Skip to main content
Erschienen in: Pädiatrie & Pädologie 3/2014

01.12.2014 | Leitthema

Der neue Mehrfachkomponentenimpfstoff 4CMenB zum Schutz vor Erkrankungen durch Meningokokken der Serogruppe B

Teil 1: Klinische Daten zur Immunogenität

verfasst von: Prof. Dr. K.F.M. Zwiauer, M. Bröker, A. Banzhoff

Erschienen in: Pädiatrie & Pädologie | Sonderheft 3/2014

Einloggen, um Zugang zu erhalten

Zusammenfassung

Meningokokkenerkrankungen sind in Österreich, Deutschland und der Schweiz selten, können aber schwerwiegende Folgen haben. Verschiedene Polysaccharidkonjugatimpfstoffe zum Schutz vor Erkrankungen durch die Serogruppen A, C, W und Y sind verfügbar, bis vor Kurzem aber kein Impfstoff zum Schutz vor einer Erkrankung durch die Serogruppe B, die für etwa 70 % der Meningokokkenerkrankungen verantwortlich ist. Nunmehr ist der proteinbasierte Meningokokkenserogruppe-B-Impfstoff 4CMenB verfügbar, der in klinischen Studien ein akzeptables Verträglichkeits- und Sicherheitsprofil aufwies. Hiermit ergeben sich erweiterte Möglichkeiten, um Säuglinge, Kleinkinder, Jugendliche und Erwachsene vor Meningokokkenerkrankungen zu schützen. Für den neuen Impfstoff 4CMenB sind verschiedene Impfschemata entwickelt worden. Zudem wurde er bereits in den Österreichischen Impfplan integriert.
Literatur
1.
Zurück zum Zitat Knuf M (2010) Invasive Meningokokken-Infektionen. UNI-MED Verlag AG, Bremen Knuf M (2010) Invasive Meningokokken-Infektionen. UNI-MED Verlag AG, Bremen
2.
Zurück zum Zitat Micoli F, Adamo R, Proietti D et al (2013) Meningococcal X polysaccharide quantification by high-performance anion-exchange chromatography using synthetic N-acetylglucosamine-4-phosphate as standard. Anal Biochem 442:259–261 PubMedCrossRef Micoli F, Adamo R, Proietti D et al (2013) Meningococcal X polysaccharide quantification by high-performance anion-exchange chromatography using synthetic N-acetylglucosamine-4-phosphate as standard. Anal Biochem 442:259–261 PubMedCrossRef
3.
Zurück zum Zitat Zollinger WD, Poolman JT, Maiden MC (2011) Meningococcal serogroup B vaccines: will they live up to expectations? Expert Rev Vaccines 10:559–561 PubMedCentralPubMedCrossRef Zollinger WD, Poolman JT, Maiden MC (2011) Meningococcal serogroup B vaccines: will they live up to expectations? Expert Rev Vaccines 10:559–561 PubMedCentralPubMedCrossRef
5.
Zurück zum Zitat Österreichische Agentur für Gesundheit und Ernährungssicherheit. http://​www.​ages.​at/​uploads/​media/​jahresbericht_​meningokokken_​2013_​final_​kommentar.​pdf Österreichische Agentur für Gesundheit und Ernährungssicherheit. http://​www.​ages.​at/​uploads/​media/​jahresbericht_​meningokokken_​2013_​final_​kommentar.​pdf
6.
Zurück zum Zitat Nationales Referenzzentrum für Meningokokken am Institut für Hygiene und Mikrobiologie der Universität Würzburg. http://​www.​meningococcus.​uni-wuerzburg.​de/​startseite/​berichte/​daten_​2013/​ Nationales Referenzzentrum für Meningokokken am Institut für Hygiene und Mikrobiologie der Universität Würzburg. http://​www.​meningococcus.​uni-wuerzburg.​de/​startseite/​berichte/​daten_​2013/​
7.
Zurück zum Zitat Schweizerische Eidgenossenschaft, Bundesamt für Gesundheit. http://​www.​meningo.​ch/​pdf/​Rapport%20CNM%202012%20version%20finale.pdf Schweizerische Eidgenossenschaft, Bundesamt für Gesundheit. http://​www.​meningo.​ch/​pdf/​Rapport%20CNM%202012%20version%20finale.pdf
8.
Zurück zum Zitat Schweizerische Eidgenossenschaft, Bundesamt für Gesundheit. http://​www.​bag.​admin.​ch/​themen/​medizin/​00682/​00684/​01089/​index.​html?​lang=​it#sprungmarke0_3 Schweizerische Eidgenossenschaft, Bundesamt für Gesundheit. http://​www.​bag.​admin.​ch/​themen/​medizin/​00682/​00684/​01089/​index.​html?​lang=​it#sprungmarke0_3
