patients enrolled had a relapse of Candida esophagitis, during a mean follow-up period of 138.5 days. All relapsing patients had CD4+ cell number < 100/microliters at baseline. Mild side effects were reported in only eight patients. However, 14 of the 27 subjects from whom serial serum samples were available became (12) or remained (2) antigenemic during fluconazole prophylaxis, independently from relapse, suggesting the persistence of tissue-invasive, proliferating Candida cells. Overall, the data of this study suggest a beneficial effect of prophylactic maintenance therapy with fluconazole against Candida esophagitis, particularly in the population with > 100 CD4+/microliters. However, the data on Candida antigenemia in these patients invite the consideration of a relative inefficiency of the drug to eradicate the microrganism from the esophageal tissue

Researchers gathered data from the National Registry of AIDS in Italy to examine the effect breast feeding has on the incubation time for AIDS in 117 vertically infected children. 36 children received breast milk and 64 were bottle fed. No perinatal feeding data existed in the registry for the remaining 17 children. There was a significant difference between the median incubation periods for the 36 breast fed (19 months) and 64 bottle fed (9.7 months) children (p=.003). An overlap in the incubation curves took place shortly before 60 months however. Further the breast fed children had a longer survival rate than the bottle fed children (Breslow p=.01; Mantel-Cox p=.003). From 198 when the 1st case occurred to 1986 breast feeding and bottle feeding patterns remained stable but beginning in 1987 the frequency of breast feeding declined significantly (p

Sexually Transmitted Diseases (STD) surveillance has caught the attention of the Italian public health authorities during the past decades. The spread of HIV infection increased the awareness of the need for a better STD surveillance system. This paper reports a retrospective survey of STD clinics in Italy, intended to form an epidemiological base for further development of STD surveillance. The data for 1986-87 and 1988 on a predefined set of diseases, all of them sexually transmitted, were collected from 85 of 127 centres contacted. The data obtained offer the first national figures for some STD not included in the statutory notification list, such as chlamydial infection, herpes and genital warts, as well as HIV infections. Those data show an increase in time frequencies. For gonorrhoea and syphilis, it was possible to compare our data with statutory notifications, showing a large gap between notified and reported cases. This gap is not stable in time (increasing in time) or in geographical area (increasing from north to south).

In 1992-94, a randomized, double blind, placebo-controlled clinical trial of two acellular and one whole-cell pertussis vaccines was conducted in Italy. Each acellular vaccine (one manufactured by SmithKline Beecham [SB] and one by Chiron Biocine [CB]) contained filamentous hemagglutinin, pertactin and inactive pertussis toxin, the latter being detoxified by formalin and glutaraldehyde in SB DTaP and genetically detoxified in CB DTaP. Primary immunization at 2, 4 and 6 months of age provided an efficacy for each DTaP of 84% in preventing confirmed pertussis of 21 or more days of paroxysmal cough, over an average of 17 months of follow-up. The incidence rate ratio (IRR) of pertussis in recipients of SB and CB vaccines was 1.0 with 37 cases in 4,481 children and 36 cases in 4,452, respectively. In 1995, during additional blinded follow-up of the same cohorts through September 30, a total of 53 pertussis cases have been diagnosed in DTaP recipients through an average age of 35 months. Thirty-five cases of confirmed pertussis occurred in SB DTaP recipients in the nine-month period and 18 cases in CB DTaP recipients. Although initially both vaccines exhibited equivalent high efficacy, in a further period of observation the incidence in CB DTaP recipients was significantly lower. Table

To the Editor. —We would like to comment on the Medical News & Perspectives report inThe Journal1on the need for a national ethics advisory board in the United States. It is unclear to us why the clinical trial of pertussis vaccines in Italy (Progetto Pertosse) is automatically assumed to have inadequately protected the rights of human subjects. The report of the meeting of the Congressional Biomedical Research Caucus infers that conclusions of impropriety have been reached or there is wide dissenting opinion in Italy on the conduct of this project. As such, the scientific readership ofJAMAhas not had the opportunity to consider other views on the project from researchers of the Istituto Superiore di Sanita (ISS) (the technical and scientific body of the Italian Health System) who conducted the project or members of ethics, pharmacoepidemiologic, or pediatric groups in Italy. While there is no doubt

