Neisseria meningitidis group B (MenB) is a leading cause of meningitis and sepsis. A new vaccine has been recently licensed. The aim of the present study was to evaluate the epidemiology of MenB disease in pediatric age and define the optimal age for vaccination. All patients aged 0-18 years admitted with a diagnosis of meningitis or sepsis to the 83 participating Italian pediatric hospitals were included in the study. Blood and/or cerebrospinal fluid (CSF) samples were tested by Realtime-PCR and/or culture. One hundred and thirty-six cases (mean age 5.0 years, median 2.7) of MenB disease were found. Among these, 96/136 (70.6%) were between 0 and 5 years, 61/136 (44.9%) were between 0 and 2 years. Among the latter, 39/61 (63.9%) occurred during the first year of life with highest incidence between 4 and 8 months. A case-fatality rate of 13.2% was found, with 27.8% cases below 12 months. Sepsis lethality was 24.4%. RT-PCR was significantly more sensitive than culture: 82 patients were tested at the same time by both methods, either in blood or in CSF; MenB was found by RT-PCR in blood or CSF in 81/82 cases (98.8%), culture identified 27/82 (32.9%) infections (Cohen's Kappa 0.3; McNemar's: p<10⁻⁵). The study shows that the highest incidence of disease occurs in the first year of age, with a peak between 4 and 8 months of life; 30% of deaths occur before 12 months. The results suggest that the greatest prevention could be obtained starting MenB vaccination in the first months of life; a catch-up strategy up to the fifth year of life could be considered. Our results also confirm that Realtime PCR is significantly more sensitive than culture. In those countries where only isolate positive infections are counted as cases, the incidence of MenB infection results highly underestimated.
Background: A few years after the introduction in Italy of a four-component anti-meningococcal B vaccine (4CMenB), we evaluated the effectiveness and impact of vaccination in two regions using different schedules (2, 4, 6, 12 months in Tuscany vs. 7, 9, 15 months in Veneto) through an observational retrospective study. Methods: Vaccination started in 2014 in Tuscany and in 2015 in Veneto; the data collected referred to the period 2006–2018 for Tuscany and 2007–2018 for Veneto. Cases of invasive meningococcal disease due to N. Meningitidis B were identified by culture and/or real-time PCR. Results: In Tuscany, pre-vaccine incidence was 1.96 (95% CL 1.52; 2.40) and dropped to 0.62 (95% CL 0.60; 0.64) in the post-4CMenB era. Evaluating only vaccinated children, post-4CMenB incidence was 0.12 (95% CL 0.08; 0.15). In Veneto pre-vaccine incidence was 1.94 (95% CL 1.92; 1.96) and dropped to 1.34 (95% CL 1.31; 1.38) in the post-4CMenB era. In the vaccinated population, MenB incidence was 0.53 (95% CL 0.50; 0.56). Vaccine effectiveness was 93.6% (95% CL 55.4; 99.1) in Tuscany and 91.0% (95% CL 59.9; 97.9) in Veneto, with mean vaccine coverages of 83.9% and 81.7%, respectively. The overall impact (evaluating both vaccinated and unvaccinated children) was 0.68 (95% CL 0.10; 0.89) in Tuscany and 0.31 (95% CL −0.56; 0.69) in Veneto; the total impact (evaluating only vaccinated children) was 0.94 (95% CL 0.56; 0.99) and 0.90 (95% CL 0.57; 0.97), respectively. The relative case reduction (RCR) was 65% in Tuscany and 31% in Veneto. Considering the vaccinated population, the RCR was equal to 91% and 80%, respectively. Conclusion: In conclusion, 4CMenB appears to have a very high effectiveness in Italy; the impact of vaccination appears greater where the immunization program is started early.
Underestimation is attributable to misdiagnosis, especially in fatal cases, and use of insufficiently sensitive laboratory methods.
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