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Resume Objectifs En decembre 2013, le Haut Conseil de la sante publique a recommande l’utilisation de Bexsero ® (vaccin contre le meningocoque B) dans les zones en situation a risque specifique et pour les patients a risque d’infections invasives a meningocoque B. Dans ce contexte, InfoVac-France a mis en place une enquete nationale quelques mois apres l’autorisation de mise sur le marche (AMM) dans le but d’apprecier l’adhesion ou les reticences des medecins face a ce nouveau vaccin. Methodes Cette enquete a ete proposee par courrier electronique en avril 2014 aux medecins du reseau InfoVac-France. Un courriel initial expliquait le but de cette enquete et proposait de repondre a un questionnaire en ligne. Resultats Entre le 29 avril et le 16 mai 2014, 1502 medecins ont complete le formulaire d’enquete : 502 medecins generalistes (MG) (33 %), 939 pediatres (63 %) et 61 autres specialistes (4 %). Quatre-vingt-onze pour cent des medecins etaient favorables a l’introduction du vaccin dans le calendrier vaccinal francais et 87 % des pediatres et 50 % des MG savaient qu’il etait disponible et commercialise. L’information des medecins concernant ce vaccin avait ete faite le plus souvent via InfoVac (61 %). Les schemas de vaccination selon les âges etaient peu connus des medecins (9 % des generalistes contre 43 % des pediatres). En pratique, cette vaccination etait rarement proposee (18 %), le plus souvent a cause du non-remboursement (62 %). Si 39 % des medecins envisageaient de proposer ce vaccin a leur patientele, 54 % s’interrogeaient encore. Au total, 9 % des pediatres et 2 % des generalistes avaient deja pratique cette vaccination. Conclusion Cette enquete montre que les medecins interroges etaient favorables a l’introduction de ce vaccin mais que des interrogations persistaient concernant l’efficacite sur le terrain, la duree de protection et l’effet sur le portage.

Background and objectives: Vaccination against bacterial pathogens is decisive for preventing invasive meningococcal disease and pediatricians play a pivotal role in vaccination compliance and coverage. The aim of this study was to investigate awareness, attitude, and practices toward the vaccine against Meningococcal B serogroup (4CMenB) among a sample of Italian pediatricians. Materials and Methods: A cross-sectional study was carried out using an online questionnaire from March to May 2015. Three multivariate logistic regression models were built to identify factors associated with the outcomes of interest. Results: The data showed that 95.5% of the interviewees correctly responded about the availability of 4CMenB vaccine in Italy, while only 28.0% knew the vaccination schedule for children aged two years or under. This knowledge was significantly higher in younger pediatricians and in those who worked a higher number of hours per week. Pediatricians self-reported a positive attitude toward the utility and safety of 4CMenB vaccine. Those pediatricians with a strong positive attitude toward the utility of the vaccine, who knew the vaccination schedules for children of two years or under, and who declared a satisfactory or good knowledge about the vaccine were more likely to inform parents about its availability in Italy, recommend the vaccination, and verify patients’ vaccination status, in their daily practice. Conclusions: The study highlights factors that currently influence pediatricians’ practices regarding the 4CMenB vaccine. The results showed the possible actions recommended to improve physicians’ awareness and behaviors in order to improve the vaccination compliance and invasive meningococcal diseases prevention.

Neisseria meningitidis serogroup B (MenB) is the most common cause of bacterial meningitis in many industrialized countries and occurs at any age. The highest incidence is in infants aged1 year, followed by children and adolescents. Four-component MenB vaccine (4CMenB, Bexsero) is the only MenB vaccine authorized for use in all age-groups. Experience with 4CMenB is growing as it is implemented in different countries/age-groups encompassing university students, children, adolescents, and infant mass vaccination programs.An update of recently available data describing the mechanism of immunogenicity of 4CMenB and real-world evidence of vaccine effectiveness and disease impact. We discuss the appropriate age for vaccination to maximize population impacts.Invasive meningococcal disease is uncommon and sufficiently powered efficacy studies were not feasible during 4CMenB development. Additionally, several thousand genetically diverse invasive MenB strains circulate globally, varying widely in surface protein expression. This posed significant challenges in predicting clinical protection with MenB vaccines. Five years of 4CMenB use post-licensure confirm the clinical benefit of vaccination as predicted during development. Preliminary evidence suggests an extended impact on other meningococcal serogroups and Neisseria gonorrhoeae.

BACKGROUND: In 2015, ACIP recommended 16–23 year olds may be vaccinated with serogroup B meningococcal (MenB) vaccine based on individual clinical decision-making (Category B). OBJECTIVE: To assess among US pediatricians (Peds) and family physicians (FPs): 1) practices regarding MenB vaccine delivery; 2) factors influencing a decision to recommend vaccine; 3) factors associated with discussing MenB vaccine at 16–18 year-old routine visits. DESIGN/METHODS: We surveyed a nationally representative sample of Peds and FPs by e-mail and internet from 10–12/2016. RESULTS: The response rate was 72% (660/916). During routine visits, 51% of Peds and 31% of FPs reported always/often discussing MenB vaccine. Among those who discussed often/always, 91% recommended vaccination; among those who never/rarely discussed, 11% recommended. 73% of Peds and 41% of FPs currently administered MenB vaccine. While many providers reported not knowing about factors influencing recommendation decisions, serogroup B meningococcal disease outbreaks (89%), disease incidence (62%), and effectiveness (52%), safety (48%), and duration of protection of MenB vaccine (39%) increased likelihood of recommending while the Category B recommendation (45%) decreased likelihood. Those somewhat/not at all aware of MenB vaccine [Risk Ratio 0.32 (95% CI 0.25–0.41)] and those practicing in an HMO [0.39 (0.18–0.87)] were less likely whereas those aware of disease outbreaks in their state [1.25 (1.08–1.45)] were more likely to initiate a discussion about MenB vaccine. CONCLUSION(S): Primary care physicians have significant gaps in knowledge about serogroup B meningococcal disease and MenB vaccine and this appears to be a major driver of the decision not to discuss the vaccines.

