[Quadrivalent conjugate vaccines against ACWY meningococcal disease]. / I vaccini coniugati quadrivalenti contro i meningococchi ACWY.

Invasive meningococcal disease (IMD) is caused by 6 serogroups of the bacterium Neisseria meningitidis (A, B, C, W, X and Y). It is among the most serious vaccine preventable infectious diseases, characterized by a high case-fatality rate and risk of permanent sequelae. Worldwide, the incidence of IMD is generally low with differences among regions and age groups. The risk increases in overcrowded conditions or in case of travel to endemic areas. The first vaccines produced using polysaccharide capsular antigens have demonstrated a good protective efficacy, but of short lenght. The conjugation of antigens with proteins allowed to obtain a longlasting antibody response towards 4 serogroups: A, C, W, Y. Currently four ACWY quadrivalent conjugate vaccines are available, three of them approved in Europe, which have shown high immunogenicity and safety. In 2020 the MenACYW-TT vaccine conjugated to tetanus toxoid was approved in the USA and it is presently authorized in Europe for the immunization of individuals from 12 months of age. Clinical studies have demonstrated immunogenicity and safety on population samples belonging to different age groups and non-inferiority in comparing it with other vaccines already in use. The possibility of having an increasing number of safe, immunogenic and effective vaccines against IMD allows us to imagine a future without invasive meningococcal disease. It is therefore important to extend vaccination to an increasing number of subjects of different age groups and risk conditions.

Invasive meningococcal disease in Italy: from analysis of national data to an evidence-based vaccination strategy.

INTRODUCTION: Invasive meningococcal disease (IMD) is one of the most severe vaccine-preventable disease not yet under control. In Italy, although different anti-meningococcal vaccines are available, their offer among regions is heterogeneous. The aim of this study is to describe the epidemiology of IMD in Italy based on analysis of national surveillance data for 2011-2017 to optimize the vaccination strategy. METHODS: IMD surveillance data from the Italian National Health Institute were analysed. Microsoft Excel was used to present trend analysis, stratifying by age and serogroups. RESULTS: In Italy, during the period 2011-2017, the incidence of IMD increased from 0.25 cases/100,000 inhabitants in 2011 to 0.33 cases/100,000 in 2017. Most cases after 2012 were caused by non-B serogroups. The number of cases in subjects aged 25-64 years increased steadily after 2012 (36 cases in 2011, 79 in 2017), mostly due to non-B serogroups, representing more than 65% of cases in those aged 25+ years. CONCLUSIONS: In the period from 2011 to 2017, the incidence of IMDs increased in Italy. The increase, probably due also to a better surveillance, highlights the importance of the disease in the adult population and the high level of circulation of non-B serogroups in particular after 2012. Our analysis supports an anti-meningococcal vaccination plan in Italy that should include the highest number of preventable serogroups and be aimed at vaccinating a wider population through a multicohort strategy.

HPV self-sampling in CIN2+ detection: sensitivity and specificity of different RLU cut-off of HC2 in specimens from 786 women.

AIMS: Mortality for cervical cancer varies between the different regions of the world, with high rates in low-income countries where screening programmes are not present and organised. However, increasing screening coverage is still a priority in all countries: one way to do that is to base screening on self-sampled screening. The success of a self-sampling screening strategy depends on capacity to recruit unscreened women, on the performance and acceptability of the device and on the clinical performance of the high-risk human papillomavirus (HPV) test. METHODS: This study based on 786 enrolled women investigates the best cut-off value of Hybrid Capture 2 HPV test (HC2) for self-sampled specimens in terms of sensitivity and specificity. RESULTS: In this population, we found that the sensitivity and the specificity for cervical intraepithelial neoplasia grade 2 or more detection of HC2 performed on self-sampled specimens were 82.5% and 82.8%, respectively considering the relative light units (RLU) cut-off value of 1. Increasing the cut-off value the sensitivity decreases and the specificity raises and the best area under the curve for the RLU cut-off value is 1. CONCLUSIONS: Our results confirm that the cut-off value of 1 suggested by Qiagen for PreservCyt specimen is the best cut-off value also for self-sampled specimens.

Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions.

Analytical and clinical performance validation is essential before introduction of a new human papillomavirus (HPV) assay into clinical practice. This study compares the new BD Onclarity HPV assay, which detects E6/E7 DNA from 14 high-risk HPV types, to the Hybrid Capture II (HC2) HPV DNA test, to concurrent cytology and histology results, in order to evaluate its performance in detecting high-grade cervical lesions. A population of 567 women, including 325 with ≥ASCUS (where ASCUS stands for atypical cells of undetermined significance) and any HC2 result and 242 with both negative cytology and negative HC2 results, were prospectively enrolled for the study. The overall agreement between Onclarity and HC2 was 94.6% (95% confidence intervals [CI], 92.3% to 96.2%). In this population with a high prevalence of disease, the relative sensitivities (versus adjudicated cervical intraepithelial neoplasia grades 2 and 3 [CIN2+] histology endpoints) of the Onclarity and HC2 tests were 95.2% (95% CI, 90.7% to 97.5%) and 96.9% (95% CI, 92.9% to 98.7%), respectively, and the relative specificities were 50.3% (95% CI, 43.2% to 57.4%) for BD and 40.8% (95% CI, 33.9%, 48.1%) for HC2. These results indicate that the BD Onclarity HPV assay has sensitivity comparable to that of the HC2 assay, with a trend to an increased specificity. Moreover, as Onclarity gives the chance to discriminate between the different genotypes, we calculated the genotype prevalence and the absolute risk of CIN2+: HPV 16 was the most prevalent genotype (19.8%) with an absolute risk of CIN2+ of 77.1%.