9.
Zurück zum Zitat Robert Koch Institut (2013) Zur Situation bei ausgewählten Infektionskrankheiten in Deutschland. Invasive Meningokokken-Erkrankungen, 2009–2011. Epidemiol Bull 39:389–397 Robert Koch Institut (2013) Zur Situation bei ausgewählten Infektionskrankheiten in Deutschland. Invasive Meningokokken-Erkrankungen, 2009–2011. Epidemiol Bull 39:389–397
10.
11.
Zurück zum Zitat Pizza M, Scarlato V, Masignani V et al (2000) Identification of vaccine candidates against serogroup B meningococcus by whole-genome sequencing. Science 287:1816–1820 PubMedCrossRef Pizza M, Scarlato V, Masignani V et al (2000) Identification of vaccine candidates against serogroup B meningococcus by whole-genome sequencing. Science 287:1816–1820 PubMedCrossRef
12.
Zurück zum Zitat Tettelin H, Saunders NJ, Heidelberg J et al (2000) Complete genome sequence of Neisseria meningitidis serogroup B strain MC58. Science 287:1809–1815 PubMedCrossRef Tettelin H, Saunders NJ, Heidelberg J et al (2000) Complete genome sequence of Neisseria meningitidis serogroup B strain MC58. Science 287:1809–1815 PubMedCrossRef
13.
Zurück zum Zitat McGuiness BT, Clarke IN, Lambden PR et al (1991) Point mutation in meningococcal por A gene associated with increased endemic disease. Lancet 337:514–517 CrossRef McGuiness BT, Clarke IN, Lambden PR et al (1991) Point mutation in meningococcal por A gene associated with increased endemic disease. Lancet 337:514–517 CrossRef
14.
Zurück zum Zitat Holst J (2007) Strategies for development of universal vaccines against meningococcal serogroup B disease: the most promising options and the challenges evaluating them. Hum Vaccine 3:290–294 CrossRef Holst J (2007) Strategies for development of universal vaccines against meningococcal serogroup B disease: the most promising options and the challenges evaluating them. Hum Vaccine 3:290–294 CrossRef
15.
Zurück zum Zitat Giuliani MM, Adu-Bobie J, Comanducci M et al (2006) A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A 103:10834–10839 CrossRef Giuliani MM, Adu-Bobie J, Comanducci M et al (2006) A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A 103:10834–10839 CrossRef
16.
Zurück zum Zitat Wassil J, McIntosh EDG, Serruto D et al (2012) The early clinical development of a multicomponent vaccine against meningococcal serogroup B. Clin Invest 2:503–517 CrossRef Wassil J, McIntosh EDG, Serruto D et al (2012) The early clinical development of a multicomponent vaccine against meningococcal serogroup B. Clin Invest 2:503–517 CrossRef
17.
Zurück zum Zitat Frasch CE, Borrow R, Donnelly J (2009) Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease. Vaccine 27(Suppl 2):B112–B116 PubMedCrossRef Frasch CE, Borrow R, Donnelly J (2009) Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease. Vaccine 27(Suppl 2):B112–B116 PubMedCrossRef
18.
Zurück zum Zitat Goldschneider I, Gotschlich EC, Artenstein MS (1969) Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 129:1307–1326 Goldschneider I, Gotschlich EC, Artenstein MS (1969) Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 129:1307–1326
19.
Zurück zum Zitat Goldschneider I, Gotschlich EC, Artenstein MS (1969) Human immunity to the meningococcus. II. Development of natural immunity. J Exp Med 129:1327–1348 Goldschneider I, Gotschlich EC, Artenstein MS (1969) Human immunity to the meningococcus. II. Development of natural immunity. J Exp Med 129:1327–1348
20.
