Menveo®: a novel quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135 and Y

Meningococcal disease remains a global public health concern despite the wide availability of polysaccharide and polysaccharide–protein conjugate vaccines. The latter often afford a greater duration and scope of protection compared with the former. A novel quadrivalent meningococcal conjugate vaccine, Menveo® (MenACWY-CRM; Novartis Vacines, Bellaria-Rosia, Italy) has recently been licensed in Europe, the USA, Canada and other countries to protect adolescents and adults against disease caused by serogroups A, C, W-135 and Y. MenACWY-CRM has an immunogenicity and tolerability profile in adolescents and adults supported by an extensive clinical development program. MenACWY-CRM induced immune responses that were at least as good as those induced by Menactra® (MenACWY-D; Sanofi Pasteur [Swiftwater, PA, USA]), a quadrivalent meningococcal polysaccharide–protein conjugate vaccine) against serogroups A, C, W-135 and Y. Immune responses were also observed in a population of subjects 56–65 years of age. Published information also shows immunogenicity in infants, toddlers and children. Tolerability outcomes were similar for MenACWY-CRM, MenACWY-D and a plain polysaccharide quadrivalent vaccine against meningococcal serogroups A, C, W-135 and Y. Given its potential for protecting infants and persons over 55 years of age, MenACWY-CRM offers promise to fulfil an unmet global need for preventing invasive meningococcal disease in vulnerable populations for which no vaccine is available.

[1]  K. Claflin,et al.  Chronic meningococcemia. , 1984, Wisconsin medical journal.

[2]  Sullivan Td,et al.  Neisseria meningitidis bacteremia in children: quantitation of bacteremia and spontaneous clinical recovery without antibiotic therapy. , 1987 .

[3]  T. Sullivan,et al.  Neisseria meningitidis bacteremia in children: quantitation of bacteremia and spontaneous clinical recovery without antibiotic therapy. , 1987, Pediatrics.

[4]  C. Frasch.  Vaccines for prevention of meningococcal disease , 1989, Clinical Microbiology Reviews.

[5]  E. Zell,et al.  Decline of childhood Haemophilus influenzae type b (Hib) disease in the Hib vaccine era. , 1993, JAMA.

[6]  M. Gahr,et al.  Clinical experience of a tricomponent acellular pertussis vaccine combined with diphtheria and tetanus toxoids for primary vaccination in 22,505 infants. , 1996, The Journal of pediatrics.

[7]  G. Carlone,et al.  Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. The Multilaboratory Study Group , 1997, Clinical and diagnostic laboratory immunology.

[8]  D. Fleming,et al.  Tobacco smoke as a risk factor for meningococcal disease. , 1997, The Pediatric infectious disease journal.

[9]  P. Cieslak,et al.  Capsule switching of Neisseria meningitidis. , 1997, Proceedings of the National Academy of Sciences of the United States of America.

[10]  G. Carlone,et al.  Standardization and a Multilaboratory Comparison ofNeisseria meningitidisSerogroup A and C Serum Bactericidal Assays , 1997 .

[11]  B. Perkins,et al.  Control and prevention of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). , 1997, MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports.

[12]  P. De Wals,et al.  Complications and sequelae of meningococcal disease in Quebec, Canada, 1990-1994. , 1998, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[13]  J. Stuart,et al.  Outbreak of meningococcal disease linked to a sports club , 1998, The Lancet.

[14]  R. Rochat,et al.  Maternal cigarette smoking and invasive meningococcal disease: a cohort study among young children in metropolitan Atlanta, 1989-1996. , 1999, American journal of public health.

[15]  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.

[16]  B Kriz,et al.  Parental smoking, socioeconomic factors, and risk of invasive meningococcal disease in children: a population based case-control study , 2000, Archives of disease in childhood.

[17]  W. Blackwelder,et al.  Importance of Complement Source in Measuring Meningococcal Bactericidal Titers , 2001, Clinical Diagnostic Laboratory Immunology.

[18]  Meningococcal disease, serogroup W135 (update). , 2001, Releve epidemiologique hebdomadaire.

[19]  L. Harrison,et al.  Cluster of Serogroup C Meningococcal Disease Associated With Attendance at a Party , 2001, Southern medical journal.

