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Updated incidence data of acute Delta virus hepatitis (HDV) are lacking worldwide. Our aim was to evaluate incidence of and risk factors for acute HDV in Italy after the introduction of the compulsory vaccination against hepatitis B virus (HBV) in 1991. Data were obtained from the National Surveillance System of acute viral hepatitis (SEIEVA). Independent predictors of HDV were assessed by logistic‐regression analysis. The incidence of acute HDV per 1‐million population declined from 3.2 cases in 1987 to 0.04 in 2019, parallel to that of acute HBV per 100,000 from 10.0 to 0.39 cases during the same period. The median age of cases increased from 27 years in the decade 1991–1999 to 44 years in the decade 2010–2019 (p <.001). Over the same period, the male/female ratio decreased from 3.8 to 2.1, the proportion of coinfections increased from 55% to 75% (p =.003) and that of HBsAg positive acute hepatitis tested for by IgM anti‐HDV linearly decreased from 50.1% to 34.1% (p <.001). People born abroad accounted for 24.6% of cases in 2004–2010 and 32.1% in 2011–2019. In the period 2010–2019, risky sexual behaviour (O.R. 4.2; 95%CI: 1.4–12.8) was the sole independent predictor of acute HDV; conversely intravenous drug use was no longer associated (O.R. 1.25; 95%CI: 0.15–10.22) with this. In conclusion, HBV vaccination was an effective measure to control acute HDV. Intravenous drug use is no longer an efficient mode of HDV spread. Testing for IgM‐anti HDV is a grey area requiring alert. Acute HDV in foreigners should be monitored in the years to come. [ABSTRACT FROM AUTHOR]

Background: Influenza A(H3N2), A(H1N1)pdm09 and B viruses co‐circulated in Europe in 2017‐18, predominated by influenza B. WHO‐recommended, trivalent vaccine components were lineage‐mismatched for B. The I‐MOVE hospital network measured 2017‐18 seasonal influenza vaccine effectiveness (IVE) against influenza A(H3N2) and B among hospitalised patients (≥65 years) in Europe. Methods: Following the same generic protocol for test‐negative design, hospital teams in nine countries swabbed patients ≥65 years with recent onset (≤7 days) severe acute respiratory infection (SARI), collecting information on demographics, vaccination status and underlying conditions. Cases were RT‐PCR positive for influenza A(H3N2) or B; controls: negative for any influenza. "Vaccinated" patients had SARI onset >14 days after vaccination. We measured pooled IVE against influenza, adjusted for study site, age, sex, onset date and chronic conditions. Results: We included 3483 patients: 376 influenza A(H3N2) and 928 B cases, and 2028 controls. Most (>99%) vaccinated patients received the B lineage‐mismatched trivalent vaccine. IVE against influenza A(H3N2) was 24% (95% CI: 2 to 40); 35% (95% CI: 6 to 55) in 65‐ to 79‐year‐olds and 14% (95% CI: −22 to 39) in ≥80‐year‐olds. Against influenza B, IVE was 30% (95% CI: 16 to 41); 37% (95% CI: 19 to 51) in 65‐ to 79‐year‐olds and 19% (95% CI: −7 to 38) in ≥80‐year‐olds. Conclusions: IVE against influenza B was similar to A(H3N2) in hospitalised older adults, despite trivalent vaccine and circulating B lineage mismatch, suggesting some cross‐protection. IVE was lower in those ≥80 than 65‐79 years. We reinforce the importance of influenza vaccination in older adults as, even with a poorly matched vaccine, it still protects one in three to four of this population from severe influenza. [ABSTRACT FROM AUTHOR]

Background: Evidence on influenza vaccine effectiveness (VE) in preventing mortality and morbidity in the elderly is weak. Our aim was to measure the VE against severe outcomes in the elderly. Methods: We conducted a multicentre hospital-based test-negative design (TND) case-control study, during the 2017/18 season, in four Italian hospitals. The study population included individuals aged ≥65 years hospitalized with Severe Acute Respiratory Infections (SARI). Patients were classified as cases and controls based on the results of the PCR influenza testing. We estimated VE by virus subtypes and specific VE for the trivalent adjuvanted vaccine (TIVadj). Results: 502 patients with SARI were enrolled: 118 (23.5%) tested positive (cases) and 384 (76.5%) tested negative (controls) for influenza. The adjusted VE of 48.5% for all vaccines was comparable to the adjusted VE for the TIVadj vaccine (48.3%). Adjusted VE for the TIVadj vaccine was 67.5% for A(H1N1)pdm09 and 44.5% for B viruses. Conclusion: We show a moderate adjusted VE of the TIVadj against all viruses, a good adjusted VE against A(H1N1)pdm09 strains and a moderate adjusted VE against B strains, despite a mismatch between the B circulating lineage and the lineage included in the vaccine. This is likely due to the cross-protection among B strains induced by the TIVadj in elderly patients. [ABSTRACT FROM AUTHOR]