Zurück zum Zitat Borrow R, Carlone GM, Rosenstein N et al (2006) Neisseria meningitidis group B correlates of protection and assay standardization—international meeting report Emory University, Atlanta, Georgia, United States, 16–17 March 2005. Vaccine 24:5093–5107 PubMedCrossRef Borrow R, Carlone GM, Rosenstein N et al (2006) Neisseria meningitidis group B correlates of protection and assay standardization—international meeting report Emory University, Atlanta, Georgia, United States, 16–17 March 2005. Vaccine 24:5093–5107 PubMedCrossRef
21.
Zurück zum Zitat Snape MD, Dawson T, Oster P et al (2010) Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J 29:e71–e79 Snape MD, Dawson T, Oster P et al (2010) Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J 29:e71–e79
22.
Zurück zum Zitat Findlow J, Borrow R, Snape MD et al (2010) 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 51:1127–1137 PubMedCrossRef Findlow J, Borrow R, Snape MD et al (2010) 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 51:1127–1137 PubMedCrossRef
23.
Zurück zum Zitat Toneatto D, Ismaili S, Ypma E et al (2011) The first use of an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) in humans. Hum Vaccin 7:646–653 PubMedCrossRef Toneatto D, Ismaili S, Ypma E et al (2011) The first use of an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) in humans. Hum Vaccin 7:646–653 PubMedCrossRef
24.
Zurück zum Zitat Kimura A, Toneatto D, Kleinschmidt A et al (2011) Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 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 18:483–486 PubMedCentralPubMedCrossRef Kimura A, Toneatto D, Kleinschmidt A et al (2011) Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 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 18:483–486 PubMedCentralPubMedCrossRef
25.
Zurück zum Zitat Snape MD, Saroey P, John TM et al (2013) Persistence of bacterial antibodies following early infant vacination with serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. Can Med Assoc J 185:E715–E724 CrossRef Snape MD, Saroey P, John TM et al (2013) Persistence of bacterial antibodies following early infant vacination with serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. Can Med Assoc J 185:E715–E724 CrossRef
26.
Zurück zum Zitat Snape MD, Philip J, John TM et al (2013) Bacterial 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 32:1116–1121 CrossRef Snape MD, Philip J, John TM et al (2013) Bacterial 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 32:1116–1121 CrossRef
27.
Zurück zum Zitat Gossger N, Snape MD, Yu LM et al (2012) Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA 307:573–582 PubMedCrossRef Gossger N, Snape MD, Yu LM et al (2012) Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA 307:573–582 PubMedCrossRef
28.
Zurück zum Zitat Vesikari T, Esposito S, Prymula R et al (2013) 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 381:86 Vesikari T, Esposito S, Prymula R et al (2013) 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 381:86
29.
Zurück zum Zitat Dull P, Banzhoff A, Toneatto D (2013) Concomitant administration of meningococcal serogroup B vaccine with routine infant vaccines including rotavirus vaccines. 8th World Congress of the World Society for Pedriatric Infectious Diseases. Cape Town, Südafrika, 19.–22. November 2013, Poster Dull P, Banzhoff A, Toneatto D (2013) Concomitant administration of meningococcal serogroup B vaccine with routine infant vaccines including rotavirus vaccines. 8th World Congress of the World Society for Pedriatric Infectious Diseases. Cape Town, Südafrika, 19.–22. November 2013, Poster
