The role of hepatitis B vaccine challenge dose in patients with underlying health conditions.

We have evaluated the immunological response to Hepatitis B virus (HBV) booster vaccine dose in 129 adults with underlying diseases in comparison with 694 subjects at occupational risk of infection, who have previously completed the primary series and resulted with anti-HBs <10 mIU/mL. After booster dose, 60.5% of the patients with underlying diseases and 14.8% of the subjects at occupational risk resulted seronegative. By comparing two groups, rate of subjects with anamnestic response was higher in at occupational risk group respect to that at risk for medical conditions (OR: 5.99 [95%IC, 3.81-9.41], p < .001). This difference was associated to gender (males/females: OR: 0.619 [95%IC, 0.421-0.910], p = .015) and age (better response for younger people, p = .011).

Utility of serological screening for measles, mumps and rubella in immunocompromised patients.

Marchi et al. in their article (Measles in pregnancy: a threat for Italian women? Hum Vaccin Immunother. 2019 Jun 20:1-3) observed that 96.9% of pregnant women were positive for anti-measles IgG (with a higher risk of contracting measles in those aged 19-29 years) emphasizing the importance of serological screening before pregnancy. We evaluated seroprotection/seropositivity rates to Measles, Mumps and Rubella in 324 adults with an acquired immune-deficiency needing an immunization program. We found that younger patients (20-29 years) had a seroprevalence below 85%. Overall, a relevant proportion (21.6%, 54/250) of patients was susceptible to at least one infection needing immunization. Our results confirm the usefulness of proper strategies for identifying individuals susceptible to vaccine-preventable infections and protecting them through vaccination.

Practice parameters for the diagnosis and treatment of anal intraepithelial neoplasia (AIN) on behalf of the Italian Society of Colorectal Surgery (SICCR).

Squamous cell carcinoma (SCC) of the anus is a human papilloma virus (HPV) related malignancy that is preceded by anal intraepithelial neoplasia (AIN) making this cancer, at least theoretically, a preventable disease. In the past 10 years the diagnosis, management and nomenclature of AIN has dramatically changed. Increased life expectancy in human immunodeficiency virus (HIV) positive patients due to highly active antiretroviral therapy (HAART) has caused an increase in the incidence of SCC of the anus. While many experts recommend screening and treatment of anal high-grade squamous intraepithelial lesion (HSIL), there is no consensus on the optimal management these lesions. Therefore, there is a need to review the current evidence on diagnosis and treatment of AIN and formulate recommendations to guide management. Surgeons who are members of the Italian Society of Colorectal Surgery (SICCR) with a recognized interest in AIN were invited to contribute on various topics after a comprehensive literature search. Levels of evidence were classified using the Oxford Centre for Evidence-based Medicine of 2009 and the strength of recommendation was graded according to the United States (US) preventive services task force. These recommendations are among the few entirely dedicated only to the precursors of SCC of the anus and provide an evidence-based summary of the current knowledge about the management of AIN that will serve as a reference for clinicians involved in the treatment of patients at risk for anal cancer.

Herpes Zoster: the rationale for the introduction of vaccination in Italy.

Herpes Zoster (HZ) and its main complication, post-herpetic neuralgia (PHN), represent an important public health issue because of their relevant burden within older adult population and the actual suboptimal therapeutic management of the diseases. Incidences of HZ and PHN are comparable all over the world and are closely related with the population age. Epidemiological data collected in Italy about HZ and its complications confirmed the trend registered in North America and Europe. Moreover HZ related burden is exacerbated by a significant economic impact related to both direct and indirect costs. Since 2006 a live, attenuated varicella zoster virus vaccine, that contains VZV Oka strain [Zostavax, Merck & Co., Inc.], was licensed for the prevention of HZ and PHN in adults aged ≥ 60 years. Since 2011, the licensure has been extended to adults between 50 and 59 years. The vaccine has demonstrated a good immunogenicity, efficacy and safety profiles in two pivotal phase III clinical trials and the effectiveness was further confirmed after vaccine licensure. Pharmaco-economic studies concluded that HZ vaccine is cost-effective in most European countries and generally supported the economic value of this vaccination. The vaccine is actually recommended in USA, Canada and several European countries. The opportunity to reduce the burden of these diseases by the recommendation of HZ vaccination have been evaluated and suggested also in our Country and some Regions have been recently introduced the vaccine in their immunization plan. If the good results, already obtained with HZ vaccine in other countries, will be confirmed by these Italian pilot experiences, vaccination programs should be made uniform in all Country in order to ensure an equitable offer of this important preventive tool.

