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Background: Tuberculosis (TB) is a social disease that is common in immigrants who are forced to live in difficult circumstances. In Italy, the guidelines for preventing TB include X-ray screening and application of the Mantoux test for migrants from high–TB-endemic countries as soon as possible after admission to Italy. This article describes a field survey conducted in the reception center for asylum seekers in Bari Palese in southern Italy following the death of a center resident from pulmonary TB. Methods: A Mantoux screening test, followed by chest X-ray, was carried out in March 2009 on 982 immigrants, representing 97.5% of the residents of the center. Results: A positive Mantoux test result was seen in 60.7% of the residents screened. The chest X-rays were performed on 92.9% of cuti-positive patients and on cuti-negative patients who were recent contacts of the deceased TB case and/or with symptoms suspicious for TB. Eight residents were diagnosed with active TB (0.8% of residents), and 117 residents (11.9%) had TB sequelae. In our survey, the Mantoux test demonstrated 88% sensitivity, 17% specificity, and a positive predictive value of 1% for active TB. Conclusion: The survey results suggest that residents in asylum centers are a special type of immigrant. Specific risk factors, such as overcrowding, may expose these residents to a greater risk for infectious diseases. [Copyright &y& Elsevier]

The aim of the study is to assess the determining factors and the level of vaccination coverage for those vaccinations recommended to health care workers. The employees of the Apulian Vaccination Services were given an interview-based standardized anonymous questionnaire. Of the 302 replies from the employees, 54.5% of the respondents had received the hepatitis B vaccine and 32.7% the influenza vaccine in the 2007-2008 season. There were 4.6% susceptible to varicella, and 2.6% had been vaccinated. Of the replies received, 9.3% were susceptible to measles or mumps or rubella, and 5.9% had been vaccinated. There is the need for on-going education for vaccine requirements to improve immunoprophylaxis among health care workers. [Copyright &y& Elsevier]

Background: Streptococcus pneumoniae, lancet-shaped, gram-positive, facultative anaerobic organisms, are common inhabitants of the respiratory tract and may be isolated from the nasopharynx of 5% to 70% of healthy adults. Objective: The aims of the study were to estimate the vaccination coverage for pneumococcal 23-valent polysaccharide vaccine and to assess the impact its introduction in the Italian region of Puglia, where a program to provide this vaccination has been operative since 2000. Methods: Estimation of the coverage for pneumococcal 23-valent polysaccharide vaccine was implemented by a 2-step study consisting of data collection from local health unit vaccination registers between 2000 and 2008 in Puglia and of a cluster sampling study among general practitioners to validate routine data collected during the first step. Moreover, hospitalization for invasive pneumococcal diseases was studied. Results: From 2000 to 2004, among individuals ≥65 years, the overall coverage rate estimated by routine data amounted to 26.3%; between 2005 and 2007, annual coverage rates did not exceed 8%/year. Between 2002 and 2007, the overall coverage rate estimated by interviewing general practitioners was 46.6% (95% confidence interval: 39.9-53.4). The coverage rate in chronic patients by routine data was approximately 23%, whereas the rate provided by general practitioners was 17.6% (95% confidence interval: 12.5-22.8). From 2001 to 2007, hospitalization data did not show a reduction in invasive pneumococcal disease trends among the elderly population in Puglia. Conclusion: The results of this study demonstrate the need for improving vaccine coverage and implementing new immunization strategies and practices. [Copyright &y& Elsevier]

