Meningococcal serogroup B vaccine in Italy: state-of-art, organizational aspects and perspectives.

Neisseria meningitidis causes severe invasive meningococcal diseases (IMDs) in humans including meningitis and septicemia, responsible for serious clinical conditions and leading to life-long disabilities and death. Serogroup B dominates IMDs burden in Italy, accounting for over 60% of total cases. On January 2013 the European Medicine Agency (EMA) licensed the first serogroup B meningococcal (MenB) vaccine in Europe. A number of European countries and Regions have introduced the new MenB vaccine in their immunization schedule, including Italy. In this paper we present the state of art, related critical issues and future perspectives of MenB vaccine introduction in Italy, in the context of the most recent available epidemiological data. In particular, we systematically assess the ongoing processes in the 8 Italian regions and one autonomous province that have already introduced MenB vaccine. With the new 2014-2018 National Vaccine Prevention Plan including active MenB vaccine offer about to be adopted, it is of fundamental importance to gather further evidence on MenB vaccine clinical effectiveness, duration of protection and cost-effectiveness. Italian regions are called to organize and manage MenB immunization programs. Careful consideration will need to be devoted on timing, doses, and co-administration with other vaccines but also to economic assessments and strengthened communication to the general public. Our data will help to plan, implement and evaluate MenB immunization programmes in other Italian and international settings.

Parents' and adolescents' willingness to be vaccinated against serogroup B meningococcal disease during a mass vaccination in Saguenay-Lac-St-Jean (Quebec).

A mass vaccination campaign with the 4CMenB vaccine (Bexsero®; Novartis Pharmaceutical Canada Inc) was launched in a serogroup B endemic area in Quebec. A telephone survey was conducted to assess parental and adolescent opinions about the acceptability of the vaccine. Intent to receive the vaccine or vaccine receipt was reported by the majority of parents (93%) and adolescents (75%). Meningitis was perceived as being a dangerous disease by the majority of parents and adolescents. The majority of respondents also considered the 4CMenB vaccine to be safe and effective. The main reason for positive vaccination intention or behaviour was self-protection, while a negative attitude toward vaccination in general was the main reason mentioned by parents who did not intend to have their child vaccinated. Adolescents mainly reported lack of interest, time or information, and low perceived susceptibility and disease severity as the main reasons for not intending to be vaccinated or not being vaccinated.

Une campagne de vaccination de masse avec le vaccin 4CMenB (Bexsero®; Novartis Pharma Canada Inc.) a été lancée dans une région du Québec endémique au sérogroupe B. Un sondage téléphonique afin d'évaluer l'acceptabilité du vaccin par les parents et les adolescents a été réalisé. La majorité des parents (93 %) et des adolescents (75 %) ont déclaré avoir l'intention de se faire vacciner / de faire vacciner leur enfant ou l'avoir déjà fait. La majorité des parents et des adolescents percevaient la méningite comme dangereuse et considéraient le vaccin 4CMenB comme sécuritaire et efficace. La protection de l'enfant était la principale raison d'accepter le vaccin chez les parents, tandis qu'une attitude négative envers la vaccination en général était la principale raison que donnaient les parents qui n'avaient pas l'intention de faire vacciner leur enfant. Les adolescents déclaraient surtout un manque d'intérêt, de temps ou d'information, la perception d'être peu susceptibles à la maladie et la perception que la maladie n'était pas très grave comme principales raisons de ne pas s'être fait vacciner ou de ne pas avoir l'intention de le faire.

A comprehensive review of clinical and real-world safety data for the four-component serogroup B meningococcal vaccine (4CMenB).

INTRODUCTION: Neisseria meningitidis causes invasive meningococcal disease and, globally, significant morbidity, with serogroup B (MenB) being the most common cause of endemic disease and outbreaks in several regions. Extensive use of the four-component serogroup B meningococcal vaccine (4CMenB; Bexsero, GSK) and its inclusion in immunization programs in several countries have generated substantial safety data during the 9 years since its first authorization in 2013. AREAS COVERED: 4CMenB safety data from clinical trials and post-marketing surveillance studies (2011 to 2022), and spontaneously reported adverse events of medical interest from the GSK global safety database. We discuss these safety findings in relation to the benefit of 4CMenB vaccination and implications for further enhancing vaccine confidence. EXPERT OPINION: 4CMenB has been consistently well tolerated across clinical trials and post-licensure surveillance studies, despite a higher incidence of fever reported in infants than with other pediatric vaccines. Surveillance data have not identified any significant safety issues, consistent with an acceptable safety profile of 4CMenB. These findings highlight the need to balance the risk of relatively common, transient, post-immunization fever with the benefit of affording protection that reduces the risk of uncommon but potentially fatal meningococcal infection.