[20]  B. Feighner,et al.  Meningococcal disease among United States military service members in relation to routine uses of vaccines with different serogroup-specific components, 1964-1998. , 2002, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[21]  J. Weinberg,et al.  Detection and response to a meningococcal disease outbreak following a youth football tournament with teams from four European countries. , 2002, International journal of hygiene and environmental health.

[22]  N. Andrews,et al.  Effect of Vaccination with Carrier Protein on Response to Meningococcal C Conjugate Vaccines and Value of Different Immunoassays as Predictors of Protection , 2002, Infection and Immunity.

[23]  M. Goldacre,et al.  Case fatality rates for meningococcal disease in an English population, 1963-98: database study , 2003, BMJ : British Medical Journal.

[24]  Steven Black,et al.  Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. , 2003, The Journal of pediatrics.

[25]  A. Schuchat,et al.  Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. , 2003, The New England journal of medicine.

[26]  H. Sørensen,et al.  Fetal growth, maternal prenatal smoking, and risk of invasive meningococcal disease: a nationwide case-control study. , 2004, International journal of epidemiology.

[27]  I. Pereiró,et al.  Risk factors for invasive disease among children in Spain. , 2004, The Journal of infection.

[28]  C. Hart,et al.  Meningococcal Disease , 1974, Nursing standard (Royal College of Nursing (Great Britain) : 1987).

[29]  B. McCall,et al.  Risk factors for invasive meningococcal disease in southern Queensland, 2000−2001 , 2004, Internal medicine journal.

[30]  N. Benowitz,et al.  Cigarette smoking and infection. , 2004, Archives of internal medicine.

[31]  H. Keyserling,et al.  Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. , 2005, Archives of pediatrics & adolescent medicine.

[32]  E. Miller,et al.  Meningococcal surrogates of protection--serum bactericidal antibody activity. , 2005, Vaccine.

[33]  S. Tyler,et al.  Potential capsule switching from serogroup Y to B: The characterization of three such Neisseria meningitidis isolates causing invasive meningococcal disease in Canada. , 2005, The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale.

[34]  H. D. de Melker,et al.  Ascertainment of meningococcal disease in Europe. , 2005, Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin.

[35]  O. Leavy,et al.  Modified Bacterial Toxins , 2006 .

[36]  P. Gardner.  Prevention of Meningococcal Disease , 2006 .

[37]  R. Rappuoli,et al.  A universal vaccine for serogroup B meningococcus. , 2006, Proceedings of the National Academy of Sciences of the United States of America.

[38]  M. Taha,et al.  Conserved virulence of C to B capsule switched Neisseria meningitidis clinical isolates belonging to ET-37/ST-11 clonal complex. , 2006, Microbes and infection.

[39]  P. Gardner.  Clinical practice. Prevention of meningococcal disease. , 2006, The New England journal of medicine.

[40]  M. Kieny,et al.  A review of vaccine research and development: meningococcal disease. , 2006, Vaccine.

[41]  C. Stratton,et al.  Clonal Spread of Serogroup W135 Meningococcal Disease in Turkey , 2006, Journal of Clinical Microbiology.

[42]  J. L. Woodard,et al.  PREVENTION OF MENINGOCOCCAL DISEASE , 2006, Fetal and pediatric pathology.

[43]  R. Perera,et al.  Clinical recognition of meningococcal disease in children and adolescents , 2006, The Lancet.

[44]  Ross Gagliano,et al.  Review of , 2006, UBIQ.

[45]  Malcolm Guiver,et al.  Epidemiology of meningococcal disease in England and Wales 1993/94 to 2003/04: contribution and experiences of the Meningococcal Reference Unit. , 2006, Journal of medical microbiology.

[46]  D. Stephens.  Conquering the meningococcus. , 2007, FEMS microbiology reviews.

[47]  J. Holst.  Strategies for Development of Universal Vaccines Against Meningococcal Serogroup B Disease , 2007, Human vaccines.

[48]  M. Steinhoff,et al.  Global epidemiology of meningococcal infections. , 2007 .

[49]  J. Caro,et al.  Invasive meningococcal disease epidemiology and control measures: a framework for evaluation , 2007, BMC public health.

[50]  B. Greenwood,et al.  Epidemic meningitis, meningococcaemia, and Neisseria meningitidis , 2007, The Lancet.