SARS-CoV-2 vaccination can bring an important benefit for older people in terms of reduction of mortality and hospitalization; however, reports of rare adverse effects like altered consciousness and delirium among this demographic have raised concerns. This study aimed to assess delirium incidence post-SARS-CoV-2 vaccination and its predictors in older residents across 60 Italian long-term care facilities (LTCFs). This is a prospective cohort study considering data from GeroCovid Vax, a multicenter cohort study jointly performed by the Italian Society of Gerontology and Geriatrics (SIGG) (Florence, Italy) and the Italian National Institute of Health (Istituto Superiore di Sanità—ISS, Rome, Italy), and sponsored by the Italian Medicines Agency (Agenzia Italiana del Farmaco—AIFA). GeroCovid Vax enrolled LTCFs residents aged ≥60 who received at least 1 anti–SARS-CoV-2 vaccine dose. Baseline data covered sociodemographic details, chronic diseases, medications, nutritional status, cognitive and functional assessments, mobility, and frailty. Delirium was assessed post-first, second, and booster vaccine doses using DSM-5 criteria. Data analysis involved descriptive statistics, multivariate logistic regression, and network analysis. A total of 2521 participants (mean age 83.10 ± 9.21 years, 70.7% female) were analyzed. Delirium incidence post-first, second, and booster doses was 3.5%, 1.6%, and 1.5%, respectively. Age, preexisting cognitive disorders, and frailty were significant predictors of delirium, with odds ratios (ORs) of 1.70 (95% CI, 1.08–2.77), 2.05 (95% CI, 1.40–2.97), and 1.77 (95% CI, 1.25–2.52), respectively. Prior use of antipsychotics (OR, 1.75; 95% CI, 1.22–2.51) and antidepressants (OR, 1.77; 95% CI, 1.25–2.52) correlated significantly with delirium. Network analysis indicated a strong association between anorexia and delirium. Post-vaccination delirium is infrequent and decreases with subsequent doses. Timely assessments for frailty and cognitive impairment could aid in stratifying delirium risk among LTCF residents, facilitating enhanced prevention measures and close monitoring for delirium indicators. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the relationship between morphologic and functional abnormalities in patients affected with adult-onset foveomacular vitelliform macular dystrophy (AFVD). Design: Prospective, noncomparative observational study. Methods: A complete ophthalmologic examination, including best-corrected visual acuity (BCVA), fundus examination, fundus-related perimetry, and optical coherence tomography (OCT), was performed in 20 consecutive AFVD patients. The stage of the disease and the thickness of the neuroepithelium at the foveola (neurosensory retina) were compared with the BCVA as well as with the type of scotoma, the average retinal sensitivity, and the location and stability of fixation. Results: Thirty-five eyes of 20 consecutive patients (10 men and 10 women; mean age, 58.2 years) were graded as follows: 10 had vitelliform stage (stage 1), nine had pseudohypopyon stage (stage 2), 10 had vitelliruptive (stage 3), and six had atrophic stage (stage 4) disease. Reduced thickness of the neuroepithelium at the foveola and BCVA were statistically correlated to an advanced stage of the disease (P = .001 and P = .0062, respectively). Moreover, worse BCVA was correlated statistically to reduced thickness of the neuroepithelium at the foveola (r = 0.14; P = .02). Reduced thickness of the neuroepithelium at the foveola was correlated statistically to the development of absolute scotoma (P = .03), eccentric fixation (P = .01), and unstable fixation (P = .03). Conclusions: OCT and fundus-related perimetry allow a correlation to be defined between foveal thickness and visual function and are useful tools to define better the degree of anatomic and functional impairment in AFVD patients. [Copyright &y& Elsevier]

• We conducted a survey on vaccine shortages and stockouts in Europe in 2016–2019. • Vaccine shortages and stockouts were reported by 19 of 21 surveyed countries. • The vaccines most frequently affected were DT-containing and hepatitis B vaccines. • The most commonly reported causes were production issues and global shortage. • Vaccine shortages/stockouts had a relevant impact on vaccine services. National immunisation programmes require an adequate supply of vaccines to function properly but many countries, globally and in Europe, have reported vaccine shortages. A comprehensive view of vaccine shortages and stockouts in the EU/EEA is missing in the published literature. This study was conducted in the framework of the European Joint Action on Vaccination (EU-JAV). Twenty-eight countries, including 20 EU-JAV consortium member states and an additional 8 EU/EEA countries, were invited to participate in a survey aimed at collecting information on vaccine shortages and stock-outs experienced from 2016 to 2019, their main causes, actions taken, and other aspects of vaccine supply. Twenty-one countries completed the survey (response rate 75%), of which 19 reported at least one shortage/stock-out event. Overall, 115 events were reported, 28 of which led to a change in the national immunisation programme. The most frequently involved vaccines were DT- and dT-containing combination vaccines, hepatitis B, hepatitis A, and BCG vaccines. The median duration of shortages/stock-outs was five months (range <1 month–39 months). Interruption in supply and global shortage were the most frequently indicated causes. Only about half of countries reported having an immunization supply chain improvement plan. Similarly, only about half of countries had recommendations or procedures in place to address shortages/stockouts. The survey also identified the occurrence of shortages/stockouts of other biological products (e.g. diphtheria antitoxin in 12 countries). Public health strategies to assure a stable and adequate vaccine supply for immunization programmes require coordinated actions from all stakeholders, harmonized definitions, strengthening of reporting and monitoring systems, the presence of an immunization supply chain improvement plan in all countries, and procedures or recommendations in place regarding the use of alternative vaccines or vaccination schedules in case of shortages/stockouts. [ABSTRACT FROM AUTHOR]

