A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II): Effects of variations of the OMV and protein content on immunogenicity and reactogenicity

Human Vaccines and Immunotherapeutics

Volumn 10, Issue 7, 2014, Pages 2005-2014

  Esposito, Susanna ^a   Prymula, Roman ^b,c   Zuccotti, Gian Vincenzo ^a   Xie, Fang ^d   Barone, Michelangelo ^d   Dull, Peter M ^d   Toneatto, Daniela ^d  

^a UNIVERSITY OF MILAN   (Italy)

^b UNIVERSITY HOSPITAL HRADEC KRALOVE   (Czech Republic)

^c CHARLES UNIVERSITY   (Czech Republic)

^d NOVARTIS VACCINES AND DIAGNOSTICS   (United States)

Author keywords

Infants; Meningococcal; Outer membrane vesicles; Serogroup B; Vaccination

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B HEPATITIS B VACCINE; MEMBRANE PROTEIN; MENINGOCOCCUS VACCINE; PNEUMOCOCCUS VACCINE; RECOMBINANT MEMBRANE PROTEIN; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG; 4CMENB VACCINE; BACTERIAL ANTIGEN;

ANTIBODY TITER; ARTICLE; BACTERIAL OUTER MEMBRANE; BEHAVIOR DISORDER; CONTROLLED STUDY; CRYING; DRUG SAFETY; DRUG TOLERABILITY; EATING HABIT; ERYTHEMA; FEMALE; FEVER; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INFANT; INJECTION SITE REACTION; IRRITABILITY; MALE; MULTICENTER STUDY; OUTER MEMBRANE VESICLE; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; SERUM BACTERICIDAL ACTIVITY; SOMNOLENCE; VOMITING; CLINICAL TRIAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; IMMUNOLOGY; NEISSERIA MENINGITIDIS; PATHOLOGY;

ANTIGENS, BACTERIAL; BLOOD BACTERICIDAL ACTIVITY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; INFANT; MALE; MENINGOCOCCAL VACCINES; NEISSERIA MENINGITIDIS, SEROGROUP B;

EID: 84908360364     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.29218     Document Type: Article

References (17)

1. Finne J, Leinonen M, Mäkelä PH. Antigenic similarities between brain components and bacteria causing meningitis. Implications for vaccine development and pathogenesis. Lancet 1983; 2:355-7; PMID:6135869; http://dx.doi.org/10.1016/S0140-6736(83)90340-9
2. Finne J, Bitter-Suermann D, Goridis C, Finne U. 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 1987; 138:4402-7; PMID:3108388
3. Findlow J, Borrow R, Snape MD, Dawson T, Holland A, John TM, Evans A, Telford KL, Ypma E, Toneatto D, et al. 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. Clin Infect Dis 2010; 51:1127-37; PMID:20954968; http://dx.doi.org/10.1086/656741
4. Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, Findlow J, Yu LM, Borrow R, Ypma E, 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; 29:e71-9; PMID:20844462
5. Gossger N, Snape MD, Yu L-M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, et al. European MenB Vaccine Study Group. Immunogenicity and tolerability of recombinant meningococcal serogroup B vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA 2012; 307:573-82; PMID:22318278; http://dx.doi.org/10.1001/jama.2012.85
6. Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet 2013; 381:825-35; PMID:23324563; http://dx.doi.org/10.1016/S0140-6736(12)61961-8
7. Holst J, Oster P, Arnold R, Tatley MV, Næss LM, Aaberge IS, Galloway Y, McNicholas A, O'Hallahan J, Rosenqvist E, et al. Vaccines against meningococcal serogroup B disease containing outer membrane vesicles (OMV): lessons from past programs and implications for the future. Hum Vaccin Immunother 2013; 9:1241-53; PMID:23857274; http://dx.doi.org/10.4161/hv.24129
8. Bjune G, Høiby EA, Grønnesby JK, Arnesen O, Fredriksen JH, Halstensen A, Holten E, Lindbak AK, Nøkleby H, Rosenqvist E, et al. Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway. Lancet 1991; 338:1093-6; PMID:1682541; http://dx.doi.org/10.1016/0140-6736(91)91961-S
9. O'Hallahan J, McNicholas A, Galloway Y, O'Leary E, Roseveare C. Delivering a safe and effective strain-specific vaccine to control an epidemic of group B meningococcal disease. N Z Med J 2009; 122:48-59; PMID:19322255
10. Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine development. Vaccine 2001; 19:2688-91; PMID:11257410; http://dx.doi.org/10.1016/S0264-410X(00)00554-5
11. Prymula R, Esposito S, Zuccotti GV, Kittel C, Toneatto D, Kohl I, Dull P. A phase 2 randomised controlled trial of a multicomponent meningococcal serogroup B vaccine (I): effects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB. Hum Vacc Immuntherapeut., Submitted.
12. Frasch CE, Borrow R, Donnelly J. Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease. Vaccine 2009; 27(Suppl 2):B112-6; PMID:19464093; http://dx.doi.org/10.1016/j.vaccine.2009.04.065
13. Donnelly J, Medini D, Boccadifuoco G, Biolchi A, Ward J, Frasch C, Moxon ER, Stella M, Comanducci M, Bambini S, et al. Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines. Proc Natl Acad Sci U S A 2010; 107:19490-5; PMID:20962280; http://dx.doi.org/10.1073/pnas.1013758107
14. Lucidarme J, Newbold LS, Findlow J, Gilchrist S, Gray SJ, Carr AD, Hewitt J, Kaczmarski EB, Borrow R. Molecular targets in meningococci: efficient routine characterization and optimal outbreak investigation in conjunction with routine surveillance of the meningococcal group B vaccine candidate, fHBP. Clin Vaccine Immunol 2011; 18:194-202; PMID:21123522; http://dx.doi.org/10.1128/CVI.00401-10
15. Vogel U, Taha MK, Vazquez JA, Findlow J, Claus H, Stefanelli P, Caugant DA, Kriz P, Abad R, Bambini S, et al. Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis 2013; 13:416-25; PMID:23414709; http://dx.doi.org/10.1016/S1473-3099(13)70006-9
16. Snape MD, Saroey P, John TM, Robinson H, Kelly S, Gossger N, Yu L-M, Wang H, Toneatto D, Dull PM, et al. Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. CMAJ 2013; 185:E715-24; PMID:24062178; http://dx.doi.org/10.1503/cmaj.130257
17. Snape MD, Philip J, John TM, Robinson H, Kelly S, Gossger N, Yu L-M, Kittel C, Toneatto D, Dull PM, et al. Bactericidal antibody persistence 2 years after immunization with 2 investigational serogroup B meningococcal vaccines at 6, 8 and 12 months and immunogenicity of preschool booster doses: a follow-on study to a randomized clinical trial. Pediatr Infect Dis J 2013; 32:1116-21; PMID:23958808; http://dx.doi.org/10.1097/INF.0b013e31829cfff2