[51]  憲 大久保.  Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings 2007 , 2008 .

[52]  C. I. Agudelo,et al.  Serogroup Y Meningococcal Disease, Colombia , 2008, Emerging infectious diseases.

[53]  Recommended immunization schedule for persons aged 7-18 years--United States 2008. , 2008, South Dakota medicine : the journal of the South Dakota State Medical Association.

[54]  C. Soskolne,et al.  Modifiable Risk Factors for Invasive Meningococcal Disease During an Edmonton, Alberta Outbreak, 1999–2002 , 2008, Canadian journal of public health = Revue canadienne de sante publique.

[55]  S. Ram,et al.  Binding of Complement Factor H (fH) to Neisseria meningitidis Is Specific for Human fH and Inhibits Complement Activation by Rat and Rabbit Sera , 2008, Infection and Immunity.

[56]  A. Wilder-Smith.  Meningococcal disease: risk for international travellers and vaccine strategies. , 2008, Travel medicine and infectious disease.

[57]  D. Crook,et al.  Impact of meningococcal serogroup C conjugate vaccines on carriage and herd immunity. , 2008, The Journal of infectious diseases.

[58]  S. Schrag,et al.  Emergence of endemic serogroup W135 meningococcal disease associated with a high mortality rate in South Africa. , 2008, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[59]  M. J. Simões,et al.  Molecular surveillance of Neisseria meningitidis capsular switching in Portugal, 2002–2006 , 2008, Epidemiology and Infection.

[60]  J. Langley,et al.  Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. , 2008, JAMA.

[61]  A. Wilder-Smith.  Meningococcal vaccines: a neglected topic in travel medicine? , 2009, Expert review of vaccines.

[62]  Lee H Harrison,et al.  Global epidemiology of meningococcal disease. , 2009, Vaccine.

[63]  K. Reisinger,et al.  A Randomized Trial to Determine the Tolerability and Immunogenicity of a Quadrivalent Meningococcal Glycoconjugate Vaccine in Healthy Adolescents , 2009, The Pediatric infectious disease journal.

[64]  S. Halperin,et al.  The Impact of Childhood Meningococcal Serogroup C Conjugate Vaccine Programs in Canada , 2009, The Pediatric infectious disease journal.

[65]  R. Booy,et al.  Influenza and meningococcal disease: lessons for travellers and government from 2 epidemic diseases. , 2009, Travel medicine and infectious disease.

[66]  D. Pace.  Quadrivalent meningococcal ACYW-135 glycoconjugate vaccine for broader protection from infancy , 2009, Expert review of vaccines.

[67]  K. Reisinger,et al.  Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. , 2009, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[68]  S. Halperin,et al.  Safety and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine after one or two doses given to infants and toddlers , 2010, European Journal of Clinical Microbiology & Infectious Diseases.

[69]  J. Donnelly,et al.  Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease. , 2009, Vaccine.

[70]  D. Granoff,et al.  Ex Vivo Model of Meningococcal Bacteremia Using Human Blood for Measuring Vaccine-Induced Serum Passive Protective Activity , 2009, Clinical and Vaccine Immunology.

[71]  Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for revaccination of persons at prolonged increased risk for meningococcal disease. , 2009, MMWR. Morbidity and mortality weekly report.

[72]  R. Rappuoli,et al.  Chemistry of a new investigational quadrivalent meningococcal conjugate vaccine that is immunogenic at all ages. , 2009, Vaccine.

[73]  M. Maiden,et al.  Meningococcal vaccines and herd immunity: lessons learned from serogroup C conjugate vaccination programs , 2009, Expert review of vaccines.

[74]  An update on the invasive meningococcal disease and meningococcal vaccine conjugate recommendations. An Advisory Committee Statement (ACS). , 2009, Canada communicable disease report = Releve des maladies transmissibles au Canada.

[75]  R. Borrow.  Meningococcal disease and prevention at the Hajj. , 2009, Travel medicine and infectious disease.

[76]  O. Levine,et al.  Sequelae due to bacterial meningitis among African children: a systematic literature review , 2009, BMC medicine.

[77]  A. Pollard,et al.  Quadrivalent meningococcal conjugate vaccines. , 2009, Vaccine.