• 42.4% preterms in Italy receive delayed hexavalent vaccine due to parents' concerns. • Parents of preterms vaccinated with Hexyon reported systemic adverse effects as rarer. • We aimed at filling hexavalents safety knowledge gaps in pediatric clinical practice. Recommendations in many countries state that preterm infants (PTIs) should receive the same routine immunization schedule and timing as for full-term births, according to their chronological age. Data regarding hexavalent vaccine safety in PTIs are still limited. We conducted a post-marketing surveillance study of the DTaP2-IPV-HB-Hib vaccine administered to PTIs in Apulia region, Italy. We identified PTIs by selecting the hospital discharge records of infants born between January and June 2017 using the DRG and ICD-9-CM codes for preterm birth, and we matched these data with records included in the regional immunization registry. We analyzed coverage and timeliness of vaccination. To investigate adverse events (AEs) after the first dose, we interviewed via phone the parents of PTIs vaccinated with at least one dose of the DTaP2-IPV-HB-Hib vaccine. At the time of our analysis (31.12.2017), 866/936 (92.5%) PTIs received the first dose of hexavalent vaccine and 539/936 (57.6%) were vaccinated by the third month of age, as recommended; 700/866 (80.8%) received the DTaP2-IPV-HB-Hib vaccine. The parents of 339 PTIs vaccinated with the DTaP2-IPV-HB-Hib vaccine reported local pain as the most common reaction (35.7% of the children). Erythema, swelling, induration and nodule were also reported in about 25% of the children. Systemic adverse events were generally rarer than local reactions. No serious AEs were reported. Our findings showed that more than 40% of PTIs received delayed hexavalent vaccination. This study showed a reassuring safety profile of the vaccine in the preterm population and may be considered as a pilot for further real-world studies. [ABSTRACT FROM AUTHOR]

Since 2013, World Health Organization (WHO) recommended that adverse events following immunization (AEFIs) should be evaluated by a standardized algorithm for causality assessment, however the use of WHO procedure is rarely adopted. In Italy, AEFIs (classified only by temporal criteria) are registered in the National Drug Authority (AIFA) database, but causality assessment is not mandatory. Every year AIFA publishes the AEFIs report, that doesn’t contain information about causal correlation between events and vaccines. From AIFA database, we selected AEFIs following human papillomavirus vaccination (HPV) reported in Apulia (about 4,000,000 inhabitants) during 2008–2016. For serious AEFIs, we applied WHO causality assessment criteria; for cases hospitalized, we repeated the assessment getting additional information from health documentation. In 2008–2016, 100 HPV AEFIs (reporting rate: 17.8 per 100,000 doses) were registered of which 19 were serious (rate: 3.4 per 100,000 doses) and 12 led to hospitalization. After causality assessment, for 9 AEFIs the classification was “consistent causal association to immunization”, for 3 indeterminate, for 5 “inconsistent causal association to immunization” and for 2 not-classifiable. Among hospitalized patients, 5 AEFIs were consistent, 5 inconsistent, 1 not-classifiable and 1 indeterminate; adding information from health documentation, the results were similar except for indeterminate and not classifiable AEFIs that turned into “not consistent”. Only half of severe AEFIs could be associated with vaccination and this suggests that AIFA report provides a incomplete picture of HPV vaccine safety, with a risk for readers to confound “post hoc” and “propter hoc” approach without considering the causality assessment results. In the view of the systematic use of WHO causality assessment algorithm in the AEFI surveillance, the efforts of Public Health must be focused on the improvement of the quality of the information provided to reduce conclusions inter-observer variability; the routine follow-up of reports, also to collect additional information, must be guaranteed. [ABSTRACT FROM AUTHOR]