Rs12979860 and rs8099917 single nucleotide polymorphisms of interleukin-28B gene: simultaneous genotyping in caucasian patients infected with hepatitis C virus.

INTRODUCTION: Recent studies have demonstrated the role of the interleukin 28B (IL28B) polymorphisms in predicting treatment induced and spontaneous clearance from Hepatitis C virus (HCV) infection, suggesting the possibility of tailored therapy in HCV infected patients. Genome-wide association studies have shown that single nucleotide polymorphisms (SNPs) near IL 28B gene on chromosome 19 are strong predictors of sustained virologic response (SVR) to pegylated interferon and ribavirin. This study was aimed at analyzing the co-prevalence of two common and clinically significant SNPs in a cohort of Ligurian patients. METHODS: Two SNPs (rs12979860, rs8099917) were genotyped in the IL28B locus from 175 DNA samples collected from HCV-infected consecutive patients in a Laboratory of Liguria Region, northern Italy. A real-time polymerase chain reaction in a Corbett Research Termocycler (Rotor Gene 3000A) by fluorescent probes (Fast Set IL 28B, Arrow Diagnostics) was used for the detection, according to the manufacturer's instructions. RESULTS: Carriers of rs12979860CT genotype predominated (87/175, 50%), homozygotes for allele C were 68/175 (39%) and the remaining were homozygotes for IFN-resistant allele T (11%). As for the rs8099917 SNP, genotypes were thus distributed: 96/175 (55%) carried the rs8099917 TT genotype, whereas 70/175 (40%) and 9/175 (5%), were heterozygotes or homozygotes for the G allele. The variants rs12979860CC and rs8099917TT were found in 39% and 54% of overall patients with HCV genotype 1, respectively. The combined assessment of examined SNPs resulted in three most prevalent genotypes (rs12979860CC/rs8099917TT, rs12979860CT/rs8099917TG and rs12979860CT/rs8099917TT) with a frequency of 35%, 31% and 18%, respectively. DISCUSSION: Recent findings demonstrated that in carriers of rs12979860CT the determination of additional genotype of rs8099917 SNP could significantly improve the prediction of SVR. In our study cohort carriers of rs12979860CT represented 50% of all patients, who could take advantage with respect to SVR prediction by further determination of the rs8099917 SNP. The simultaneous genotyping of two IL28B SNPs should thus be recommended in HCV infected patients prior to treatment initiation.

Pneumococcal vaccination in adults: rationale, state of the art and perspectives.

Streptococcus pneumoniae (SP) is a leading cause of morbidity and mortality worldwide. Despite the availability, since the early 1980s, of a 23-valent pneumococcal polysaccharide vaccine (PP V23), its recommendation and increased use in the last decades, and the indirect benefits against invasive pneumococcal diseases following the pediatric immunization strategies with the 7-valent pneumococcal conjugate vaccine (PCV7), pneumoccal diseases, particularly Community Acquired Pneumonia (CAP), still remain a substantial burden among older adults in Western countries. The recent availability on the market of a second generation of pneumococcal conjugate vaccines, with an enlarged spectrum of protection against some serotypes not included in the PCV7 (i.e., the 13-valent pneumococcal conjugate vaccine--PCV13), opens new interesting perspectives for improving the control of this significant health-care issue among the entire population. The most interesting and up-dated epidemiological data regarding the impact of SP in adults and the elderly in Western countries, together with the available evidence concerning the efficacy and effectiveness of the PPV23 in the same population, are reported and discussed below.

