Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy

Clinical Infectious Diseases

Volumn 51, Issue 10, 2010, Pages 1127-1137

  Findlow, Jamie ^a   Borrow, Ray ^a   Snape, Matthew D ^b   Dawson, Tom ^b   Holland, Ann ^a   John, Tessa M ^b   Evans, Anita ^b   Telford, Karen L ^a   Ypma, Ellen ^c   Toneatto, Daniela ^d   Oster, Philipp ^d   Miller, Elizabeth ^a   Pollard, Andrew J ^b  

^a PUBLIC HEALTH ENGLAND   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c Novartis Vaccines   (Netherlands)

^d NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

MENINGOCOCCUS VACCINE; RECOMBINANT MENINGOCOCCAL SEROGROUP B VACCINE; RECOMBINANT VACCINE; UNCLASSIFIED DRUG;

ARTICLE; BACTERIAL INFECTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG FORMULATION; DRUG SAFETY; FEMALE; FEVER; HUMAN; HYDROCELE; IMMUNOGENICITY; INFANCY; INFANT; MALE; MEMBRANE VESICLE; MENINGOCOCCOSIS; MULTICENTER STUDY; NUCLEOTIDE SEQUENCE; OUTER MEMBRANE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PURPURA; RANDOMIZED CONTROLLED TRIAL; REACTIVE ARTHRITIS; VIRUS INFECTION; WHEEZING;

ADHESINS, BACTERIAL; ANTIBODIES, BACTERIAL; ANTIGENS, BACTERIAL; BACTERIAL OUTER MEMBRANE PROTEINS; CELL MEMBRANE; DRUG TOXICITY; FEMALE; GREAT BRITAIN; HUMANS; IMMUNIZATION SCHEDULE; INFANT; MALE; MENINGITIS, MENINGOCOCCAL; MENINGOCOCCAL VACCINES; NEISSERIA MENINGITIDIS, SEROGROUP B; SERUM BACTERICIDAL ANTIBODY ASSAY; VACCINES, SYNTHETIC;

EID: 78349257850     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/656741     Document Type: Article

References (28)

