Acute Delta Hepatitis in Italy spanning three decades (1991–2019): Evidence for the effectiveness of the hepatitis B vaccination campaign

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

Case–control study on intestinal intussusception: implications for anti-rotavirus vaccination

Background: Intussusception represents the most common cause of abdominal emergency among young children but nearly 75% of cases are still considered idiopathic. Research design and methods: A case–control study was conducted among Sicilian children aged 0–59 months with a hospital admission for intussusception between 2009 and 2015 to identify factors associated with intussusception onset. Results: Overall, 125 cases and 190 controls were recruited for the study. Birth order (OR 1.49, 95%CI: 1.10, 2.02, P = 0.02) and having had gastroenteritis or having taken antibiotics during the 30 days prior to hospitalization (OR 11.55, 95%CI: 3.23, 41.23, P < 0.001; 3.09, 95%CI: 1.17, 8.12, P = 0.009, respectively) were significantly associated with intussusception. On the other hand, exclusive breastfeeding for at least two months was a protective factor (OR 0.48, 95%CI: 0.23, 0.99, P = 0.009). Anti-rotavirus vaccination did not correlate with risk of intussusception (OR 0.96, 95% CI: 0.41, 2.25, P = 0.92). Conclusions: These findings increase the awareness of intussusception among clinical and public health service providers to obtain a better susceptibility profile. Moreover, identifying children at higher risk of intussusception could be useful in vaccination counselling to intercept early symptoms and to reduce the number of serious cases

Measles and Pregnancy: Immunity and Immunization—What Can Be Learned from Observing Complications during an Epidemic Year

Measles is a highly contagious airborne disease. Unvaccinated pregnant women are not only at risk of infection but also at risk of severe pregnancy complications. As measles causes a dysregulation of the entire immune system, we describe immunological variations and how immune response mechanisms can lead to adverse pregnancy outcomes. We evaluated data during the measles outbreak reported in the province of Catania, Italy, from May 2017 to June 2018. We controlled hospital discharge records for patients admitted to hospital obstetric wards searching the measles diagnostic code. We have indicated the case as “confirmed” when the IgM was found to be positive with the ELISA method. We registered 843 cases of measles and 51% were females (430 cases). 24 patients between the ages of 17 and 40 had measles while they were pregnant. Adverse pregnancy outcomes included 2 spontaneous abortions, 1 therapeutic abortion, 1 foetal death, and 6 preterm deliveries. Respiratory complications were more prevalent in pregnant women (21%) than in nonpregnant women with measles (9%). 14 health care workers (1.7%) were infected with measles, and none of these had been previously vaccinated. Immune response mechanisms were associated with adverse pregnancy outcomes in women with measles. To reduce the rate of measles complications, gynaecologists should investigate vaccination history and antibody test results in all women of childbearing age. During a measles outbreak, gynaecologists and midwives should be active proponents of vaccination administration and counteract any vaccine hesitancy not only in patients but also among health care workers

Booster vaccination of pre-school children with reduced-antigen-content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine co-administered with measles-mumps-rubella-varicella vaccine: a randomized, controlled trial in children primed according to a 2 + 1 schedule in infancy

Pertussis occurs in older children, adolescents and adults due to waning immunity after primary vaccination. Booster vaccination for pre-school children has been recommended in Italy since 1999. In this study (NCT00871000), the immunogenicity, safety and reactogenicity of a booster dose of reduced-antigen content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (dTpa-IPV; GSK Biologicals Boostrix\u2122-Polio; 3-component pertussis) vs. full-strength DTPa-IPV vaccine (sanofi-pasteur--MSD Tetravac\u2122; 2-component pertussis) was evaluated in pre-school Italian children