@Prevention: a website project for prevention in the healthcare setting.

In the field of prevention, Internet websites and their related instruments constitute valuable tools for healthcare facilities, and particularly for Local Healthcare Authorities (LHA). As yet, however, their undoubted potential remains largely unexploited. Many LHA websites currently operating in Italy are organized in such a way that they fail to make adequate use of this precious resource. Indeed, communication regarding prevention is all too often limited to the simple reproduction of information and indications in a static and heterogeneous manner, so much so that it resembles a mere "online notice-board". The aim of the present research was to analyze the current situation and the various innovative proposals that have been made, in order to construct a more effective website model that could be used nationwide. To this end, the research was carried out through a two-pronged approach: on the one hand, all 190 LHA websites in Italy were analyzed; on the other, a questionnaire was administered to a sample of habitual users of the most modern and widespread social network, Facebook. Analysis and elaboration of the data gathered led to the creation of the model "@Prevention". This project is intended to introduce an innovative perspective into the field of online communication for healthcare prevention by providing a highly useful tool for the LHA, healthcare workers and, obviously, citizens.

Hospital-acquired infections and leading pathogens detected in a regional university adult acute-care hospital in Genoa, Liguria, Italy: results from a prevalence study.

BACKGROUND: A prevalence study aimed to update the epidemiological scenario of Hospital-Acquired Infections (HAI) was performed at the San Martino University Hospital of Genoa, the Regional Reference Adult-care Center in Liguria, Italy, with more than 1300 beds. MATERIALS AND METHODS: The investigation was performed in all the wards, except the Psychiatric Units, between 19th March and 6Ih April, 2007, using a one-day monitoring system for each ward. International standardized criteria and definitions for the surveillance of HAI were used for the collection of data, which were recorded in specific software for subsequent consolidation, analysis and quality control. RESULTS: The hospital infection control staff actively monitored 912 inpatients: a total of 84 HAI among 72 patients were diagnosed, with an overall prevalence of infections and affected cases of 9.2% (95% CI: 7.3-11.1) and 7.9% (95% CI: 6.1-9.7), respectively. Urinary Tract Infections (UTI) (30.9%), Respiratory Tract Infections (RTI) (28.6%) and Blood Stream Infections (BSI) (21.4%) were found to be the most frequent infections. As expected, both specific prevalence and localization of HAI varied considerably between wards, with the highest values recorded in Intensive Care Units (ICU) and in Functional Rehabilitation wards. RTI (26.3%) and BSI (13.2%) were found primarily represented in ICU, while the highest values of UTI (13.3%) were registered in Functional Rehabilitation Units. Enterococcus spp. (16.8%), Candida spp. (14%), Pseudomonas spp. (12.2), Staphylococcus aureus (10.7%), Escherichia coli (10.3%) and Coagulase-negative staphylococci (CNS) (9.3%) were the most frequent pathogens isolated. The overall rate of administration of antibiotics was 55.3% and penicillin (26.7%), cephalosporins (22.8%) and fluoroquinolones (17.9%) were found to be the leading antibacterial administered. CONCLUSION: Results of the present study have been, and are currently, used for orientating surveillance and control hospital policies, planning activities according to a rational and evidence-based approach.

Evaluation of microbial contamination of air in two haematology departments equipped with ventilation systems with different filtration devices.