Aim To document the clinical features and management of infants presenting with fever after their first meningococcal B vaccination and develop guidance for clinicians. Methods A prospective case series over 12 months was conducted in a tertiary paediatric hospital. Infants ≤3 months of age with fever who had received their first set of immunisations within the preceding 72 h were included. Results A total of 92 infants met the inclusion criteria, accounting for 0.78% of the local vaccinated population. The most commonly described associated features were poor feeding, sleepiness and irritability; 66 patients (72%) were admitted to hospital. Median C-reactive protein (CRP) was 12 mg/L, and median white cell count (WCC) was 16 × 109 /L. Fifteen patients (16%) had a lumbar puncture and were commenced on antibiotics. There was one confirmed bacterial infection in an infant who had presented with fever starting 54 h after immunisation. All other microbiology samples were negative. There were no cases of missed serious bacterial infection (SBI) in those patients who were observed or discharged. Conclusions The routine investigation of infants presenting with post-immunisation fever is not warranted if the infant appears otherwise well on examination. Where other common associated features are present or there is clinical concern, a period of observation is a prudent course of action. Paracetamol should be given peri-immunisation as per the national guidance. We suggest selective use of investigations, especially inflammatory markers, which are unlikely to discriminate between SBI and post-immunisation response. We advocate extra caution in infants presenting with fever more than 48 h after immunisation.

We sought to identify the characteristics of men who have sex with men (MSM) who are opinion leaders on immunization issues and to identify potential opportunities to leverage their influence for vaccine promotion within MSM communities. Using venue-based sampling, we recruited and enrolled MSM living in Los Angeles (N = 520) from December 2016 to February 2017 and evaluated characteristic differences in sociodemographic characteristics, health behaviors, and technology use among those classified as opinion leaders versus those who were not. We also asked respondents about their past receipt of meningococcal serogroups A, C, W, and Y (MenACWY) and meningococcal B (MenB) vaccines, as well as their opinions on the importance of 13 additional vaccines. Multivariable results revealed that non-Hispanic black (aOR = 2.64; 95% CI: 1.17–5.95) and other race/ethnicity (aOR = 2.98; 95% CI: 1.41–6.29) respondents, as well as those with a history of an STI other than HIV (aOR = 1.95; 95% CI: 1.10–3.48), were more likely to be opinion leaders. MenACWY (aOR = 1.92; 95% CI: 1.13–3.25) and MenB (aOR = 3.09; 95% CI: 1.77–5.41) vaccine uptake, and perceived importance for these and seven additional vaccines, were also associated with being an opinion leader. The results suggest that the co-promotion of vaccination and other health promotion initiatives via opinion leaders could be a useful strategy for increasing vaccination among MSM.

Objective To document the clinical features and management of infants presenting with fever after their first meningococcal B vaccination, and develop guidance for clinicians. Design A prospective case series over a 12 month period. Setting The Royal Hospital for Children Glasgow, a tertiary paediatric hospital. Patients Infants≤3 months of age who had received their first set of immunisations (including Bexsero) within the preceding 72 hours and reported fever. Results Ninety two infants met the inclusion criteria, accounting for 0.78% of the local vaccinated population. The most commonly described features were poor feeding, sleepiness and irritability. Sixty six patients (72%) were admitted to hospital. Median CRP was 12 mg/L and median WCC was 16 × 109/L.Fifteen patients (16%) had a lumbar puncture and were commenced on antibiotics. There was one confirmed bacterial infection in an infant who had presented with fever starting 54 hours after immunisation. All other microbiology samples were negative. There were no cases of missed serious bacterial infection (SBI) in those patients observed or discharged. Conclusion Post-immunisation fever is a common presenting problem to the paediatric emergency department. Based on our findings, routine investigations are not warranted if the infant appears well on examination. Where other common side effects are present and there is clinical concern, a period of observation may be a reasonable option. We suggest selective use of investigations, especially inflammatory markers, that are unlikely to discriminate between serious bacterial infection and post-immunisation response. We advocate extra caution in infants presenting with fever more than 48 hours after immunisation.

Background The UK on 01 September 2015 became the first country to introduce Meningococcal B (Bexsero) vaccine into the national infant immunisation programme. Bexsero is recommended for all infants as part of their routine vaccinations at ages 2, 4 and 12 months alongside other regular vaccines. Bexsero is highly immunogenic and is estimated to protect against 73%–88% of MenB strains causing invasive meningeal disease (IMD) in England and Wales1. Objective We retrospectively evaluated tolerability of Bexsero vaccine on preterm babies in our neonatal intensive care unit. Methods Retrospective observational study comparing tolerability of the vaccines in the two time periods, before (Period 1, n=13) and following (Period 2, n=13) the introduction of the new vaccine (Bexsero) in September 2015. We inspected the clinical status 48 hours prior to and 48 hours post immunisation to evaluate vaccine tolerance during these two time periods. Results Before introduction of Men B vaccine, there was convincingly low levels of side effects in our babies following routine immunisation. After introduction of MenB vaccine, 46% (6/13) of babies became unwell within 24–48 hours of immunisation; 30% (4/13) needed escalation in respiratory support. 15% (2/13) needed rescue ventilation after Bexsero vaccination. Conclusions We hypothesised that all babies immunised with Bexsero alongside regular vaccines will remain clinically stable and will tolerate the vaccines without any appreciable side effects. 46% of our babies became unwell following the combined MenB programme, raising speculations about safety profile of the Bexsero in preterm infants. Precautionary monitoring following vaccination is recommended. Larger studies are needed to ensure safety of Bexsero vaccine in preterm babies.

