Background Paper for the update of meningococcal vaccination recommendations in Germany: use of the serogroup B vaccine in persons at increased risk for meningococcal disease.

In December 2013 Bexsero® became available in Germany for vaccination against serogroup B meningococci (MenB). In August 2015 the German Standing Committee on Vaccination (STIKO) endorsed a recommendation for use of this vaccine in persons at increased risk of invasive meningococcal disease (IMD). This background paper summarizes the evidence underlying the recommendation. Bexsero® is based on surface protein antigens expressed by about 80% of circulating serogroup B meningococci in Germany. The paper reviews available data on immunogenicity and safety of Bexsero® in healthy children and adolescents; data in persons with underlying illness and on the effectiveness in preventing clinical outcomes are thus far unavailable.STIKO recommends MenB vaccination for the following persons based on an individual risk assessment: (1) Persons with congenital or acquired immune deficiency or suppression. Among these, persons with terminal complement defects and properdin deficiency, including those under eculizumab therapy, are at highest risk with reported invasive meningococcal disease (IMD) incidences up 10,000-fold higher than in the general population. Persons with asplenia were estimated to have a ~ 20-30-fold increased risk of IMD, while the risk in individuals with other immune defects such as HIV infection or hypogammaglobulinaemia was estimated at no more than 5-10-fold higher than the background risk. (2) Laboratory staff with a risk of exposure to N. meningitidis aerosols, for whom an up to 271-fold increased risk for IMD has been reported. (3) Unvaccinated household (-like) contacts of a MenB IMD index case, who have a roughly 100-200-fold increased IMD risk in the year after the contact despite chemoprophylaxis. Because the risk is highest in the first 3 months and full protective immunity requires more than one dose (particularly in infants and toddlers), MenB vaccine should be administered as soon as possible following identification of the serogroup of the index case.

Preventive medicines: vaccination, prophylaxis of infectious diseases, disinfectants.

Immunizations belong to the most successful interventions in medicine. Like other drugs, vaccines undergo long periods of pre-clinical development, followed by careful clinical testing through study Phases I, II, and III before they receive licensure. A successful candidate vaccine will move on to be an investigational vaccine to undergo three phases of pre-licensure clinical trials in a stepwise fashion before it can be considered for approval, followed by an optional fourth phase of post-marketing assessment. The overall risk-benefit assessment of a candidate vaccine is very critical in making the licensure decision for regulatory authorities, supported by their scientific committees. It includes analyses of immunogenicity, efficacy, reactogenicity or tolerability, and safety of the vaccine. Public trust in vaccines is a key to the success of immunization programs worldwide. Maintaining this trust requires knowledge of the benefits and scientific understanding of real or perceived risks of immunizations. Under certain circumstances, pre- or post-exposure passive immunization can be achieved by administration of immunoglobulines. In terms of prevention of infectious diseases, disinfection can be applied to reduce the risk of transmission of pathogens from patient to patient, health-care workers to patients, patients to health-care workers, and objects or medical devices to patients.

Intussusception: incidence and treatment-insights from the nationwide German surveillance.

OBJECTIVE: Intussusception (IS) is one of the most common paediatric emergencies, and the best mode of conservative reduction and its exact incidence remains unclear. For different reasons, availability of reliable incidence data are useful and additionally may be fundamental to monitor potential effects of recently introduced rotavirus (RV) vaccines. METHODS: We performed a prospective German nationwide surveillance between January 1, 2006 and December 31, 2007, followed by separate collection of all IS cases in a random sample of 31 clinics for an unbiased estimation of underreporting. For case definition, the Brighton Collaboration (BC) criteria were applied. RESULTS: A total of 1200 children with at least 1 episode of IS were included. For children younger than 1 year the incidence was calculated to be 60.4/100,000 child-years. The risk for surgery increased 2-fold if the interval between onset of symptoms and first attempt of conservative reduction exceeded 5 hours (95% confidence interval [CI] 1.2-3.1). We also observed a 2.8-fold increased risk for surgery for hydrostatic (CI 1.2-6.4) and a 3.7-fold for barium enema reduction (CI 1.6-8.8) compared to pneumatic reduction. The level of specialisation of the hospital did not influence the success of conservative management. CONCLUSIONS: For children with IS a fast attempt of pneumatic reduction seems to be the optimal management. Considering the current practice we estimated that approximately 104 (CI 46-161) surgical interventions would be preventable in Germany every year. Also, conduction of reliable postmarketing monitoring of the new RV vaccines is now possible based on the provided incidence data.

Three-year surveillance of intussusception in children in Switzerland.

OBJECTIVE: We attempted to obtain baseline data on the incidence of intussusception and its association with gastroenteritis in a cross-sectional observational study in children. METHODS: Admissions to all 38 pediatric units in Switzerland because of intussusception were reported to the Swiss Pediatric Surveillance Unit from April 2003 to March 2006. Patient and disease characteristics were assessed prospectively with the use of a standardized questionnaire based on the case definition for intussusception developed by the Brighton Collaboration. Completeness of reporting was verified through capture-recapture analysis. RESULTS: There were 294 patients with reported intussusception; 35 cases were excluded for various reasons, and 29 additional patients were identified through International Classification of Diseases, 10th Revision, codes. After capture-recapture analysis, we estimated underreporting to the Swiss Pediatric Surveillance Unit to be 32% and we calculated a true number of 381 intussusception episodes. The highest level of diagnostic certainty was reached by 248 patients, and 20 fulfilled level 2 criteria; for the remaining 20 patients, available information was insufficient. The mean age of the patients was 2.7 years. The yearly mean incidence of intussusception was 38, 31, and 26 cases per 100,000 live births in the first, second, and third year of life, respectively, with no apparent seasonality. Seventy patients had a history of coinciding gastroenteritis, and 5 of 61 tested positive for rotavirus. Spontaneous devagination was observed for 38 patients; enemas reduced intussusception successfully in 183 cases, whereas surgical treatment was required in 67. All patients recovered without sequelae. CONCLUSIONS: This is the first prospective nationwide surveillance of intussusception in childhood using a standardized case definition. Most cases occurred beyond infancy, and association with rotavirus gastroenteritis was rare.