1. Granoff DM, Harrison LH, Borrow R. Meningococcal vaccines. In: Vaccines. Plotkin SA, Offit P, Orenstein WA, eds. Fifth ed. Philadelphia, PA: W. B. Saunders, 2008:399-434.
2. Wyle FA, Artenstein MS, Brandt BL, et al. Immunological response of man to group B meningococcal polysaccharide antigens. J Infect Dis 1972; 126:514-522.
3. Finne J, Leinonen M, Mäkelä PH. Antigenic similarities between brain components and bacteria causing meningitis. Implications for vaccine development and pathogenesis. Lancet 1983; 2:355-357.
4. Boslego J, Garcia J, Cruz C, et al; The Chilean national committee for meningococcal disease. Efficacy, safety, and immunogenicity of a meningococcal group B (15:P1.3) outer membrane protein vaccine in Iquique, Chile. Vaccine 1995; 13:821-829.
5. Fredriksen JH, Rosenqvist E, Wedege E, et al. Production, characterization and control of MenB-vaccine "Folkehelsa": an outer membrane vesicle vaccine against group B meningococcal disease. NIPH Ann 1991; 14:67-80.
6. Holst J, Feiring B, Fuglesang JE, et al. Serum bactericidal activity correlates with the vaccine efficacy of outer membrane vesicle vaccines against Neisseria meningitidis serogroup B disease. Vaccine 2003; 21:734-737.
7. Sierra GVC, Campa HC, Varcarel NM, et al. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann 1991; 14:195-210.
8. Kelly C, Arnod R, Galloway Y, O'Hallahan J. A prospective study of the effectiveness of the New Zealand meningococcal B vaccine. Am J Epidemiol 2007; 166:817-823. (Pubitemid 47428901)
9. Tappero JW, Lagos R, Ballesteros AM, et al. Immunogenicity of 2 serogroup B outer-membrane protein meningococcal vaccines: a randomised controlled trial in Chile. JAMA 1999; 281:1520-1527.
10. Giuliani MM, Adu-Bobie J, Comanducci M, et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A 2006; 103:10834-10839.
11. Capecchi B, Adu-Bobie J, Di Marcello F, et al. Neisseria meningitidis NadA is a new invasin which promotes bacterial adhesion to and penetration into human epithelial cells. Mol Microbiol 2005; 55:687-698.
12. Bambini S, Muzzi A, Olcen P, Rappuoli R, Pizza M, Comanducci M. Distribution and genetic variability of three vaccine components in a panel of strains representative of the diversity of serogroup B meningococcus. Vaccine 2009; 27:2794-2803.
13. Comanducci M, Bambini S, Muzzi A, et al. Variability of the antigens of the Novartis investigational MenB vaccine: a US vs Europe comparison [abstract 0027]. In: Program and abstracts of the 10th Meeting of the European Meningococcal Disease Society, 17-19 June 2009 (Manchester, UK):40.
14. Borrow R. Advances in the MenB vaccine development. In: Program and abstracts of the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases, 13-17 May 2008 (Graz, Austria):8.
15. Findlow J, Holland A, Andrews N, et al. Comparison of phenotypically indistinguishable but geographical distinct Neisseria meningitidis group B isolates in a serum bactericidal antibody assay. Clin Vaccine Immunol 2007; 14:1451-1457.
16. Giuliani MM, Biolchi A, Serruto D, et al. Measuring antigen specific bactericidal responses to a multicomponent vaccine against serogroup B meningococcus. Vaccine 2010; 28(31):5023-5030.
17. Borrow R, Carlone GM, Rosenstein N, et al. Neisseria meningitidis group B correlates of protection and assay standardization-international meeting report Emory University, Atlanta, Georgia, United States, 16-17 March 2005. Vaccine 2006; 24:5093-5107.
18. Beernink PT, Welsch JA, Harrison LH, Leipus A, Kaplan SL, Granoff DM. Prevalence of factor H-binding protein variants and NadA among meningococcal group B isolates from the United States: implications for the development of a multicomponent group B vaccine. J Infect Dis 2007; 195:1472-1479. (Pubitemid 46717465)
19. Masignani V, Comanducci M, Giuliani MM, et al. Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870. J Exp Med 2003; 197:789-799.
20. Mascioni A, Novikova E, Bentley BE, et al. Determination of the domain and solution structure of rLP2086, a meningococcal vaccine candidate and human factor H binding protein. In: Program and abstracts from the 16th International Pathogenic Neisseria Conference, 7-12 September 2008 (Rotterdam, the Netherlands):77.
21. Commanducci M, Bambini S, Brunelli B, et al. NadA, a novel vaccine candidate of Neisseria meningitidis. J Exp Med 2002; 195:1445-1454.
22. Comanducci M, Bambini S, Caugant DA, et al. NadA diversity and carriage in Neisseria meningitidis. Infect Immun 2004; 72:4217-4223.
23. Welsch JA, Moe GR, Rossi R, Adu-Bobie J, Rappuoli R, Granoff DM. Antibody to genome-derived Neisserial antigen 2132, a Neisseria meningitidis candidate vaccine, confers protection against bacteremia in the absence of complement-mediated bactericidal activity. J Infect Dis 2003; 188:1730-1740.
24. Plested JS, Granoff DM. Vaccine induced Opsonophagocytic immunity to Neisseria meningitidis group B. Clin Vaccine Immunol 2008; 15:799-804.
25. Wong SH, Lennon DR, Jackson CM, et al. Immunogenicity and tolerability in infants of a New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine. Pediatr Infect Dis J 2009; 28:385-390.
26. Wedege E, Bolstad K, Aase A, et al. Functional and specific antibody responses in adult volunteers in New Zealand who were given one of two different meningococcal serogroup B outer membrane vesicle vaccines. Clin Vaccine Immunol 2007; 14:830-838.
27. Wong S, Lennon D, Jackson C, et al. New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine in children aged 16-24 months. Pediatr Infect Dis J 2007; 26:345-350. (Pubitemid 46596661)
28. Snape MD, Dawson T, Oster P, et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life. A randomized comparative trial. Pediatr Infect Dis J 2010 [Epub ahead of prin].