It is imperative to ensure biological products are free of contaminating pyrogenic material prior to administration to patients. Historically the rabbit pyrogen test (RPT) was used to screen for such contamination in medicines for intravenous delivery. This test was adapted for use to screen vaccines. However, some, including meningococcal vaccines containing outer membrane vesicles, are intrinsically pyrogenic. Indeed, this is the case for Bexsero which contains relatively high levels of endotoxin and other potential pyrogens such as lipoproteins and porins. The RPT proved a difficult method for measuring the pyrogenic content of Bexsero and differences between laboratories in different countries made repeat testing at the control laboratories problematic resulting in batches being wrongly identified as unsafe. At NIBSC a monocyte activation test (MAT) was adapted and validated as an alternative. This required setting of a specification in-house and deciding on a decisional procedure using multiple donors, allowing batches equally pyrogenic or less, than those batches shown to be safe in a clinical trial, to be certified as safe. The resulting format was a reference comparison method with an upper limit of 1.8 relative pyrogen units (RPU). The batch passed if an initial four donors had a response equal to or less than 1.8 RPU, if one donor is above this limit the batch was tested in a further four donors and seven of the eight must be equal to or below 1.8 RPU. If two donors have a response greater than 1.8 the batch failed.

The aim of this collaborative study was to evaluate the robustness of the monocyte activation test (MAT) for quantifying the pyrogenic content in the outer membrane vesicle (OMV)-containing vaccine Bexsero: the first meningococcal B vaccine to be licenced. We analysed datasets from 9 laboratories covering 15 test systems for 3 batches of Bexsero with higher, equivalent and lower activity relative to a reference lot in the MAT. Activity was measured in terms of relative pyrogen units (RPU) based on European Pharmacopoeia (Ph. Eur.) MAT Chapter 2.6.30 Method C: Reference Lot Comparison Test. We report that all 15 test systems were consistent in that they showed sample A to be the most active in the MAT; that 13 of 15 test systems had an accuracy of more than 80% and an overall geometric mean RPU of 1.03 with lower and upper 95% confidence limits of 0.97 and 1.09 respectively for a sample with an expected value of 1.00 RPU. We also report larger variability in the results for test systems involving cells from individual blood donations for sample A suggesting that there could be donor to donor differences in sensitivity to the vaccine constituents responsible for the higher activity of this batch. Overall, the consistency and accuracy of the MAT was remarkable given the range of test systems used by participants, all of which are permitted by the Ph. Eur. General MAT Chapter. This is important given the limitations of the rabbit pyrogen test for the control of pyrogenicity in general and particularly with products with intrinsic pyrogenicity such as Bexsero.

Introduction: Given the characteristics of meningococcal carriage and transmission and the sudden, often severe onset and long-term consequences of disease, vaccination can most effectively provide large-scale control of invasive disease. Six serogroups (A, B, C, W, X, and Y) cause nearly all meningococcal disease globally. Capsular polysaccharide conjugate vaccines can prevent serogroups A, C, W, and Y disease. More recently, recombinant protein vaccines for preventing serogroup B meningococcal (MenB) disease have become available, with a major target of vaccine-induced immune response for both vaccines being bacterial factor H binding protein (FHbp). Importantly, FHbp segregates into only two distinct subfamilies (A [also classified as variants 2 and 3] and B [variant 1]). This review summarizes the complete clinical development program supporting licensure of MenB-FHbp (Trumenba®, Bivalent rLP2086), the only MenB vaccine containing antigens from both FHbp subfamilies. Areas covered: Eleven published clinical studies assessing MenB-FHbp efficacy and safety among 20,803 adolescents and adults are examined. Particular focus is on the methodology of immunogenicity assessments used as a surrogate for clinical efficacy. Expert commentary: Clinical studies in adolescents and adults consistently demonstrated MenB-FHbp safety and induction of immunologic responses against antigenically and epidemiologically diverse MenB isolates, supporting licensure and immunization recommendations.

We were interested to read the report by So et al 1 describing an infant who was unwell prior to receiving their first set of primary immunisations (including the four-component meningococcal B vaccine 4CMenB; Bexsero; GSK Biologicals) and was subsequently diagnosed with meningococcal group W meningitis shortly after vaccination. The authors highlight factors that would not have been consistent with an adverse event following immunisation (AEFI), namely the onset of fever prior to immunisation and the presentation with focal seizures, which is rare following 4CMenB vaccination, even when administered concurrently with routine immunisations.2 Such a …

The United Kingdom is the first country to introduce Bexsero(®) (GSK Biologicals), a multicomponent, protein-based vaccine against meningococcal group B (MenB), into the national infant immunisation programme. This vaccine is like no other licensed vaccine and poses a number of implementation and surveillance challenges in England. From 01 September 2015, UK infants were offered a reduced two dose primary immunisation schedule at 2 and 4 months followed by a booster at 12 months. Because of high rates of fever post-vaccination, parents were advised to give their infants three doses of prophylactic paracetamol, with the first dose given as soon as possible after the primary MenB vaccination dose. Since the vaccine only protects against 73-88% of MenB strains causing invasive disease in England, clinical isolates and PCR-positive samples will require extensive characterisation by the Meningococcal Reference Unit (MRU) at Public Health England (PHE) in order to monitor vaccine effectiveness and identify potential vaccine failures. PHE is also conducting detailed clinical and epidemiological surveillance to assess the impact of the MenB immunisation programme on the morbidity and mortality associated with invasive meningococcal disease in infants and young children.