Background. Hepatitis B vaccination has proven to be very safe and highly effective. This study assessed the proportion of successfully vaccinated individuals among cases with acute hepatitis B, the proportion of preventable cases if individuals were vaccinated as recommended, and the reasons for failures. Methods. We analyzed data reported to the Italian Surveillance System for Acute Viral Hepatitis from 1993 to 2014. Results. A total of 362 of 11 311 (3.2%) cases with acute hepatitis B were vaccinated. Of the 277 cases for whom immunization data were available, 50 (18%) received a complete vaccination course according to the correct schedule and before exposure to hepatitis B virus. Molecular characterization of 17 of these cases showed that 6 were infected with S-gene mutants. Among the 10 949 unvaccinated cases, 213 (1.9%) escaped mandatory vaccination and 2821 (25.8%) were not vaccinated despite being at increased risk of infection. Among the latter, the most common risk factors were cohabitation with hepatitis B surface antigen (HBsAg) carriers, intravenous drug use, and homosexual/bisexual practices. Thirty-seven percent of the unvaccinated households with HBsAg carriers were aware of their risk. Lack of trust in the vaccination, negative attitude, and inaccurate beliefs followed by lack of or poor communication and low perceived severity of the disease were the most frequent reasons for vaccine hesitancy. Conclusions. Development of acute disease in successfully vaccinated individuals is a rare event. Further efforts are needed to enhance the vaccine coverage rate in individuals at increased risk of infection. [ABSTRACT FROM AUTHOR]

Background: Foodborne Hepatitis A Virus (HAV) outbreaks are being recognized as an emerging public health problem in industrialized countries. In 2013 three foodborne HAV outbreaks occurred in Europe and one in USA. During the largest of the three European outbreaks, most cases occurred in Italy (>1,200 cases as of March 31, 2014). A national Task Force was established at the beginning of the outbreak by the Ministry of Health. Mixed frozen berries were early demonstrated to be the source of infection by the identity of viral sequences in patients and in food. In the present study the molecular characterization of HAV isolates from 355 Italian cases is reported. Methods: Molecular characterization was carried out by PCR/sequencing (VP1/2A region), comparison with reference strains and phylogenetic analysis. Results: A unique strain was responsible for most characterized cases (235/355, 66.1%). Molecular data had a key role in tracing this outbreak, allowing 110 out of the 235 outbreak cases (46.8%) to be recognized in absence of any other link. The data also showed background circulation of further unrelated strains, both autochthonous and travel related, whose sequence comparison highlighted minor outbreaks and small clusters, most of them unrecognized on the basis of epidemiological data. Phylogenetic analysis showed most isolates from travel related cases clustering with reference strains originating from the same geographical area of travel. Conclusions: In conclusion, the study documents, in a real outbreak context, the crucial role of molecular analysis in investigating an old but re-emerging pathogen. Improving the molecular knowledge of HAV strains, both autochthonous and circulating in countries from which potentially contaminated foods are imported, will become increasingly important to control outbreaks by supporting trace back activities, aiming to identify the geographical source(s) of contaminated food, as well as public health interventions. [ABSTRACT FROM AUTHOR]

