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

The Lancet

Volumn 379, Issue 9816, 2012, Pages 617-624

  Santolaya, María Elena ^a   O'Ryan, Miguel L ^a   Valenzuela, María Teresa ^b   Prado, Valeria ^a   Vergara, Rodrigo ^c   Muñoz, Alma ^d   Toneatto, Daniela ^e   Graña, Gabriela ^e   Wang, Huajun ^e   Clemens, Ralf ^e   Dull, Peter M ^e  

^a UNIVERSITY OF CHILE   (Chile)

^b UNIVERSIDAD DE LOS ANDES   (Chile)

^c UNIVERSIDAD DE VALPARAÍSO   (Chile)

^d Centro para Vacunas en Desarrollo Chile   (Chile)

^e NOVARTIS VACCINES AND DIAGNOSTICS   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN; ANTIPYRETIC AGENT; MENINGOCOCCUS VACCINE; MULTICOMPONENT MENINGOCOCCUS SEROGROUP B VACCINE; PLACEBO; UNCLASSIFIED DRUG;

ADOLESCENT; ANTIBODY TITER; ARTICLE; BACTERIAL STRAIN; CHILD; CHILE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INJECTION SITE REACTION; JUVENILE RHEUMATOID ARTHRITIS; MAJOR CLINICAL STUDY; MALAISE; MALE; NORMAL HUMAN; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SERUM BACTERICIDAL ACTIVITY; SINGLE BLIND PROCEDURE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

EID: 84857238470     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(11)61713-3     Document Type: Article

References (27)

1. LH Harrison, CL Trotter, ME Ramsay Global epidemiology of meningococcal disease Vaccine 27 suppl 3 2009 B51 B63
2. LK Tan, GM Carlone, R Borrow Advances in the development of vaccines against Neisseria meningitidis N Engl J Med 362 2010 1511 1520
3. DS Stephens Conquering the meningococcus FEMS Microbiol Rev 31 2007 3 14 (Pubitemid 46058815)
4. LA Jackson, R Baxter, K Reisinger et al. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents Clin Infect Dis 49 2009 e1 10
5. R Baxter, Y Baine, K Ensor, V Bianco, LR Friedland, JM Miller Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age Pediatr Infect Dis J 30 2011 e41 e48
6. VN Racloz, SL Luiz The elusive meningococcal meningitis serogroup: a systematic review of serogroup B epidemiology BMC Infect Dis 10 2010 175
7. European Union Invasive Bacterial Infections Surveillance Network Invasive Neisseria meningitidis in Europe 2006 http://www.hpa-bioinformatics. org.uk/euibis/documents/2006-meningo.pdf (accessed Dec 9, 2011).
8. Ministerio de Salud, Gobierno de Chile http://epi.minsal.cl/epi/html/ bolets/reportes/Meningitis/meningitis.pdf (accessed Dec 9, 2011).
9. FA Wyle, MS Artenstein, BL Brandt et al. Immunologic response of man to group B meninogococcal polysaccharide vaccines J Infect Dis 126 1972 514 521
10. J Finne, D Bitter-Suermann, C Goridis, U Finne An IgG monoclonal antibody to group B meningococci cross-reacts with developmentally regulated polysialic acid units of glycoproteins in neural and extraneural tissues J Immunol 138 1987 4402 4407 (Pubitemid 17090418)
11. J Nedelec, J Boucraut, JM Garnier, D Bernard, G Rougon Evidence for autoimmune antibodies directed against embryonic neural cell adhesion molecules (N-CAM) in patients with group B meningitis J Neuroimmunol 29 1990 49 56 (Pubitemid 20283781)
12. M Sadarangani, AJ Pollard Serogroup B meningococcal vaccines - an unfinished story Lancet Infect Dis 10 2010 112 124
13. DM Granoff Review of meningococcal group B vaccines Clin Infect Dis 50 suppl 2 2010 S54 S65
14. M Pizza, V Scarlato, V Masignami et al. Identification of vaccine candidates against ssrogroup B meningococcus by whole-genome sequencing Science 287 2000 1816 1820
15. MM Giuliani, J Adu-Bobie, M Comanducci et al. A universal vaccine for serogroup B meningococcus PNAS 103 2006 10834 10839 (Pubitemid 44148381)
16. D Serruto, T Spadafina, L Ciuccui et al. Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans PNAS 107 2010 3770 3775
17. MD Snape, T Dawson, P Oster et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial Pediatr Infect Dis J 29 2010 e71 e79
18. J Findlow, R Borrow, MD Snape et al. Multicentre, open-label, randomised phase II controlled study of an investigational recombinant serogroup B vaccine with and without outer membrane vesicles, administered in infancy Clin Infect Dis 51 2010 1127 1137
19. 197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates Clin Vaccine Immunol 18 2011 483 486
20. MM Giuliani, A Biolchi, D Serruto et al. Measuring antigen-specific bactericidal responses to a multicomponent vaccine against serogroup B meningococcus Vaccine 28 2010 5023 5030
21. CE Frasch, R Borrow, J Donnelly Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease Vaccine 27 suppl 2 2009 B112 B116
22. J Donnelly, D Medini, G Boccadifuoco et al. Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines PNAS 107 2010 19490 19495
23. Donnelly J, Medini D, Giuliani M, et al. Estimating the potential strain coverage in Europe of a multicomponent vaccine targeting serogroup B meningococci. 11th EMGM conference, Ljubljana, Slovenia; May 18-20, 2011. Abstract O 08.
24. PT Beernick, DA Caugent, JA Welsch, O Koeberling, DM Granoff Meningococcal factor H-binding protein variants expressed by epidemic capsular group A, W-135, and X strains from Africa J Infect Dis 199 2009 1360 1368
25. P Boisier, P Nicolas, S Djibo et al. Meningococcal meningitis: unprecedented incidence of serogroup X-related cases in 2006 in Niger Clin Infect Dis 44 2007 657 663
26. HQ Jiang, SK Hoiseth, SL Harris et al. Broad vaccine coverage predicted for a bivalent recombinant factor H binding protein based vaccine to prevent serogroup B meningococcal disease Vaccine 28 2010 6086 6093
27. A McNicholas, Y Galloway, P Stehr-Green et al. Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006 Hum Vacc 3 2007 196 204 (Pubitemid 47603111)