BACKGROUND: Nosocomial infections (NI) are above all due to health-care workers practices, but also the contamination of the environment could lead to their rise in health-care facilities. Introduction. In the last years, the incidence of NI has increased due to a substantial rise in the number of immuno-compromised patients. These patients are often gathered in hospital areas declared at "high risk" of infection such as Hematology and Bone Marrow Transplant ward. In this study, we evaluated microbial contamination of the air in two divisions with high risk patients, focusing on the validity of the air system with correlation to the presence or not of the HEPA absolute filters. METHODS: An environmental surveillance study has been carried out in two Divisions of Haematology, in two different Hospitals. Investigations have been performed by sampling air and by analyzing bacterial and fungal growth on microbiology plates after an incubation period. RESULTS: Unit A, without HEPA filters in the ventilation systems, showed a gradual increase in the bacterial load 20 and 60 days after cleaning of the ventilation system. Mycetes and Aspergilli were not present in basal conditions, at 20 or 60 days after decontamination. Unit B, equipped with HEPA filters placed at the inlet vents, showed extremely low values of the bacterial load either in basal conditions or upon inspection 60 days after cleaning. No mycetes were present. DISCUSSION: From the results obtained, it was evident that following the cleaning operation, the quality of the air is excellent in both types of equipment, since no mycetes were present and the bacterial load was < 20 CFU/mc in all the sites tested. However, although in subsequent controls mycetes were absent in both types of equipment, a great difference in the suspended bacterial load was found: Unit B was close to sterility whereas in Unit A a progressive increase was observed.

Decline in pneumonia and acute otitis media after the introduction of childhood pneumococcal vaccination in Liguria, Italy.

The effect of the pneumococcal conjugate vaccine immunization programme on pneumococcal-associated or potentially pneumococcal-associated hospital admissions in the Italian region of Liguria was assessed. Hospital admission rates were compared in subjects belonging to birth cohorts before and after the introduction of widespread immunization for 0 - 2-year old children with a seven-valent conjugate vaccine (PCV7). Significant reductions in hospitalization rates for all-cause and pneumococcal pneumonia and for acute otitis media were observed in subjects born after widespread uptake of the vaccine. The preventive fraction (a measure of vaccine effectiveness) ranged from 15.2% for all cause pneumonia to 70.5% for pneumococcal pneumonia. This study contributes to the growing body of information that supports the beneficial effect of PCV7 vaccination.

Safety and immunogenicity of two influenza virus subunit vaccines, with or without MF59 adjuvant, administered to human immunodeficiency virus type 1-seropositive and -seronegative adults.

The objective of this study was to evaluate and compare both the safety and tolerability and the humoral and cell-mediated immune responses for two influenza virus subunit vaccines, one with MF59 adjuvant (Fluad) and one without an adjuvant (Agrippal), in healthy and in human immunodeficiency virus type 1 (HIV-1)-infected adult individuals. To achieve this aim, an open, randomized, comparative clinical trial was performed during the 2005-2006 season. A total of 256 subjects were enrolled to receive one dose of vaccine intramuscularly. Blood samples were taken at the time of vaccination and at 1 and 3 months postvaccination. A good humoral antibody response was detected for both vaccines, meeting all the criteria of the Committee for Medical Products for Human Use. After Beyer's correction for prevaccination status, Fluad exhibited better immunogenicity than Agrippal, as shown from the analysis of the geometric mean titers, with significant differences for some virus strains; however, no definitive conclusions on the clinical significance of such results can be drawn, because the method used to estimate antibody response is currently nonstandard for influenza virus vaccines. Significant induction of an antigen-specific CD4+ T-lymphocyte proliferative response was detected at all time points after immunization, for both the vaccines, among HIV-1-seronegative subjects. This was different from what was observed for HIV-1-infected individuals. In this group, significance was not reached at 30 days postvaccination (T30) for those immunized with Agrippal. Also when data were compared between treatment groups, a clear difference in the response at T30 was observed in favor of Fluad (P = 0.0002). The safety profiles of both vaccines were excellent. For HIV-1-infected individuals, no significant changes either in viremia or in the CD4+ cell count were observed at any time point. The results showed good safety and immunogenicity for both vaccines under study for both uninfected and HIV-1-infected adults, confirming current recommendations for immunization of this high-risk category.

Influenza and respiratory syncytial virus in infants and children: relationship with attendance at a paediatric emergency unit and characteristics of the circulating strains.