30.
Zurück zum Zitat Santolaya ME, O’Ryan ML, Valenzuela MT et al (2012) 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. Lancet 379:617–624 PubMedCrossRef Santolaya ME, O’Ryan ML, Valenzuela MT et al (2012) 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. Lancet 379:617–624 PubMedCrossRef
31.
Zurück zum Zitat Santolaya ME, O’Ryan ML, Valenzuela MT et al (2013) Persistence of antibodies in adolescents 18–24 months after immunisation with one, two or three doses of 4CMenB meningococcal serogroup B vaccine. Hum Vacc Immunother 9:2304–2310 CrossRef Santolaya ME, O’Ryan ML, Valenzuela MT et al (2013) Persistence of antibodies in adolescents 18–24 months after immunisation with one, two or three doses of 4CMenB meningococcal serogroup B vaccine. Hum Vacc Immunother 9:2304–2310 CrossRef
32.
Zurück zum Zitat Vogel U, Taha MK, Vazquez JA et al (2013) Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis 13:416–4252 PubMedCrossRef Vogel U, Taha MK, Vazquez JA et al (2013) Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis 13:416–4252 PubMedCrossRef
33.
Zurück zum Zitat Boccadifuoco D et al (2011) Präsentiert auf: Meningitis and Septicaemia in Children and Adults 2011 (Meningitis Research Foundation), 8.–9. November 2011, London, Großbritannien. Poster V36 Boccadifuoco D et al (2011) Präsentiert auf: Meningitis and Septicaemia in Children and Adults 2011 (Meningitis Research Foundation), 8.–9. November 2011, London, Großbritannien. Poster V36
34.
Zurück zum Zitat Frosi G, Biolchi A, Lo Sapio M et al (2013) Serum bactericidal antibody against capsular group B meningococcal isolates responsible for invasive disease shows that MATS is a conservative predictor of strain coverage by the 4CMenB vaccine. Vaccine 31:4968–4974 PubMedCrossRef Frosi G, Biolchi A, Lo Sapio M et al (2013) Serum bactericidal antibody against capsular group B meningococcal isolates responsible for invasive disease shows that MATS is a conservative predictor of strain coverage by the 4CMenB vaccine. Vaccine 31:4968–4974 PubMedCrossRef
35.
Zurück zum Zitat Claus H, Borrow R, Taha M-K et al (2012) Potential coverage of the 4CMenB vaccine in non-B meningococci. XVIIIth International Pathogenic Neisseria Conference 2012, Poster 273 Claus H, Borrow R, Taha M-K et al (2012) Potential coverage of the 4CMenB vaccine in non-B meningococci. XVIIIth International Pathogenic Neisseria Conference 2012, Poster 273
36.
Zurück zum Zitat Read RC, Baxter D, Chadwick DR et al (2014) Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage. An observer-blind, phase 3 randomised clinical trial. Lancet. doi:org/10.1016/S0140-6736(14)60842-4 Read RC, Baxter D, Chadwick DR et al (2014) Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage. An observer-blind, phase 3 randomised clinical trial. Lancet. doi:org/10.1016/S0140-6736(14)60842-4
37.
Zurück zum Zitat O’Ryan M, Stoddard J, Toneatto D et al (2014) A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs 74:15–30 CrossRef O’Ryan M, Stoddard J, Toneatto D et al (2014) A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs 74:15–30 CrossRef
Metadaten
Titel
Der neue Mehrfachkomponentenimpfstoff 4CMenB zum Schutz vor Erkrankungen durch Meningokokken der Serogruppe B
Teil 1: Klinische Daten zur Immunogenität
verfasst von
Prof. Dr. K.F.M. Zwiauer
M. Bröker
A. Banzhoff
Publikationsdatum
01.12.2014
Verlag
Springer Vienna
Erschienen in
Pädiatrie & Pädologie / Ausgabe Sonderheft 3/2014
Print ISSN: 0030-9338
Elektronische ISSN: 1613-7558
DOI
https://doi.org/10.1007/s00608-014-0211-x