Aim The four-component meningococcal serogroup B (4CMenB) vaccine was licensed by the European Medicines Agency in 2013. We evaluated current practice regarding multiple vaccines and the attitudes of paediatricians towards the 4CMenB before it became available in Austria in 2014. Methods We sent 1624 Austrian paediatricians an email invitation to participate in our nationwide web-based survey and 231 responded. Results Most participants regarded the 4CMenB vaccine as a long-needed and necessary tool against meningococcal B disease. However, most participants would not co-administer this vaccine with other routine infant vaccines. The survey showed that 58.9% of paediatricians already co-administered the hexavalent vaccine with the pneumococcal conjugate vaccine, but most of them would not add a third vaccine at the same visit. This was mainly due to lack of experience with the vaccine and also because they assumed that parents would not consent. Importantly, paediatricians said they wanted an explicit recommendation in the Austrian Immunisation Plan on the timing of the 4CMenB vaccine before they would confidently and routinely use it for infants. Conclusion Paediatricians required more information for themselves and for parents before routinely co-administering the 4CMenB vaccine. They also requested a national recommendation on its timing.

Recently an investigational meningococcal B vaccine has been used in two college outbreaks in the US. This is the first time that a meningococcal B vaccine has been used for outbreak control in the US. However, strain specific vaccines for meningococcal B outbreaks have been developed in Norway, Cuba and to control a large prolonged outbreak in New Zealand. Although meningococcal disease is mostly endemic and baseline rates in the US have fallen over the past decade, outbreaks are not uncommon in the US and globally. In an outbreak, disease risk can rise 1000 fold or more and such outbreaks can last a decade or longer causing significant morbidity and mortality. Here we review the evolution of several serogroup B outbreaks, and, when applicable, the development and impact of meningococcal B vaccines to control these outbreaks. Prior to the availability of “broad spectrum” meningococcal B vaccines, vaccines developed to control meningococcal B outbreaks were strain specific. With the development of two newly licensed meningococcal B vaccines – a four component meningococcal B vaccine (Bexsero®, Novartis) and the two component fHBP vaccine (Trumenba®, Pfizer) that target a broad array of meningococcal B strains, there is now the potential to prevent outbreaks and as well as to shorten the delay between identification of an outbreak and availability of a vaccine.

Recently approved in the EU, US, Australia, and Canada, 4CMenB (Bexsero®, GSK Vaccines) is a multi-component meningococcal B (MenB) vaccine containing 3 surface exposed recombinant proteins (fHbp, NadA, and NHBA) and New Zealand strain outer membrane vesicles (NZ OMV) containing PorA 1.4. The accepted correlate of protection to assess response to MenB vaccines, the serum bactericidal assay with human complement, is impractical for large panels of strains with diverse antigenic profile and expression. Therefore, the Meningococcal Antigen Typing System (MATS) was developed to identify MenB strains with a high likelihood of being covered by 4CMenB. MATS is used to assess MenB strain coverage without requiring sera, an advantage for testing large panels of bacterial isolates. MATS provides an accurate, conservative estimate of 4CMenB coverage. In a public–private partnership, 10 reference laboratories around the world were established and standardized to facilitate the timely collection and analysis of regional data. MATS has global public health implications for informing local policy makers of the predicted effect of the implementation of the 4CMenB vaccine. Coverage estimates are similar to or better than other recently approved vaccines, ranging from 66% to 91%. The use of MATS in post-vaccine implementation surveillance could provide data regarding vaccine effectiveness in the field and duration of protection on a global scale that will aid in the development of vaccine booster schedules, if necessary. This MATS approach could potentially be applied rapidly to assess epidemiology of other bacterial pathogens and coverage by other protein-based vaccines.

Strains of Neisseria meningitidis serogroup B (MenB) causing invasive meningococcal disease are genetically diverse; however, only a small number of hyperinvasive lineages (CC32, CC41/44, CC269 and CC162) have dominated during the global spread over the past 50 years. Since the mid-1970s, major outbreaks and hyperendemic disease have been reported in Norway, Cuba, France, Canada, New Zealand (and elsewhere), most recently in the USA. We characterized the epidemiology of these MenB outbreaks and their associated clonal complexes and retrospectively assessed the potential coverage offered by the 4CMenB vaccine, a four-component vaccine developed to help confer protection against a broad range of meningococcal B strains causing disease. Of 21 isolates from four clonal complexes evaluated using both human Serum Bactericidal Assay and the Meningococcal Antigen Testing System, coverage ranged from 67 to 100%. 4CMenB shows good potential as a candidate vaccine to be used in the control of new MenB outbreaks globally.

Neisseria meningitidisis a Gram-negative pathogen that actively invades its human host and leads to the development of life-threatening pathologies. One of the leading causes of death in the world,N. meningitidiscan be responsible for nearly 1,000 new infections per 100,000 subjects during an epidemic period. The bacterial species are classified into 12 serogroups, five of which (A, B, C, W, and Y) cause the majority of meningitides. The three purified protein conjugate vaccines currently available target serogroups A, C, W, and Y. Serogroup B has long been a challenge but the discovery of the complete genome sequence of an MenB strain has allowed the development of a specific four-component vaccine (4CMenB). This review describes the pathogenetic role ofN. meningitidisand the recent literature concerning the new meningococcal vaccine.

