Sex: U
Vaccine: MEN, UNK
Symptoms: Meningococcal infection, Neisseria test positive, Vaccination failure
Clinical narrative: Vaccination failure; Meningococcal B disease; This case was reported in a literature article and described the occurrence of vaccination failure in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  Co-suspect products included eculizumab for an unknown indication.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose and eculizumab at an unknown dose and frequency. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria GSK medically significant). The action taken with eculizumab was unknown. On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown.   It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to Meningococcal B vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the suspected vaccination failure in a patient of unspecified age and gender, who was vaccinated with unspecified meningococcal B vaccine (manufacturer unknown) for prophylaxis.  The patient was a part of study that aimed on potential risks and benefits of antibiotic prophylaxis for the prevention of meningococcal disease in a case series of vaccinated eculizumab recipients who developed meningococcal disease. [In this study, the meningococcal disease cases in eculizumab recipients were searched in the FDA Adverse Event Reporting System (FAERS) and the literature between March 2007 and May 2017]. The patient received eculizumab within 3 months preceding a diagnosis of meningococcal disease (indication: 6 patients due to paroxysmal nocturnal hemoglobinuria (NH); 7 patients due to atypical hemolytic uremic syndrome (aHUS) and 2 patients due to membranoproliferative glomerulonephritis or C3 glomerulopathy). The patient was on antibiotic prophylaxis (out of 15, 14 patients were taking penicillin and 1 was taking amoxicillin). No information on patient's medical or family history or concurrent condition was provided. On an unspecified date, the patient received more than or equal to 1 dose of unspecified meningococcal B vaccine, (administration route and site unspecified; batch number not provided). Age at vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was symptomatic (unspecified) with a positive culture or other confirmatory test for N. meningitidis from any body site. The patient was diagnosed with Meningococcal B disease. No death due to meningococcal disease was reported. [In this study, Three of 47 patients had more than equal to 1 episode of meningococcal disease (two patients were taking prophylaxis; one was not). Time to onset (TTO) was calculated from the date of first eculizumab dose (assumed to be the date of starting antibiotic prophylaxis) to the date of the patient's first meningococcal disease episode. For patients with multiple episodes of meningococcal disease, the calculations described below were performed using only the first meningococcal disease episode. TTO of first episode of meningococcal disease was reported for 11 of 15 patients taking prophylaxis. Median TTO of first episode of meningococcal disease was 835 days in prophylaxis recipients versus]. This case has been considered as suspected vaccination failure being time to onset, full schedule was unknown. This case has been considered as serious due to suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The authors commented, "in this descriptive analysis we observed a prolonged TTO of first meningococcal disease episode and a higher frequency of reduced penicillin susceptibility among prophylaxis users compared to non-prophylaxis users (all previously vaccinated). Although these results suggest that antibiotic prophylaxis may delay TTO, prescribers should interpret these findings conservatively, particularly given the wide range of TTO and the substantial differences in patient age and country of residence between prophylaxis recipients and non-prophylaxis recipients. When considering the benefit-risk balance of prophylaxis use, the more frequent reports of reduced penicillin susceptibility among prophylaxis users deserve comment. If this is a true relationship, colonization by meningococcal isolates with reduced penicillin susceptibility may have precluded penicillin from preventing meningococcal disease. Reduced penicillin susceptibility could be a consequence of selective antibiotic pressure. Further complicating use of prophylaxis, eculizumab recipients are also at risk for disseminated Neisseria gonorrhoeae, 3 an organism in which penicillin resistance is common. Overall, the data are inconclusive. However, we did observe a trend towards prolonged TTO among prophylaxis users but also towards increased penicillin non-susceptibility among prophylaxis recipients. Validation of these potential associations in a larger sample, with systematic ascertainment of antibiotic exposure, could further elucidate the potential impact of prophylaxis on development of meningococcal disease among eculizumab recipients. Healthcare professionals should remain vigilant for signs of meningococcal disease among eculizumab recipients, irrespective of the preventive measures in use".      Lab Comments: Lab test done on an unknown date between March 2007 and May 2017.