A study was carried out on 2,696 Italian children, aged 0-14 years. The goals were: (1) to define the age-related impact of acute respiratory infections (ARI), measured as the risk of attendance at the Paediatric Emergency Room, (2) to better define the importance and proportion of influenza and respiratory syncytial virus (RSV) infections and (3) to acquire deeper knowledge of the influenza strains circulating in infants and children. A standardised emergency unit attendance risk (EUAR) was calculated, by age group for ARI. Specific EUARs were also calculated for the two pathogens. Pharyngeal swabs were tested by polymerase chain reaction (PCR) for influenza and RSVs. Isolation in Madine-Darby canine kidney cells (MDCK) and Hep cells, haemagglutination inhibition (HI) testing and HA1 gene sequence analysis were performed for influenza viruses. Most of the patients enrolled were aged 0-5 years, 1,139 (84.6%) and 1,061 (78.5%) in the two seasons, respectively. The most represented age class was that of 1 year olds (331 cases in 2001-2002 and 301 in 2002-2003). The highest EUAR for ARI was in patients aged 0-3 years (16.8 and 12.9 during the two seasons). The same was observed on calculating this risk by specific pathogens: 17.4 and 5.5 for influenza and 13.0 and 12.7 for RSV. Virological analysis was performed on 2,696 samples, 595 of which proved positive (22%). The highest number of isolates (326) came from patients aged 1-3 years. RSVs were more often identified than influenza viruses in infants aged up to 1 year (32 vs. 20 isolates). Of 265 strains isolated in 2001-2002, 103 were RSVs (87 type A, 16 B) and 162 were influenza (90 type A, 72 B). HI showed that influenza B viruses were related to two lineages, B/Victoria/2/87 (32%) and B/Yamagata/16/88 (68%). Of 330 strains isolated in 2002-2003, 102 were RSVs (91 type A, 11 B) and 228 were influenza viruses (220 type A, 8 B). A/H3N2 strains belonged to two clusters, A/Panama/2007/99-like and A/Fujian/411/02-like, a new variant. This paper discusses the possible role of the identified flu strains in determining EUARs among the population by age class.

Molecular epidemiology and case-control approaches for management of an outbreak of hepatitis A in Liguria, Italy.

INTRODUCTION AND METHODS: Hepatitis A remains an important public health problem in low endemicity areas, because of the social and economic high burden of cyclical outbreaks. In this study we described an outbreak of HAV infection occurred in the city of Genoa and in its proximity and the viral circulation in the post-epidemic period. In order to identify risk factors associated to the illness and to determine the source of infection and the dynamics of virus evolution, we conducted an epidemiological and molecular investigation by a case-control study and by sequence analysis of high variable regions of the genome. RESULTS: From May to October 2005, 58 HAV hepatitis cases were notified. The case-control study showed that beach establishment attending is strongly associated with HAV hepatitis (OR = 24.5, p-value < 0.01), at multivariate analysis. The profile of epidemic curve, the clinical onset of primary cases who occurred in few weeks and the geographic distribution of cases clearly indicated a common exposure to a point source: the outbreak can be probably associated with a contaminated food product dispensed in the affected area. The outbreak has been mainly caused by a single variant, confirming the common exposure to a point source; this variant previously circulated within homosexual man (MSM) network in Northern Europe. During the outbreak and in the following months, different variants originating from Southeast Asia, Southern America and Northern Africa, have co-circulated: all these cases were related to international travel and none of these had determined secondary cases. DISCUSSION: The epidemiological picture of hepatitis A in Liguria is characterized by a wide heterogeneity of circulating HAV strains. This pattern could be associated with the increase of imported cases and transmission within network of persons with similar risk factors. Molecular approach coupled to descriptive and analytical epidemiological studies appeared un-replaceable tools for management and control of HAV outbreaks, because of their capacity to recognize infection origin, transmission patterns and dynamics of virus evolution.

Performance testing of two new one-step real time PCR assays for detection of human influenza and avian influenza viruses isolated in humans and respiratory syncytial virus.