Objective For the decision-making process regarding introduction of new vaccines into the National Immunisation Programme (NIP), advance insight into the potential acceptance among the population is relevant. We studied the intention of parents to have their child vaccinated against four diseases not currently covered by the NIP in the Netherlands. The results on varicella have been published before; this article adds the results on vaccination against rotavirus gastroenteritis, meningococcal B disease, and seasonal influenza. Results We invited a random sample from the national immunisation register of 1500 parents for an internet survey which was completed by 491 parents (33% response). The intention to vaccinate was highest for meningococcal B disease (83% positive intention), followed by rotavirus gastroenteritis (38%), and lowest for varicella (28%) and seasonal influenza (15%). Prediction analyses were performed to determine which out of seven questionnaire statements was most informative in predicting the intention to vaccinate. Main drivers of intention were the perceived importance of vaccination against the particular disease and the perception of whether or not the disease is severe enough to justify vaccination. The results of this study can be informative in the decision-making process whether or not to introduce new vaccines into the NIP. Electronic supplementary material The online version of this article (10.1186/s13104-017-3004-z) contains supplementary material, which is available to authorized users.

Objective To investigate a possible association between fever admissions and 4 component Meningococcal B (4CMenB). Design 4CMenB is given at 8 and 16 weeks in the first year of life. Self-controlled case series using linked routinely collected healthcare data, where the risk period was the 3 days immediately following receipt of a vaccine dose. Patients Children aged under 1 year in Scotland preintroduction and postintroduction of 4CMenB vaccine (pre—September 2014 to August 2015 and post—September 2015 to June 2016). Main outcome measures Hospitalisations for fever attributable to 4CMenB vaccine. Results The postintroduction model showed an increased risk in the 3 days after dose 1 (relative incidence (RI), 10.78; 95% CI: 8.31 to 14.00) and dose 3 (RI, 9.80; 95% CI: 7.10 to 13.62), with a smaller increased risk after dose 2 (RI, 2.20; 95% CI: 1.27 to 3.82). The magnitude of these effects was greater than in the preintroduction model. The attributable fractions were 90.7%, 54.8% and 89.7%, equating to 162, 14 and 84 vaccine attributable cases per 100 000 doses, respectively. This is equivalent to 102 extra hospitalisations in Scotland annually, based on a birth cohort of 55 100 and extrapolated to 1430 across the UK based on a birth cohort of 777 165. Conclusion There is an increased risk of hospital admission with fever within 3 days of the routine childhood immunisations at 8 and 16 weeks following introduction of 4CMenB vaccine. The results indicate that further understanding of the current use of prophylactic paracetamol is needed. Communication to parents and health professionals may also need to be re-examined, and guidance on the use of prophylactic paracetamol reinforced.

Objective To use syndromic surveillance data to assess whether there has been an increase in GP fever consultations since the inclusion of the meningococcal B (MenB) vaccine in the UK vaccination schedule. Introduction From 1 September 2015, babies in the United Kingdom (UK) born on/after 1 July 2015 became eligible to receive the MenB vaccine, given at 2 and 4 months of age, with a booster at 12 months. 1 Early trials found a high prevalence of fever (over 38°C) in babies given the vaccine with other routine vaccines at 2 and 4 months. We used syndromic surveillance 2 data to assess whether there had been increased family doctor (general practitioner (GP)) consultations for fever in young infants following the introduction of the vaccine. Methods GP consultations for fever in infants aged under 1 year were extracted from The Phoenix Partnership (TPP) ResearchOne database (400 GP surgeries in England). 3 Data were stratified by week of age over the period 1 September 2015 to 30 November 2015 and 1 December 2015 to 29 February 2016. Fever consultation rates (per 100,000 registered practice population in the database) were compared to the same 3 month periods of the previous 5 years (2010-14) using incident rate ratios (IRR). Pre- and post-vaccination consultation rates were applied to the England 0-26 week population to estimate excess fever consultations. Results Between 1 September and 30 November 2015 the average daily fever consultation rate for infants aged 0-26 weeks was 4.72/100,000; the incident rate ratio was 1.46 (95% CI, 1.09-1.92). In the 7-10 week age group the average daily fever consultation rate was 7.79/100,000. The incidence rate was 2.68 times higher than in previous years (95% CI, 1.42-4.94). Between 1 December 2015 and 29 February 2016 the average daily consultation rate for infants aged 0-26 weeks was 6.19/100,000. The incidence rate was 1.49 times higher than in the same 3 month period of previous years (95% CI, 1.16-1.90). In infants aged 7-10 weeks the average daily consultation rate was 8.44/100,000 and the incidence rate was 1.83 times higher than previous years (95% CI 1.03-3.16). Between 1 September 2015 and 29 February 2016 there were an estimated additional 959 fever consultations for infants aged 0-26 weeks to English family doctors. Conclusions We have demonstrated an innovative use of syndromic surveillance to quickly and easily assess the impact on healthcare seeking behaviour for infants with fever following the introduction of a new vaccination into the routine vaccination programme in England. Our study provides reassurance that in infants aged 0-26 weeks there was no marked increase in consultations following the introduction of the new MenB vaccination. However, in some age groups below 0-26 weeks there was an increase in healthcare seeking behaviour for fever, in particular, the 7-10 week age group which includes infants aged 8 weeks receiving their first vaccination. Other age groups also demonstrated increased fever consultations during these two periods, albeit at less significant levels. We will analyse data for the full year from 1 September 2015 to further explore these findings, investigate potential confounders and assess trends since vaccine introduction.