[78]  C. Speil.  Emergence of Ciprofloxacin-Resistant Neisseria meningitidis in North America , 2009 .

[79]  N. Wood,et al.  MODERN TRENDS IN MORTALITY FROM MENINGOCOCCAL DISEASE IN AUSTRALIA , 2009, The Pediatric infectious disease journal.

[80]  R. Siam,et al.  Prevalence and antimicrobial resistance pattern of bacterial meningitis in Egypt , 2009, Annals of Clinical Microbiology and Antimicrobials.

[81]  K. Reisinger,et al.  Quadrivalent Meningococcal Vaccination of Adults: Phase III Comparison of an Investigational Conjugate Vaccine, MenACWY-CRM, with the Licensed Vaccine, Menactra , 2009, Clinical and Vaccine Immunology.

[82]  J. Kroll,et al.  Evidence for Capsule Switching between Carried and Disease-Causing Neisseria meningitidis Strains , 2009, Infection and Immunity.

[83]  J. Vázquez,et al.  W135 Invasive Meningococcal Strains Spreading in South America: Significant Increase in Incidence Rate in Argentina , 2009, Journal of Clinical Microbiology.

[84]  Rino Rappuoli,et al.  Vaccinology in the genome era. , 2009, The Journal of clinical investigation.

[85]  Statement on meningococcal vaccination for travellers. An Advisory Committee Statement (ACS). , 2009, Canada communicable disease report = Releve des maladies transmissibles au Canada.

[86]  P. Dull,et al.  Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. , 2010, Vaccine.

[87]  Lei Wang,et al.  Genetic Study of Capsular Switching between Neisseria meningitidis Sequence Type 7 Serogroup A and C Strains , 2010, Infection and Immunity.

[88]  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.

[89]  C. Gill,et al.  Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents , 2010, Human vaccines.

[90]  M. Virji,et al.  Cellular and molecular biology of Neisseria meningitidis colonization and invasive disease , 2010, Clinical science.

[91]  Jane W. Marsh,et al.  Population structure and capsular switching of invasive Neisseria meningitidis isolates in the pre-meningococcal conjugate vaccine era--United States, 2000-2005. , 2010, The Journal of infectious diseases.

[92]  W. Hitchcock,et al.  Epidemiology and Meningococcal Serogroup Distribution in the United States , 2010, Clinical pediatrics.

[93]  J. Zuckerman,et al.  2010 FIFA world cup South Africa: travel health issues and new options for protection against meningococcal disease. , 2010, Travel medicine and infectious disease.

[94]  G. Poland.  Prevention of meningococcal disease: current use of polysaccharide and conjugate vaccines. , 2010, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[95]  S. Black,et al.  Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. , 2010, Vaccine.

[96]  G. Carlone,et al.  Advances in the development of vaccines against Neisseria meningitidis. , 2010, The New England journal of medicine.

[97]  I. Rudan,et al.  Global and regional risk of disabling sequelae from bacterial meningitis: a systematic review and meta-analysis. , 2010, The Lancet. Infectious diseases.

[98]  T. Doyle,et al.  Cluster of Serogroup W135 Meningococci, Southeastern Florida, 2008–2009 , 2010, Emerging infectious diseases.

[99]  Licensure of a meningococcal conjugate vaccine (Menveo) and guidance for use - Advisory Committee on Immunization Practices (ACIP), 2010. , 2010, MMWR. Morbidity and mortality weekly report.

[100]  L. Harrison.  Epidemiological profile of meningococcal disease in the United States. , 2010, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[101]  H. Fredlund,et al.  Isolation and characterization of Neisseria meningitidis in the vaccine era. Who needs what and when? , 2010, Scandinavian journal of infectious diseases.

[102]  P. Dull,et al.  Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. , 2010, International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases.

[103]  L. Harrison,et al.  Meningococcal group A, C, Y and W-135 conjugate vaccine , 2010, Nature Reviews Drug Discovery.

[104]  N. Fishman,et al.  Healthcare Infection Control Practices Advisory Committee , 2012 .

[105]  Peltola,et al.  Control of Epidemic Meningococcal Disease. Who Practical Guidelines. 2 World Health Organization Emerging and Other Communicable Diseases, Surveillance and Control Editorial Working Group Preface (edition 1) Preface (edition 1) , 2022 .