The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy

Introduction Multiple vaccination visits and administrations can be stressful for infants, parents and healthcare providers. Multivalent combination vaccines can deliver the required number of antigens in fewer injections and clinic visits, while vaccine co-administration can also reduce the number of visits. This non-inferiority study was undertaken to evaluate the feasibility of co-administering a combined measles-mumps-rubella-varicella (MMRV) vaccine with conjugated meningococcal C (MenC) vaccine in a large cohort of healthy Italian toddlers. Methods Healthy subjects aged 13–15 months were randomized (2:1:1) to receive single doses of either: co-administered MMRV + MenC at the same visit (MMRV + MenC group); or MMRV followed 42 days later by MenC (MMRV group); or MenC followed 42 days later by MMRV (MenC group). Blood samples were collected before and 43 days after vaccination. Antibody titers against MMRV were measured using ELISA. Functional-anti-meningococcal-serogroup activity (rSBAMenC) was assessed using a serum bactericidal test. Solicited local and general reactions were recorded for up to 4 and 42 days post-vaccination, respectively. Non-inferiority of MMRV + MenC to MMRV (post-dose-1 seroconversion rates) and MMRV + MenC to MenC (post-dose-1 seroprotection rates) was achieved if the lower limit (LL) of the 95% confidence interval (CI) for the group difference was ⩾−10% for each antigen. Results 716 subjects were enrolled in the study. At 42 days post-vaccination, the MMRV seroconversion rates were 99.3% (measles), 94.5% (mumps), 100% (rubella) and 99.7% (varicella) in the MMRV + MenC group, and 99.4%, 93.2%, 100% and 100%, respectively, in the MMRV group. The seroprotection rates against rSBA-MenC were 98.3% in the MMRV + MenC group and 99.3% in the MenC group. Non-inferiority was reached for all the vaccine antigens. The safety profiles were as expected for these vaccines. Conclusion The immune responses elicited by co-administered MMRV + MenC were non-inferior to those elicited by MMRV or MenC alone and support vaccination of children with both vaccines at a single visit. Clinical Trials registration: NCT01506193

Real life hexavalent vaccination among children as a practical guide for public health professionals: Four years (from 2016 to 2019) of clinical practice in Sicily, Italy

Hexavalent (HV) vaccination is a priority for newborn protection and in Italy is included in the National Immunization Plan with a three doses cycle at 61, 121 and 301 days of age. A retrospective clinical study has been conducted to evaluate real life clinical practice of HV vaccination in the fourth most populous Italian Region. Data on the completion of the HV cycle, on the interchangeability between the two HV adopted in 2016–2017 (DTaP3-IPV-HB/Hib) and 2018–2019 (DTaP5-IPV-HB-Hib) and on the use above the established age, were collected in five Sicilian Local Health Authorities. Data showed an average 91.5% completion of the vaccination cycle at 24 months of age. The average age of administration was significantly higher in children who switched between the two hexavalent vaccines compared to those who completed the vaccination cycle with the same product (p-value 36 months) significantly after the introduction of mandatory vaccination in Italy (p-value <.001). This retrospective analysis will contribute to manage potential disruptions due to missed routine immunization opportunities, as the pandemic has caused, with strategies such as catch up above recommended age as well as interchangeability. Data could also help to demonstrate the need to optimize vaccine sessions through co-administration, that strongly contribute to increase vaccination coverage rates and respect of timing of vaccination schedules

Molecular Epidemiological and Antibiotic Susceptibility Characterization of Brucella Isolates from Humans in Sicily, Italy▿

Brucellosis is a serious problem in Sicily. Brucella melitensis was identified as the species most frequently isolated in humans in Italy. No data, however, are available about the molecular epidemiological characterization of Brucella isolates from humans. We have conducted this study to molecularly characterize clinical isolates of Brucella spp. and to evaluate their antimicrobial susceptibilities. Twenty Brucella isolates were studied. Differential growth characteristics and DNA polymorphisms such as the restriction patterns of the PCR-amplified omp2a and omp2b genes, rpoB nucleotide sequencing, and multiple-locus variable-number tandem repeat analysis of 16 loci (MLVA-16) were used to characterize the strains. In vitro antibiotic susceptibility was determined by the E-test method on two different agar media, and the results were compared. All isolates were identified as B. melitensis biovar 3. rpoB nucleotide sequence analysis allowed the identification of two different genotypes of B. melitensis biovar 3. On the other hand, the MLVA-16 typing assay recognized 17 distinct genotypes. All isolates were sensitive to all tested antibiotics (rifampin, doxycycline, ciprofloxacin, ceftriaxone, and trimethoprim-sulfamethoxazole), and the Mueller-Hinton agar plate is recommended for antibiotic susceptibility testing by the E-test method. Our findings identify B. melitensis biovar 3 as the etiological agent isolated in Sicily and encourage the use of both molecular methods, and in particular of the MLVA-16 assay, in epidemiological trace-back analysis. This study represents the first epidemiological data from molecular typing of Brucella strains circulating in Italy and, in particular, in eastern Sicily