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Filia A.,Infectious Diseases Epidemiology Unit | Bella A.,Infectious Diseases Epidemiology Unit | von Hunolstein C.,National Center for Research and Evaluation of Immunobiologicals | Pinto A.,National Center for Research and Evaluation of Immunobiologicals | And 3 more authors.
Vaccine | Year: 2014

Despite being a completely preventable disease, tetanus cases continue to occur in Italy and notification and hospitalization rates have been reported to be higher with respect to European and other industrialized countries. We examined statutory notification, hospitalization, mortality and seroprevalence data to describe tetanus epidemiology in Italy from 2001 to 2010. A total of 594 tetanus cases were notified, with an average annual incidence of 1.0/1,000,000 population. Most cases were unvaccinated or incompletely vaccinated. Eighty percent of cases occurred in subjects aged >64 years and a higher proportion of females with respect to males were reported in this age group. The annual number of hospital admissions was 1.4-1.7 times greater than the number of notifications in the same year. The mean annual number of reported deaths was 21. Seroprevalence data show progressively higher susceptibility levels with increasing age. Over 50% of persons aged 45-64 years and over two thirds of subjects ≥65 years had tetanus antibody levels <0.01. IU/ml. Results show that tetanus is a continuing problem in Italy and, as in other countries, most cases occur in older adults, especially elderly women. The observed differences in notification and hospitalization rates suggest underreporting by physicians. In recent years, Italy has accounted for most cases reported annually in the European Union (EU) but different case definitions are used. In Italy, a confirmed case is one that meets the clinical case definition while the EU case definition classifies confirmed cases as those with laboratory confirmation of disease. The incidence of clinical tetanus in Italy is ten-fold higher than in other industrialized countries, like Australia and Canada, likely due to higher susceptibility levels in Italy. In view of the low prevalence of tetanus antibodies in adults ≥45 years, strategies to improve vaccine uptake in this population group need to be implemented. © 2013 Elsevier Ltd. Source

Delogu R.,National Center for Research and Evaluation of Immunobiologicals | Ianiro G.,Istituto Superiore di Sanita | Camilloni B.,University of Perugia | Fiore L.,National Center for Research and Evaluation of Immunobiologicals | Ruggeri F.M.,Istituto Superiore di Sanita
Journal of Medical Virology | Year: 2015

Rotavirus gastroenteritis is associated mainly with the five genotypes G1,3,4,9P[8] and G2P[4] that are common worldwide, but emerging strains including G6, G8, and G12 are also reported sporadically. G12P[8] rotavirus was observed unexpectedly to spread in a limited area of Italy during the rotavirus surveillance season 2012-2013. All strains were genotyped for VP7 and VP4 and subjected to phylogenetic analysis. Amino acid sequences of antigenic regions were compared with vaccine and field strains. G12P[8] strains were detected in the stools of 52 of 69 (75%) children infected with rotavirus in the central Italian region of Umbria. All G12 strains belonged to lineage III, and presented the P[8] genotype. Sequence analysis showed close nucleotide identity of both VP4 and VP7 genes among Umbria G12P[8] strains. The VP7 gene was also similar to other G12 strains circulating in different years and countries, and the VP4 gene was closely related to other local and global P[8] strains possessing different G-types. Overall findings suggest either the introduction and evolution of a G12 VP7 gene into the local Wa-like rotavirus population or the spreading of a strain novel for the area. Comparison of the VP8* and VP7 antigenic regions showed high conservation between the amino acid sequences of Umbria G12P[8] strains, and revealed various substitutions in the VP8* antigenic regions between the Italian G12P[8] strains and RotaTeq™ and Rotarix™ vaccine strains. The sudden and unexpected emergence of G12P[8] rotavirus confirms that these strains have the potential to become a sixth common genotype across the world. © 2015 Wiley Periodicals, Inc.. Source

Murtas S.,National Center for Research and Evaluation of Immunobiologicals | Gaggioli A.,National Center for Research and Evaluation of Immunobiologicals | von Hunolstein C.,National Center for Research and Evaluation of Immunobiologicals
Accreditation and Quality Assurance | Year: 2012

The measurement uncertainty in quantifying polysaccharides in glycoconjugate vaccines was estimated in order to ascertain compliance of these products in the batch release procedure of an Official Medicines Control Laboratory. A single-laboratory validation approach of an internal analytical procedure to quantify the total saccharide by the way of the sialic acid (N-Acetylneuraminic acid) concentration in a meningococcal glycoconjugate vaccine by High Performance Anion Exchange Chromatography coupled with Pulsed Amperometric Detection is reported. Uncertainty components from precision, bias and other sources were evaluated. It turned out that uncertainty is dominated by the precision contribution, while bias was mainly due to the non-recovery from hydrolysis. As a consequence, a correction factor was considered. At a confidence level of approximately 95%, the expanded uncertainty of the total polysaccharide concentration in a vaccine, when measured using the internal method, was found to be 11. 5%. © 2012 Springer-Verlag. Source

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