This study evaluated the safety, tolerability, and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine, MenACWY-CRM, when administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis (Tdap) vaccine, in subjects aged 11 to 25 years. Subjects received either MenACWY-CRM and Tdap, MenACWY-CRM and saline placebo, or Tdap and saline placebo. No significant increase in reactogenicity and no clinically significant vaccine-related adverse events (AEs) occurred when MenACWY-CRM and Tdap were administered concomitantly. Similar immunogenic responses to diphtheria, tetanus, and meningococcal (serogroups A, C, W-135, and Y) antigens were observed, regardless of concomitant vaccine administration. Antipertussis antibody responses were comparable between vaccine groups for filamentous hemagglutinin and were slightly lower, although not clinically significantly, for pertussis toxoid and pertactin when the two vaccines were administered concomitantly. These results indicate that the investigational MenACWY-CRM vaccine is well tolerated and immunogenic and that it can be coadministered with Tdap to adolescents and young adults.
A serosurvey for measles, mumps and rubella was conducted in Italy; incidence based on statutory notifications over the last three decades was also calculated. In Italy the diseases followed an endemic-epidemic pattern, with an incidence peak every 2-4 years, and had a limited reduction of incidence attributable to childhood immunization. Lower notification rates were observed in the Southern regions. This is possibly related to greater under notification in the South and is confirmed by our seroprevalence data. Incidence of measles and rubella and proportion of cases among young adults increased significantly in the three decades considered, but not for mumps. Serological data confirmed that these infections are still very frequent in Italy, without significant geographic variation in the country. In the age groups 2-4 and 5-9 years the percentage of individuals still susceptible to each virus was higher than 30%. The proportion of susceptible subjects older than 15 years was similar for the three infections (6.1, 11.7 and 8.8% for measles, mumps and rubella, respectively). The low vaccine coverage for rubella and measles in Italy has so far only partially affected the occurrence of the diseases. No impact of mumps vaccination is visible. The average number of deaths, for each disease, has decreased during the three study periods. Today the priority in Italy is to halt the progressive increase of the mean age of acquisition of the three infections, to eliminate differences in coverage among regions and to conform to European standards. This will be achieved through a combination of increasing MMR vaccine coverage before 2 years of age, implementing vaccination campaigns for low seroprevalence age groups, and/or introducing a second dose of MMR, depending on the level of current MMR coverage.
Objective To assess the effectiveness of the current cervical cancer screening tools in Western Kazakhstan. Methods Smears taken through (i) conventional cytology using azur-eosin staining and (ii) liquid-based cytology (LBC) ‘Cell Scan’ in the general female population and in women first diagnosed with cervical cancer were collected throughout the region. ROC-analysis with curve construction and weighted Cohen's κ calculation were applied. A total of 494 cytological pairs were collected, including 94 sets with histology findings. Results The conventional (azur-eosin staining) technique contained 0.2% non-informative material and LBC ‘Cell Scan’ had 5.9%. Area under the curve was 0.95 for the conventional technique and 0.92 for ‘Cell Scan’ ( p > 0.05). The conventional smears showed κ 0.62, sensitivity 90.4% at specificity 90.0% for CIN2+, while LBC ‘Cell Scan’ smears showed κ 0.47, sensitivity 83.3% at specificity 92.5%. Conclusions In this analysis it was not possible to prove that the LBC ‘Cell Scan’ technique was superior to its predecessor, azur-eosin staining. These findings highlight the need to modify the current screening programme according to updated international scientific evidence on effective screening design, such as the use of HPV DNA testing with Pap smear triage in women aged 30 or older. Further research, and a Health Technology Assessment, are necessary if we wish to establish a national standardized screening programme using the available technology appropriately.
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