The four-component serogroup B meningococcal vaccine 4CMenB (Bexsero®, GSK) was licensed in 2013 and has acquired substantial safety evidence through clinical trial and real-world data. Availability of real-world and clinical 4CMenB safety evidence is important to help address vaccination hesitancy. This comprehensive review of safety data, from 9 years of 4CMenB use including recent data from the real world, shows no significant safety issues in a variety of age groups. Data show that transient fever may occur after vaccination. Invasive meningococcal disease, although rare, can be life-threatening. Abundant safety data from this review can help reassure individuals and healthcare providers on the use of 4CMenB.

Broad vaccine protection against Neisseria meningitidis using factor H binding protein.

Neisseria meningitidis, the causative agent of invasive meningococcal disease (IMD), is classified into different serogroups defined by their polysaccharide capsules. Meningococcal serogroups A, B, C, W, and Y are responsible for most IMD cases, with serogroup B (MenB) causing a substantial percentage of IMD cases in many regions. Vaccines using capsular polysaccharides conjugated to carrier proteins have been successfully developed for serogroups A, C, W, and Y. However, because the MenB capsular polysaccharide is poorly immunogenic, MenB vaccine development has focused on alternative antigens. The 2 currently available MenB vaccines (MenB-4C and MenB-FHbp) both include factor H binding protein (FHbp), a surface-exposed protein harboured by nearly all meningococcal isolates that is important for survival of the bacteria in human blood. MenB-4C contains a nonlipidated FHbp from subfamily B in addition to other antigens, including Neisserial Heparin Binding Antigen, Neisserial adhesin A, and outer membrane vesicles, whereas MenB-FHbp contains a lipidated FHbp from each subfamily (A and B). FHbp is highly immunogenic and a main target of bactericidal activity of antibodies elicited by both licensed MenB vaccines. FHbp is also an important vaccine component, in contrast to some other meningococcal antigens that may have limited cross-protection across strains, as FHbp-specific antibodies can provide broad cross-protection within each subfamily. Limited cross-protection between subfamilies necessitates the inclusion of FHbp variants from both subfamilies to achieve broad FHbp-based vaccine coverage. Additionally, immune responses to the lipidated form of FHbp have a superior cross-reactive profile to those elicited by the nonlipidated form. Taken together, the inclusion of lipidated FHbp variants from both FHbp subfamilies is expected to provide broad protection against the diverse disease-causing meningococcal strains expressing a wide range of FHbp sequence variants. This review describes the development of vaccines for MenB disease prevention, with a focus on the FHbp antigen.

Do HCWs adequately know about meningitis and 4CMenB vaccine and recommend its use to parents? A cross sectional analysis in Campania Region, Italy.

Invasive meningococcal disease (IMD) is a severe disease caused by various Neisseria meningitidis serogroups that represents a serious public health problem worldwide. In Italy, serogroups B and C are the major causes of IMD. On 14 January 2013, the European Medicines Agency authorized the use of the first vaccine available to protect against meningococcal serogroup B (4CMenB). The aim of this study was to assess the IMD epidemiology knowledge and 4CMenB vaccine attitudes of healthcare workers (HCWs) with regard to recommending this vaccine for use, vaccine practices and infectious disease control in the Campania region in Italy. A cross-sectional study was conducted among 293 HCWs (49.5% physicians and 46.4% nurses)interviewed using a self-administered questionnaire. The majority of the HCWs had sufficient knowledge about the disease incidence and lethality, but they were less informed about the higher risk age categories and the serogroups most frequently involved. Additionally, their knowledge about the vaccine was poor with regard to the targeted categories and side effects. Approximately30.0% of the HCWs reported incidences of fever and pain and swelling at the injection site. Moreover,32.8% of the HCWs knew that the risk of developing adverse reactions increases when the 4CMenB vaccine is co-administered with other vaccines. Overall, all of the HCWs were convinced that vaccinations are an important instrument for preventing infectious diseases, and they were aware of their central role in promoting the 4CmenB vaccination and their need to be better informed.