First Use of a Serogroup B Meningococcal Vaccine in the US in Response to a University Outbreak

BACKGROUND: In 2013–2014, an outbreak of serogroup B meningococcal disease occurred among persons linked to a New Jersey university (University A). In the absence of a licensed serogroup B meningococcal (MenB) vaccine in the United States, the Food and Drug Administration authorized use of an investigational MenB vaccine to control the outbreak. An investigation of the outbreak and response was undertaken to determine the population at risk and assess vaccination coverage. METHODS: The epidemiologic investigation relied on compilation and review of case and population data, laboratory typing of meningococcal isolates, and unstructured interviews with university staff. Vaccination coverage data were collected during the vaccination campaign held under an expanded-access Investigational New Drug protocol. RESULTS: Between March 25, 2013, and March 10, 2014, 9 cases of serogroup B meningococcal disease occurred in persons linked to University A. Laboratory typing results were identical for all 8 isolates available. Through May 14, 2014, 89.1% coverage with the 2-dose vaccination series was achieved in the target population. From the initiation of MenB vaccination through February 1, 2015, no additional cases of serogroup B meningococcal disease occurred in University A students. However, the ninth case occurred in March 2014 in an unvaccinated close contact of University A students. CONCLUSIONS: No serogroup B meningococcal disease cases occurred in persons who received 1 or more doses of 4CMenB vaccine, suggesting 4CMenB may have protected vaccinated individuals from disease. However, the ninth case demonstrates that carriage of serogroup B Neisseria meningitidis among vaccinated persons was not eliminated.

[1]  S. Faust,et al.  Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial , 2014, The Lancet.

[2]  S. Stokley,et al.  National and State Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2012 , 2013, MMWR. Morbidity and mortality weekly report.

[3]  M. Valenzuela,et al.  Persistence of antibodies in adolescents 18−24 months after immunization with one, two, or three doses of 4CMenB meningococcal serogroup B vaccine , 2013, Human vaccines & immunotherapeutics.

[4]  M. Valenzuela,et al.  Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study , 2012, The Lancet.

[5]  National and state vaccination coverage among adolescents aged 13-17 years--United States, 2011. , 2012, MMWR. Morbidity and mortality weekly report.

[6]  Nicole Wolter,et al.  Clinical Validation of Multiplex Real-Time PCR Assays for Detection of Bacterial Meningitis Pathogens , 2011, Journal of Clinical Microbiology.

[7]  R. Rappuoli,et al.  Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the United States. , 2011, Vaccine.

[8]  Xin Wang,et al.  sodC-Based Real-Time PCR for Detection of Neisseria meningitidis , 2011, PloS one.

[9]  R. Rappuoli,et al.  Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines , 2010, Proceedings of the National Academy of Sciences.

[10]  R. Rappuoli,et al.  Measuring antigen-specific bactericidal responses to a multicomponent vaccine against serogroup B meningococcus. , 2010, Vaccine.

[11]  W. Schaffner,et al.  Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. , 2010, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[12]  K. Jolley,et al.  Clonal Distribution of Disease-Associated and Healthy Carrier Isolates of Neisseria meningitidis between 1983 and 2005 in Cuba , 2009, Journal of Clinical Microbiology.

[13]  Tanja Popovic,et al.  Use of Real-Time PCR To Resolve Slide Agglutination Discrepancies in Serogroup Identification of Neisseria meningitidis , 2004, Journal of Clinical Microbiology.

[14]  T. Popović,et al.  Use of Real-Time PCR To Resolve Slide Agglutination Discrepancies in Serogroup Identification of Neisseria meningitidis , 2003 .

[15]  Z. Mulla,et al.  Meningococcal disease in college students. , 2001, JAMA.

[16]  J. Capparella,et al.  Risk factors for meningococcal disease in college students. , 2001, JAMA.

[17]  T. Popović,et al.  Evaluation of Pulsed-Field Gel Electrophoresis in Epidemiological Investigations of Meningococcal Disease Outbreaks Caused byNeisseria meningitidis Serogroup C , 2001, Journal of Clinical Microbiology.

[18]  Oleg O. Bilukha,et al.  Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). , 2000, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[19]  T. Popović,et al.  Diversity and prevalence of PorA types in Neisseria meningitidis serogroup B in the United States, 1992-1998. , 2000, The Journal of infectious diseases.

[20]  B. Perkins,et al.  Meningococcal disease and college students. Recommendations of the Advisory Committee on Immunization Practices (ACIP). , 2000, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[21]  J. Nguyen-Van-Tam,et al.  Invasive meningococcal disease among university undergraduates: association with universities providing relatively large amounts of catered hall accommodation , 1999, Epidemiology and Infection.

[22]  L. Harrison,et al.  Risk of meningococcal infection in college students. , 1999, JAMA.

[23]  M. Achtman,et al.  Multilocus sequence typing: a portable approach to the identification of clones within populations of pathogenic microorganisms. , 1998, Proceedings of the National Academy of Sciences of the United States of America.

[24]  A. Schuchat,et al.  Serogroup C meningococcal outbreaks in the United States. An emerging threat. , 1995, JAMA.