Competition among the different classes of genogroups of meningococcal and further bacteria takes place in the ecosystem they constitute within the human body environment. To the best of our knowledge, most of the epidemiological models neglect competition that could highly influence the dynamics of the meningococcal as well as its outbreak. In this paper, we propose a susceptible-carrier-susceptilbe epidemiological model in order to describe the evolution of the percentage of carriers in the population over the time. Moreover, we introduce a competition model to study the dynamics of the meningococcal genogroups in Spain among the carriers. As we are just interested in the meningococcus B, the latter model considers two subpopulations, meningococcal genogroup B and the rest. Both models depend on a number of parameters that are adjusted using real data from the distribution of the genogroups in Spain in years 2011 and 2012. Since these data survey contain sample errors, we further quantify the uncertainties associated to the model parameters taking advantage of a probabilistic fitting method that has been recently proposed by some of the authors. This allows us to give a probabilistic prediction for the evolution of the carriers of the two genogroup over the next few years by constructing a \(95\%\) confidence interval for the percentage of carriers of meningococcus B.

A new meningococcal serogroup B vaccine (4 CMenB) has recently been licensed. This study assessed the acceptability of 4 CMenB vaccine among parents and healthcare workers (HCWs). From May to July 2013 in Milan, Italy, self-administered questionnaires were distributed to 2050 parents of infants presenting at immunization clinics for the mandatory hexavalent vaccination and submitted to 350 HCWs involved in immunization practices. 1842 parents (89.1%) responded to the survey; 64.4% of parents wanted their child to receive the 4 CMenB vaccine and 5.1% would not vaccinate their children. Multivariate analysis showed that recognition of the severity of meningitis [a life threatening vs a mild or unthreatening disease (Odds ratio (OR): 2.3; confidence interval (CI): 1.4-3.6], awareness of vaccination as a beneficial preventive measure (very beneficial vs not beneficial OR = 6.4; CI 3.0-13.7) and knowledge of the Meningococcal C vaccine (OR = 1.4; CI 1.1-1.8) were strongly associated to willingness to receive 4 CMenB vaccine. On the contrary, level of education was associated with refusal of immunization (university vs education level lower than middle school OR = 0.68; CI 0.47-0.97). Among the parents who were willing to immunize their children, 66.9% would agree with three injections to be administered during the same visit. A total of 291 HCWs (83.1%) agreed to participate in the survey; 73% considered 4 CMenB vaccine a priority in infants' immunization schedule; 26.8% of HCWs suggested the concomitant administration with routine infant immunization. Parental and HCWs acceptability of 4 CMenB vaccine was high. Increasing knowledge about meningitis and vaccine prevention might further increase the acceptability of this vaccine.

Immunisation has dramatically reduced the burden of infectious diseases in childhood. Health visitors play a key role in promoting the uptake of immunisations and ensuring that every child benefits from this important public health intervention. The UK childhood immunisation schedule has recently undergone several changes including: a reduction in the number of meningococcal serogroup C conjugate vaccine (MenC) doses given in infancy and the addition of an adolescent booster; the introduction of an oral rotavirus vaccine in infancy; the extension of the influenza vaccination programme to all children ( Hakin et al, 2013a ). Additionally the inclusion of a meningococcal B (MenB) vaccine has been recommended and awaits a date for implementation ( Joint Committee on Vaccination and Immunisation, 2014 ). This article updates health visitors on the recent changes to the routine immunisation schedule and discusses ways in which health visitors can support and advise parents in their decisions regarding immunisation.

Background MenB-FHbp (bivalent rLP2086), a meningococcal serogroup B vaccine, is approved in several countries for adolescents and young adults. MenB-FHbp elicited robust immune responses and had an acceptable safety profile during an extensive clinical development program. Because immune responses to vaccines can vary by subject demographics, this subgroup analysis pooled data across 7 randomized MenB-FHbp clinical studies to evaluate potential differences in immunogenicity by sex, age, or race/ethnicity in a larger dataset relative to individual studies. Methods Data from subjects who received 120 µg MenB-FHbp at 0, 2, and 6 months and had valid immunogenicity results for 4 vaccine-heterologous test strains were included. Immune responses were evaluated by serum bactericidal assays using human complement (hSBA). Immunogenicity endpoints (assessed 1 month after dose 3) were percentages of subjects achieving ≥ 4-fold rise in hSBA titer against each strain, percentages achieving hSBA titers ≥ the lower limit of quantification (LLOQ) against each strain and against all 4 strains combined (composite response), geometric mean hSBA titers against each strain, and percentages achieving hSBA titers ≥ 1:4 (correlate of protection) against each strain. Results This analysis included 8026 subjects aged 10‒25 years (51.7% males, 80.7% adolescents aged 10‒18 years, 87.0% white, 9.3% black, 0.8% Asian, 3.0% other race). One month after dose 3, percentages of subjects achieving a ≥ 4-fold rise from baseline titer against each strain and achieving a composite response were similar across age and race (table). A marginally greater percentage of males vs. females achieved ≥ 4-fold rise in titer against each strain, but these differences were not considered clinically meaningful because of the high percentages of responders in both groups. Conclusion MenB-FHbp immunogenicity was similar across sex, age, and race in this pooled analysis, with high percentages of responders in all evaluated subgroups. The marginally lower response rates among females compared with males were not considered clinically meaningful. These findings support currently recommended MenB-FHbp vaccination practices without modification by sex, age, or race. Funding: Pfizer Disclosures All authors: No reported disclosures.