Objective. —To assess the long-term effectiveness of zidovudine (AZT) in patients with acquired immunodeficiency syndrome (AIDS). This assessment has never been adequately done because controlled clinical trials were stopped early and survival comparisons were made with historical controls. Design. —Nonrandomized contemporary observational study of patients treated and not treated with zidovudine. Setting. —Twenty-three AIDS treatment centers throughout Italy that reported cases to the National Registry of AIDS Cases between July 1987 and March 1988. Patients. —One hundred fifty-nine zidovudine-treated and 112 untreated patients with AIDS, the majority of whom had acquired human immunodeficiency virus (HIV) infection through intravenous drug use. Outcome Measures. —Median survival and 1- and 2-year survival for treated and untreated groups, as estimated using the Kaplan-Meier method. Cox proportional hazards regression analysis was also used to identify independent predictors of survival among the variables studied. Results. —Patients were similar with respect to CD4/CD8 ratio, age, sex, clinical and immunological status at diagnosis, and source of HIV infection. After 24 months, survival was 45.9% (95% confidence interval [Cl], 36.1% to 55.7%) in the treated group and 20.5% (95% Cl, 12.6% to 28.3%) in the untreated group, with median survival of 21.2 and 9.6 months, respectively. Conclusions. —Possible biases of this study include imperfect matching for clinical status and better overall medical care of treated patients. Nevertheless, we believe that the observed differences in survival were primarily due to zidovudine treatment. ( JAMA . 1992;267:1232-1236)

A person to person outbreak of hepatitis A is described: 90 cases of hepatitis A occurred in a small town in Calabria, southern Italy; all cases were under 18 years of age with the highest age-specific incidence rate in the 6-10 year age group. Transmission was identified by tracing close contacts with other incubating or active cases; only eight out of 90 cases were not identified as having a very probable or possible contact with an infecting case. Transmission was high between family members leading to a secondary family attack rate of 51% in children under 16. An enteric disease educational campaign was carried out together with IgG and no cases of hepatitis A were reported in the two years following the investigation.

A survey of the incidence of bacteraemia and the use of intravenous (IV) devices among 10,616 surgical patients was performed in 42 hospitals in eight countries. It was found that 63 per cent of the patients surveyed had an IV device inserted at some time during their hospital stay, with national variations between 40 and 99 per cent. The incidence of device-related thrombophlebitis was 10.3 per cent, with national variations between 7.8 and 28.4. Among the surgical patients not given IV therapy, 1.5/1000 had a bacteraemia, 0.5/1000 of them hospital-acquired. The corresponding figures for patients with a peripheral but no central IV device were 6.9 and 3.7, and for patients with a central venous catheter (CVC) 59.0 and 44.8, respectively. Even though there was a strong correlation between the incidence of bacteraemia and certain diagnoses there was also an independent correlation between it and CVCs or peripheral IV lines. No correlation was demonstrated between the number of catheter days per site for patients with a peripheral IV device, and hospital-acquired bacteraemia. This may be due to the low mean number of catheter days per site that was observed. There was a large and not easily explained national variation in the incidence of bacteraemia in patients with CVCs of between 16 and 108/1000.

In 1983 a national prevalence survey was conducted in Italy to discover the general distribution of infection among patients in public hospitals. Thirty-four thousand, five hundred and seventy-seven acute patients were surveyed in 130 hospitals spread throughout the country: 6668 patients (19·3%) had an active infection at the time of the survey; the infection was hospital-acquired in 2361 (6·8%) and community-acquired in 4307 (12·5%). The urinary tract was the site most frequently involved in hospital infection (30·2% of patients with hospital-acquired infection). The respiratory tract was the site most often involved in community infections (35·7% for the lower tract and 9·1% for the upper). Hospital-acquired infections were more frequent in intensive care units (12·4%) and in geriatric (11·6%), orthopaedic (8·2%) and surgical wards (7·6%). The prevalence of urinary tract infection was 10·4% among the 9·4% of patients who were catheterized compared with a prevalence of 2·6% in the uncatheterized. Thirty-five point five per cent of patients were receiving an antimicrobial on the day of the survey.