Background: The aims of this study were: a) to evaluate attitudes and practices of health care workers (HCWs) towards influenza vaccination and their opinion regarding a vaccination promotion toolkit; b) to estimate hospital HCWs' influenza vaccination coverage rates (VC). Methods: The Bambino Gesù Children's Hospital (OPBG) is an academic hospital in Italy. Since 2009, free influenza vaccination is offered to HCWs during working hours. In October-December 2013, a communication campaign based on a standardized toolkit was conducted. In December 2013, we performed a cross-sectional survey in a sample of hospital wards, based on a self-administered questionnaire including participants' characteristics; self-reported influenza vaccination history; reasons for vaccination or missed vaccination; opinion regarding the toolkit. Multivariable logistic analysis was used to assess independent predictors of influenza vaccination status. Annual VC for years 2009-2013 was estimated by using the number of seasonal influenza vaccine doses administered to HCWs as numerator, and the number of hospital HCWs as denominator. Results: Out of 191 HCWs who participated in the survey, 35.6 % reported at least one influenza vaccination during their life; 6.8 % adhered to annual revaccination. Years of service and professional category were significantly and independently associated with vaccination (adjusted-OR: 2.4 for > 10 years of service, compared to < 5 years of service; adjusted-OR: 2.6 for physicians compared to nurses). Patient protection was the main reported reason for vaccination (34.3 %); considering influenza a mild disease was the main reason for non-vaccination (36.9 %); poor vaccine effectiveness was the main reason for missed annual revaccination (28.8 %). Overall, 75 % of respondents saw at least one promotion tool; 65.6 % of them found the information useful. Hospital VC decreased from 30 % in 2009, to 5 % in 2012. In 2013, VC was 14 %. Conclusions: Satisfactory influenza VC in HCWs is hard to achieve. In 2013, along with the toolkit implementation, we observed an increase in HCWs' vaccination coverage, nevertheless, it remained unsatisfactory. Tailored information strategies targeting nurses and recently employed HCWs should be implemented. Institution of declination statements, adding influenza vaccination to financial incentive systems, or vaccination requirements should also be considered to increase influenza VC among HCWs. [ABSTRACT FROM AUTHOR]

Background: The aims of this study were: a) to evaluate attitudes and practices of health care workers (HCWs) towards influenza vaccination and their opinion regarding a vaccination promotion toolkit; b) to estimate hospital HCWs’ influenza vaccination coverage rates (VC). Methods: The Bambino Gesù Children’s Hospital (OPBG) is an academic hospital in Italy. Since 2009, free influenza vaccination is offered to HCWs during working hours. In October-December 2013, a communication campaign based on a standardized toolkit was conducted. In December 2013, we performed a cross-sectional survey in a sample of hospital wards, based on a self-administered questionnaire including participants’ characteristics; self-reported influenza vaccination history; reasons for vaccination or missed vaccination; opinion regarding the toolkit. Multivariable logistic analysis was used to assess independent predictors of influenza vaccination status. Annual VC for years 2009–2013 was estimated by using the number of seasonal influenza vaccine doses administered to HCWs as numerator, and the number of hospital HCWs as denominator. Results: Out of 191 HCWs who participated in the survey, 35.6 % reported at least one influenza vaccination during their life; 6.8 % adhered to annual revaccination. Years of service and professional category were significantly and independently associated with vaccination (adjusted-OR: 2.4 for > 10 years of service, compared to < 5 years of service; adjusted-OR: 2.6 for physicians compared to nurses). Patient protection was the main reported reason for vaccination (34.3 %); considering influenza a mild disease was the main reason for non-vaccination (36.9 %); poor vaccine effectiveness was the main reason for missed annual revaccination (28.8 %). Overall, 75 % of respondents saw at least one promotion tool; 65.6 % of them found the information useful. Hospital VC decreased from 30 % in 2009, to 5 % in 2012. In 2013, VC was 14 %. Conclusions: Satisfactory influenza VC in HCWs is hard to achieve. In 2013, along with the toolkit implementation, we observed an increase in HCWs’ vaccination coverage, nevertheless, it remained unsatisfactory. Tailored information strategies targeting nurses and recently employed HCWs should be implemented. Institution of declination statements, adding influenza vaccination to financial incentive systems, or vaccination requirements should also be considered to increase influenza VC among HCWs. [ABSTRACT FROM AUTHOR]