Efforts to develop vaccines against Neisseria gonorrhoeae have become increasingly important, given the rising threat of gonococcal antimicrobial resistance (AMR). Recent data suggest vaccines for gonorrhoea are biologically feasible; in particular, epidemiological evidence shows that vaccines against a closely related pathogen, serogroup B Neisseria meningitidis outer membrane vesicle (OMV) vaccines, may reduce gonorrhoea incidence. Vaccine candidates using several approaches are currently in preclinical development, including meningococcal and gonococcal OMV vaccines, a lipooligosaccharide epitope and purified protein subunit vaccines. The Global STI Vaccine Roadmap provides action steps to build on this technical momentum and advance gonococcal vaccine development. Better quantifying the magnitude of gonorrhoea-associated disease burden, for outcomes like infertility, and modelling the predicted role of gonococcal vaccines in addressing AMR will be essential for building a full public health value proposition, which can justify investment and help with decision making about future vaccine policy and programs. Efforts are underway to gain consensus on gonorrhoea vaccine target populations, implementation strategies and other preferred product characteristics that would make these vaccines suitable for use in low- and middle-income, as well as high-income, contexts. Addressing these epidemiological, programmatic and policy considerations in parallel to advancing research and development, including direct assessment of the ability of meningococcal B OMV vaccines to prevent gonorrhoea, can help bring about the development of viable gonococcal vaccines.

In developed countries, invasive meningococcal disease (IMD) is a leading infectious cause of death among children. In the UK, Neisseria meningitidis serogroup B is the most frequently identified cause of IMD. This article describes a clinical audit in which early management of IMD is compared with recommendations in the relevant guidelines. It confirms the importance of early recognition of IMD and the need to review previous, less serious diagnoses in ill children. Emergency department nurses play a vital role in the early recognition and management of IMD. Introduction of a meningococcal B vaccine is likely to benefit children in the UK.

La enfermedad meningocócica invasiva, es una infección grave causada “Neisseria meningitidis”. La enfermedad meningocócica invasiva continúa siendo una importante causa de morbimortalidad en todo el mundo, afectando principalmente a niños y adolescentes. En España, desde mediados del siglo XX se han producido varios cambios en su incidencia y variaciones temporales en la proporción de los serogrupos causantes de la enfermedad. En este estudio descriptivo retrospectivo de los niños con edades comprendidas entre los cero y catorce años que precisaron hospitalización en la Unidad de Cuidados Intensivos Pediátricos de Badajoz, entre los años 1997 y 2013 se demuestra que el serogrupo B, es actualmente la causa más frecuente de enfermedad meningocócica invasiva. Además, se observa una disminución de la enfermedad meningocócica invasiva por serogrupo C secundaria a la introducción en el calendario de vacunación sistemática de la vacuna conjugada antimeningocócica C. La estrategia de prevención más efectiva para el control de la enfermedad meningocócica es la vacunación. El desarrollo de las nuevas vacunas frente a meningococo B, es debido a la vacunología inversa, esta nueva estrategia ha sido posible debido al conocimiento de la secuencia completa de del genoma de “Neisseria meningitidis”. Se realiza una revisión sistemática para evaluar la inmunogencidad y seguridad de la vacuna frente a la enfermedad ocasionada por meningococo B disponible para niños., Invasive meningococcal disease is an infection caused by “Neisseria meningitides”. Invasive meningococcal disease remains a major cause of morbimortality worldwide, affecting children and adolescents. in Spain, since the mid-twentieth century there have been some changes in incidence and temporal variations in the proportion of the serogroups causing disease. In this retrospective study of children aged between zero and fourteen years old who required hospitalization in the Pediatric Intensive Care Badajoz between 1997 and 2013 shows that the serogroup B, is currently the most common cause of invasive meningococcal disease. Moreover, a decrease is observed invasive meningococcal disease caused by serogroup C secondary to the introduction in the routine vaccination schedule of the meningococcal C conjugate vaccine. The most effective prevention strategy for controlling meningococcal disease is vaccination. The development of new vaccines against meningococci B, is due to reverse vaccinology, this new strategy has been made possible by the knowledge of the complete genome sequence of “Neisseria meningitides”. A systematic review to evaluate the safety and immunogenicity of the vaccine against the disease caused by meningococci B available for children.

A nation-wide vaccination campaign began in New Zealand in 2004 with the aim of stopping the epidemic of meningococcal B disease. Approximately 80% of those under 20 years of age when the campaign was launched were vaccinated with three doses of a tailor-made vaccine. We propose a framework for a mathematical model based on the susceptible–carrier–infectious–removed (SCIR) structure. We show how the model could be used to calculate the predicted yearly incidence of infection in the absence of vaccination, and compare this to the effect that vaccination had on the course of the epidemic. Our model shows that vaccination led to a considerable decrease in the incidence of infection compared to what would have been seen otherwise. We then use our model to explore the potential effect of alternative vaccination schemes, and show that the one that was implemented was the best of all the possibilities we consider.