In Italy, in 2016, we conducted a cross-sectional survey to estimate vaccine hesitancy and investigate its determinants among parents of children aged 16–36 months. Data on parental attitudes and beliefs about vaccinations were collected through a questionnaire administered online or self-administered at pediatricians’ offices and nurseries. Parents were classified as pro-vaccine, vaccine-hesitant or anti-vaccine, according to self-reported tetanus and measles vaccination status of their child. Multivariable logistic regression was used to investigate factors associated with hesitancy. A total of 3130 questionnaires were analysed: 83.7% of parents were pro-vaccine, 15.6% vaccine-hesitant and 0.7% anti-vaccine. Safety concerns are the main reported reason for refusing (38.1%) or interrupting (42.4%) vaccination. Anti-vaccine and hesitant parents are significantly more afraid than pro-vaccine parents of short-term (85.7 and 79.7% vs 60.4%) and long-term (95.2 and 72.3% vs 43.7%) vaccine adverse reactions. Most pro-vaccine and hesitant parents agree about the benefits of vaccinations. Family pediatricians are considered a reliable source of information by most pro-vaccine and hesitant parents (96.9 and 83.3% respectively), against 45% of anti-vaccine parents. The main factors associated with hesitancy were found to be: not having received from a paediatrician a recommendation to fully vaccinate their child [adjusted odds ratio (AOR): 3.21, 95% CI: 2.14–4.79], having received discordant opinions on vaccinations (AOR: 1.64, 95% CI: 1.11–2.43), having met parents of children who experienced serious adverse reactions (AOR: 1.49, 95% CI: 1.03–2.15), and mainly using non-traditional medical treatments (AOR: 2.05, 95% CI: 1.31–3.19). Vaccine safety is perceived as a concern by all parents, although more so by hesitant and anti-vaccine parents. Similarly to pro-vaccine parents, hesitant parents consider vaccination an important prevention tool and trust their family pediatricians, suggesting that they could benefit from appropriate communication interventions. Training health professionals and providing homogenous information about vaccinations, in line with national recommendations, are crucial for responding to their concerns. [ABSTRACT FROM AUTHOR]

In Italy, Hib conjugate vaccine was introduced for infants in 1999 and included in the DTaP-HBV-IPV-Hib combination in 2001, with an uptake of 83.4% in 2002, >90% by 2005, and >95% by 2011. We estimated the impact of Hib vaccination on hospitalizations for H. influenzae invasive disease in children <5 years. Age-specific hospitalization rates and hospitalization risk ratios (HRRs) with 95%CI during 2001–2013 were calculated performing time-series analysis. The number of cases reported to the national surveillance of invasive bacterial diseases was compared to the number of hospitalizations between 2007–2013. Hospitalization rates declined from 2.3 in 2001 to 0.9 × 100,000 in 2002 (HRR = 0.4, 95%CI = 0.3–0.6, p < 0.05) among children 1–4 years and from 5.4 in 2001 to 2.4 × 100,000 in 2005 (HRR = 0.4, 95%CI = 0.2–0.9, p < 0.05) among infants. During 2007–2013: 401 cases were reported, 242 were typed, 12.4% were by serotype b; 861 hospital admissions were recorded. Applying the percentage of typed b strains retrieved from the surveillance to the number of hospitalizations for invasive H. influenzae disease, an estimated 107 episodes could be attributable to serotype b. These findings provided reassuring data on the impact of Hib vaccination on the burden of hospitalization for invasive disease in Italian children. [ABSTRACT FROM AUTHOR]