Background: Over the past 20 years, Hepatitis A notifications in Italy have been in decline. Since the beginning of 2013 however, Italy has been experiencing a foodborne hepatitis A outbreak caused by genotype IA, involving hundreds of cases. Consumption of frozen mixed berries was deemed the potential vehicle of infection. We aimed to investigate the spread of hepatitis A virus (HAV) in Italy through the monitoring of urban sewages collected at Wastewater Treatment Plants (WTPs) and a subsequent comparison of environmental surveillance data with data from the clinical surveillance performed during the epidemic. Methods: The study covered 15 months, from July 2012 to September 2013, comprising the outbreak and the preceding six months. Environmental surveillance consisted of the analysis of urban sewage samples collected at 19 WTPs in seven of the Italian regions most affected by the epidemic. HAV isolates were detected and typed using a nested RT-PCR targeting the VP1/2A junction. Parallel clinical surveillance was performed by the sentinel surveillance system for acute viral hepatitis (SEIEVA) and by the ministerial Central Task Force on Hepatitis A, established with the purpose of determining the source of the outbreak and adopting appropriate outbreak control strategies. Results: A total of 38/157 wastewater samples (24.2%) were positive for HAV, 16 collected in 2012 and 22 in 2013. Several HAV strains were detected, including the IA variant implicated in the outbreak and isolated from clinical cases over the same period. The vast majority of sequences belonged to genotype IB. Interestingly however, although these included variants related to strains that had been involved in past Italian epidemics, none were detected in recent clinical samples, probably due to underreporting or asymptomatic circulation. Conversely, a number of sequences were identified in clinical samples that were not found in wastewaters. Conclusions: The percentage of sewage samples detected as HAV-positive in this study are consistent with the classification of Italy as a country with low/intermediate endemicity. A combined environmental/clinical surveillance is able to provide a more complete picture of the spread of HAV and of the genotypes circulating in the population, allowing a better understanding of changes in disease trends. [ABSTRACT FROM AUTHOR]

Every season, circulating influenza viruses change; therefore, vaccines must be reformulated each year. We aimed to estimate vaccine effectiveness (VE) against severe influenza infection for the 2018/19 season in Italy. We conducted a test-negative design case-control study at five Italian hospitals. We estimated influenza VE against severe acute respiratory infection (SARI) requiring hospitalisation overall, and by virus subtype, vaccine brand, and age. The 2018/19 season was characterised by A(H1N1)pmd09 and A(H3N2) influenza viruses. Vaccine coverage among <18 years recruited SARI cases was very low (3.2%). Seasonal vaccines were moderately effective against type A influenza overall (adjusted VE = 40.5%; 95% confidence interval (CI) = 18.7–56.4%) and subtype A(H1N1)pmd09 viruses (adjusted VE = 55%; 95% CI = 34.5–69.1%), but ineffective against subtype A(H3N2) viruses (adjusted VE = 2.5%; 95% CI = −50.0–36.7%). Both Fluad and Fluarix Tetra vaccines were effective against type A influenza overall and subtype A(H1N1)pdm09 viruses. VE appeared to be similar across age groups (0–64 years, ≥65 years). Seasonal influenza vaccines in the 2018/19 season were moderately effective in preventing SARI caused by A(H1N1)pdm09 influenza but ineffective against A(H3N2). [ABSTRACT FROM AUTHOR]

Background: Surveillance for adverse events following immunization is an important component of any national immunization programme because it is critical to assessing the safety of vaccines and to detecting potentially rare and severe adverse events and responding in a timely manner. We conducted an enhanced active surveillance aimed at assessing the safety of flu vaccines in the 2015-2016 season in Italy. The study was targeted to the population groups for which the seasonal vaccine is recommended in Italy.Methods: During the study period, a total of 3213 individuals receiving seasonal influenza vaccination were registered on the web-based platform. Any adverse events experienced after 7 days from vaccination by individuals aged six months or more were collected through a telephone interview or by a web-based self-administered questionnaire. All individuals experiencing at least one event during the 7 days of follow-up were contacted for follow-up to 60 days.Results: Overall, 854 events were reported: 845 events (26%) after administration of the first dose and 9 (12%) after the second dose. The majority of adverse events reported after 7 days from the first dose were of little clinical importance, and most involved local symptoms.Conclusion: Our data, even though the number of vaccinated individuals was smaller than expected, is consistent with the safety of influenza vaccines in Italy during the 2015-2016 season regarding the most common adverse events. Further efforts are needed to obtain sufficient power to study rarer adverse events. Active monitoring and systematic studies to test generated signals and hypotheses are crucial to intensify awareness among the public and professionals with regard to the safety of vaccines. [ABSTRACT FROM AUTHOR]