INTRODUCTION AND METHODS: Two real time one-step RT-PCR assays were developed for simultaneous detection and typing of influenza A and B viruses and detection of Respiratory Syncytial Virus (RSV). As regard influenza, primers were designed to amplify specific sequences of gene M of A/H1N1, A/H3N2, A/H5N1, A/H7N7 and A/H9N2 viruses and of gene NP of type B viruses belonging both Yamagata and Victoria lineage. Specificity, analytical and clinical sensitivity, dynamic range, linearity of the new assays were evaluated. RESULTS: Dynamic ranges for Influenza A and B, and RSV were at least five logs and linearity was conserved. In order to evaluate the specificity, 80 nasopharyngeal swabs resulting Influenza and RSV negative by multiplex nested PCR and cell culture, were tested and 79 resulted negative. The detection limits for influenza A and B, calculated by 95% probit, was 0.008 and 0.09 PFU, respectively, resulting more sensible than nested PCR. A total of 75 specimens (10 A/H1N1, 3 A/H1N2, 8 A/H3N2 Johannesburg/94-like, 10 A/H3N2 Panama/2007/99-like, 10 A/H3N2 Fuijian/411/02-like, 2 A/H5N1, 2 A/H7N7 and 2 A/H9N2, 15 B/Yamagata-like and 13 B/Victoria-like) collected between 1994 and 2004 or received by WHO Influenza Centre, London, were chosen as representative of the circulating strains and tested. All samples resulted positive although one B/Victoria sample was not clear typed. Thirty swabs nested RT-PCR positive for RSV collected during the four seasons, were also analysed by realtime PCR, resulting positive. To evaluate the performance of the new assay on fresh material, 250 specimens, collected during the 2004/05 seasons, were tested by nested-PCR, cell culture and real-time PCR. DISCUSSION AND CONCLUSION: The new assays provide accurate and sensitive diagnosis of influenza and RSV infection and they represent a sensitive tool for virological surveillance and management of patient with ILI.

Effectiveness of a 23-valent polysaccharide vaccine in preventing pneumonia and non-invasive pneumococcal infection in elderly people: a large-scale retrospective cohort study.

This retrospective cohort study evaluated the effectiveness of a 23-valent pneumococcal polysaccharide vaccine in reducing hospital admission for pneumonia, otitis media and exacerbation of asthma or other syndromes due to Streptococcus pneumoniae in 9170 high-risk individuals. Cohort members were followed from 1 January 1998 to 31 December 2002. With regard to preventing hospitalization due to pneumonia, we observed a decrease in the incidence of 1/10000 person-months and a reduction in the relative risk of 38% in the vaccinated cohort compared with the non-vaccinated subjects. A decrease in the risk of hospital admission for asthma, acute otitis media, chronic obstructive pulmonary disease and other respiratory infections was also observed in vaccinated compared with non-vaccinated subjects. The specificity of these findings was confirmed by the lack of a protective effect from vaccination for those outcomes, such as hospitalization 'for all causes' and 'other otorhinolaryngological diagnoses', that were not directly related to pneumococcal disease.

Safety and immunogenicity of conventional subunit and MF59-adjuvanted influenza vaccines in human immunodeficiency virus-1-seropositive patients.

In this study of influenza vaccination, 37 human immunodeficiency virus (HIV)-1-seropositive patients were randomized to receive either a vaccine with a conventional subunit or one adjuvanted with MF59. Blood samples were collected at the time of vaccination, and then 30 and 180 days later, to evaluate immunogenicity, CD4+ T-lymphocyte count and HIV-1 RNA levels. Seroconversion rates against the three viral strains included in the vaccine ranged between 44% and 72% and 53% and 68% for the adjuvanted vaccine and the subunit vaccine, respectively. Other criteria of the European Medicines Evaluation Agency were also met. Vaccination was not associated with serious adverse events. Local and systemic effects were mild and of short duration. CD4+ T-lymphocyte counts and viraemia levels were not negatively affected by vaccination. These results confirmed the safety and immunogenicity of these currently available vaccines in HIV-1-seropositive patients, thus supporting the recommendation for influenza immunization in this high-risk category.