Although concerns about safety of influenza vaccination during pregnancy have been raised in the past, vaccination of pregnant women was recommended in many countries during the 2009 A/H1N1 pandemic influenza. A retrospective cohort study was conducted to evaluate the risk of adverse maternal, fetal and neonatal outcomes among pregnant women vaccinated with a MF59-adjuvanted A/H1N1 pandemic influenza vaccine. The study was carried out in four Italian regions (Piemonte, Friuli-Venezia-Giulia, Lazio, and Puglia) among 102,077 pregnant women potentially exposed during the second or third trimester of gestation to the vaccination campaign implemented in 2009/2010. Based on data retrieved from the regional administrative databases, the statistical analysis was performed using the Cox proportional-hazards model, adjusting for the propensity score to account for the potential confounding effect due to the socio-demographic characteristics and the clinical and reproductive history of women. A total of 100,332 pregnant women were eligible for the analysis. Of these, 2003 (2.0%) received the A/H1N1 pandemic influenza vaccination during the second or third trimester of gestation. We did not observe any statistically significant association between the A/H1N1 pandemic influenza vaccination and different maternal outcomes (hospital admissions for influenza, pneumonia, hypertension, eclampsia, diabetes, thyroid disease, and anaemia), fetal outcomes (fetal death after the 22nd gestational week) and neonatal outcomes (pre-term birth, low birth weight, low 5-min Apgar score, and congenital malformations). Pre-existing health-risk conditions (hospital admissions and drug prescriptions for specific diseases before the onset of pregnancy) were observed more frequently among vaccinated women, thus suggesting that concomitant chronic conditions increased vaccination uptake. The results of this study add some evidence on the safety of A/H1N1 pandemic influenza vaccination during pregnancy but, because of the reduced statistical power, meta-analyses and large multi-centres studies are needed in order to obtain more conclusive results, especially for rare outcomes. [ABSTRACT FROM AUTHOR]

Abstract: Temporal trends of Hepatitis A cases and vaccination coverage data against Hepatitis A Virus have been investigated to analyse the impact of the universal routine vaccination strategy more than 10 years from its introduction in Puglia (region of Southern Italy). The basic reproductive number (R 0) before vaccination introduction and the effective reproductive number (R e) after introduction have been calculated. A progressive decrease in incidence has been recorded in Puglia during last 10 years. Vaccination coverage is actually 64.8% (95% CI: 52.7–76.9%) for children aged 12–24 months and of 67.6% (95% CI: 58.4–76.8%) for 12-year-old adolescents. R 0 estimated in 1996 was 2.01; actually R e is 0.651. Theoretical age at infection is 31.82 years. Universal routine vaccination aimed at the control of direct transmission remains the milestone in the strategy for the containment of the disease in settings at an intermediate level of endemicity. [ABSTRACT FROM AUTHOR]

Abstract: We describe an outbreak of varicella at a preschool center in Southern Italy, in the period January–May 2009, among children with a vaccination coverage of 53.9% for one dose. The outbreak occurred in a small community in Puglia and enrolled 41 children. The attack rates for unvaccinated and vaccinated children were 72.3% and 12.7%, respectively. The vaccine effectiveness against disease was 82.4%. Our findings add a further piece of evidence in supporting the routine use of a second dose of vaccine for all children without a history of disease, as recently recommended by the ACIP of the CDC. [Copyright &y& Elsevier]

Abstract: Our research group has recently been able to demonstrate and validate the possibility of studying of 3p microsatellite alterations (MAs) in the DNA extracted from the exhaled breath condensate (EBC) of healthy smokers and of subjects with non-small cell lung cancer (NSCLC). In light of the interest that has recently been aroused in the novel molecular staging protocol of lung cancer, the evaluation of the prognostic power of the genetic alterations involved in lung cancerogenesis, including 3p microsatellite alterations could be of clinical interest. Purpose: The aim of this study was to investigate the outcome predictive power of exhaled 3p microsatellite alterations in lung cancer patients. Patients and methods: Seventy-one NSCLC patients were enrolled in the study. All the subjects under study had already undergone a 3p microsatellite analysis of their EBC. A total of 56 patients were either given a follow-up of at least 102 weeks, or were followed up until death. Results: The number of 3p microsatellite alterations found in the exhaled breath condensate DNA exhibits a remarkable correlation with patients’ survival. D3S2338 and D3S1289 account for the microsatellites with the highest positive prognostic power; loss of heterozygosis (LOH) D3S1289 has a negative prognostic value in adenocarcinoma while microsatellite instability (MI) and LOH D3S2338 influence survival in squamous cell carcinoma; and, independently of NSCLC stage, D3S1289 is associated with poor prognosis. Conclusions: In conclusion, 3p MAs in the DNA of exhaled breath condensate is strongly associated with NSCLC patients’ survival. Our results suggest that it is possible to use the study of EBC MAs as an outcome predictor for lung cancer patients. [Copyright &y& Elsevier]