Neisseria meningitidis is a leading cause of bacterial sepsis and meningitis worldwide. Invasive meningococcal disease (IMD) can develop rapidly and is associated with high mortality and morbidity. Case fatality in developed countries averages 10% and higher rates are reported in less prosperous regions. The incidence of invasive disease due to Neisseria meningitidis is highly variable according to geographical area and serogroup distribution. The major disease burden is in developing countries; in industrialized countries meningococcal disease occurs sporadically and most IMD is caused by serogroups B and C. In the US serogroup Y is a major cause of meningococcal disease, accounting for more than one third of cases. Polysaccharide vaccines against serogroups A, C, W-135, and Y were developed but they were not so effective in protecting infants, who are at particularly high risk from invasive meningococcal infections. Conjugation of bacterial capsular polysaccharide to a carrier protein generates a T cell dependent immune response and immunological memory from infancy. After the introduction of serogroup C meningococcal conjugate vaccines since 1999, the incidence of serogroup C disease fell dramatically in countries in which they have been used. The first quadrivalent meningococcal conjugate vaccine (MenACWY-D) was licensed in the US in 2005. More recently, another tetravalent meningococcal conjugate vaccine (MenACWY-CRM, Menveo) was licensed in Europe and the US. Although polysaccharide and glycoconjugate vaccines have been developed for serogroups A, C, Y and W-135, currently there are no broadly effective vaccines available for the prevention of meningococcal B disease.

Adrienne Willcox reviews the changes in the epidemiology and treatment of meningococcal disease and the development of a meningococcal B vaccine

Māori and community news constructions of Meningococcal B: The promotion of a moral obligation to vaccinate

Meningococcal antigen typing system (MATS) - the golden standard in many reference labs worldwide–for rapid, reproducible and accurate (conservative nonetheless) prediction of Bexsero strain coverage, can pave the way towards a data-driven decision making of national immunization technical advisory groups (NITAGs), allowing indirect comparison of immunization policies across countries and regions leading to rapid adaptation of public health policy decisions based on worldwide datasets. Нe recent milestone of the UK national infant routine recommendation and reimbursement, paves the way for other nations to follow, bringing closer the pediatric community to the vision of a meningitis free world.

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On 1 September 2015, the UK became the world’s first country to introduce a novel meningococcal B vaccine (Bexsero) into its national childhood immunisation programme. Bexsero is the only market authorised meningococcal B vaccine in the UK. Meningococcal B strains accounts for ~80% of all laboratory confirmed cases of invasive meningococcal disease (IMD) in England and Wales.1 Bexsero is estimated to protect against 73%–88% of the meningococcal B strains causing invasive disease in England and Wales.2 After observing more instances of clinical instability in our immunised neonates following the introduction of the new …

Incidence of invasive meningococcal disease is low in Germany at 0.5 cases/100,000 inhabitants. Serogroup B (MenB) is most common, causing 70% of cases, with highest incidence in infants (5.9/100,000). In 2013, a MenB vaccine was licensed in Europe. To assess pediatricians’ attitudes towards MenB vaccination and its potential use in Germany we conducted a nationwide cross-sectional survey among 5677 pediatricians. Of 3107 participants (response: 55%), 79.1% would recommend a MenB vaccination to parents, with 66.7% favoring a schedule at 6, 8 and 12 months over 2, 3, 4 and 12 months (13.4%). Administration separately from other vaccines was preferred (63.2%); 38.5% feared that a recommendation would lead to refusal of other recommended vaccinations. In conclusion, pediatricians showed distinct preferences regarding possible integration of MenB vaccination into the existent immunization schedule. As physicians play a crucial role in the implementation, findings will be useful in decision-making regarding potential introduction.

Background PorA, fetA and fHbp are three antigen encoding genes useful for meningococcal typing and FHbp is an important component of meningococcal B vaccines. Methods We performed sequence analysis of meningococcal porA, fetA and fHbp genes on 128 isolates from Western Australia, relating results to age, gender, race and geographic region. Results We found predominantly PorA subtypes P1.22,14-16 (n = 23) and P1.7-2,4 (n = 19); FetA subtypes F1-5 (n = 41), F3-6 (n = 11), F5-1 (n = 10), F5-2 (n = 9), F5-5 (n = 8), F3-3 (n = 8); and FHbp variant groups 1 (n = 65) and 2 (n = 44). PorA P1.22,14-16 and FHbp variant group 2 were associated with younger age and aboriginality. Conclusions FHbp modular groups of the bivalent recombinant FHbp vaccine and the multicomponent 4CMenB vaccine make up 8.3% and 47.7% respectively of the examined serogroup B isolates from 2000–2011, however to estimate vaccine efficacy requires an account of all vaccine antigens and their levels of expression. Electronic supplementary material The online version of this article (doi:10.1186/s12879-014-0686-x) contains supplementary material, which is available to authorized users.

Vaccination is among the most effective public health interventions of the past century, with immunisations against some of the most common and devastating childhood infections already in use to great effect. The development of new vaccines depends on advances in the field of vaccinology that carry high monetary costs. In most countries, these costs pose an obstacle to adoption of new vaccines. To that end, together with the scientific evaluation of new vaccines, an economic evaluation is vital. This aims to determine whether investment in the proposed vaccine is worthwhile. In this article, we will examine one such case study: the evaluation of a new meningococcal B (MenB) vaccine in the UK by the Joint Committee on Vaccination and Immunization (JCVI). We are well aware of the constraints imposed by a definite health budget; at the same time, we would like to raise awareness to the problems inherent in and the somewhat speculative nature of the economic model when applied to vaccine evaluation. Though some of the aspects of this case are specific to the UK, the principles of this evaluation are relevant to all modern health systems. In March 2014, JCVI made public its decision to support the introduction of a MenB vaccine (Bexsero) that had been licensed for use in Europe the year before.1 ,2 JCVI recommended that the vaccine should be introduced into the UK routine infant immunisation schedule if the appropriate price per vaccine dose could be negotiated. This decision is welcome news to the medical profession, to meningitis patients’ advocacy groups, to the population in general and to the vaccine manufacturers. The process by which Bexsero was recommended highlighted the central role that health economics and cost-effectiveness analysis play in such decisions. The difficulties that JCVI faced when reaching its eventual decision suggest …