medigraphic.com
ISSN 1527-3172 (Electronic)

2019, Number 4

<< Back Next >>

MEDICC Review 2019; 21 (4)

Cuban meningococcal vaccine va-mengoc-bc: 30 years of use and future potential

Sierra-González, VG

Language: English
References: 71
Page: 19-27
PDF size: 177.65 Kb.


ABSTRACT

Every year, meningococcal infection by Neisseria meningitidis causes over 500,000 cases and 85,000 deaths in the world, with 20% of survivors suffering sequelae. In Cuba its incidence in 1980 reached 5.9 cases per 100,000 population; about 80% of cases were serogroup B, prompting health authorities to declare meningococcal disease the country’s main public health problem.
Several provinces reported over 120 cases per 100,000 children aged <1 year, overwhelmingly serogroup B. At that time, no vaccines existed with proven efficacy against N. meningitidis serogroup B, nor was there a vaccine candidate that could be successful in the short term. By 1989, researchers in Havana had developed a Cuban meningococcal B and C vaccine, VA-MENGOC-BC, the world’s first against serogroup B meningococcal disease. Its efficacy of 83% was demonstrated in a prospective, randomized, double-blind, placebo-controlled field study. Vaccine production used vesicle or proteoliposome technology for the first time. The same year, the World Intellectual Property Organization awarded its gold medal to the main authors of the VA-MENGOC-BC patent.
The vaccine was used in a mass vaccination campaign and later included in Cuba’s National Immunization Program, with a cumulative impact on incidence of serogroup B meningococcal disease greater than 95% (93%–98%). Mass, systematic vaccination shifted the spectrum of meningococcal strains in healthy asymptomatic carriers and strains circulating among population groups toward nonvirulent phenotypes. The disease ceased to be a public health problem in the country. VA-MENGOC-BC is the most widely applied vaccine against serogroup B meningococcal disease in the world. Over 60 million doses have been administered in Latin America. In several countries where it has been applied, in which strains other than the vaccine-targeted strains circulate, VA–MENGOC–BC has demonstrated effectiveness against all (55%–98% in children aged ≤4 years and 73%–100% in children aged >4 years). The vaccine and its proteoliposome technology have had an impact and continue to have potential, not only for meningococcal disease, but also for development of other vaccines and adjuvants.


REFERENCES

  1. Vieusseux M. Memoire sur la maladie qui a régné à Genève au printemps de 1805. J Med Clin Pharm. 1805;11:163–82. French.

  2. Weichselbaum A. Ueber die aetiologie der akuten meningitis cerebro-spinal. Fortschr Med. 1887;5:573–83, 620–63. German.

  3. Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. Vaccine. 2009 Jun 24;27 Suppl 2:B51–63.

  4. Nadel S, Ninis N. Invasive meningococcal disease in the vaccine era. Front Pediatr. 2018 Nov 9;6:321.

  5. Lukši I, Muli R, Falconer R, Orban M, Sidhu S, Rudan I. Estimating global and regional morbidity from acute bacterial meningitis in children. Croat Med J. 2013 Dec;54(6):510–8.

  6. Edmond K, Clark A, Korczak VS, Sanderson C, Grif ths UK, Rudan I. Global and regional risk of disabling sequelae from bacterial meningitis: a systematic review and meta-analysis. Lancet Infect Dis. 2010 May;10(5):317–28.

  7. Caugant DA, Maiden MC. Meningococcal carriage and disease–population biology and evolution. Vaccine. 2009 Jun 24;27 Suppl 2:B64–70.

  8. Valcárcel M, Rodríguez R, Terry H. La Enfermedad Meningocócica en Cuba: Cronología de una Epidemia. Havana: Editorial de Ciencias Médicas; 1991. Spanish.

  9. Zollinger WD, Mandrell RE, Altieri P, Berman S, Lowenthal J, Artenstein MS. Safety and immunogenicity of a Neisseria meningitidis type 2 protein vaccine in animals and humans. J Infect Dis. 1978 Jun;137(6):728–39.

  10. Helting TB, Guthöhrlein G, Blackkolb F, Ronneberger H. Serotype determinant protein of Neisseria meningitidis. Large scale preparation by direct detergent treatment of the bacterial cells. Acta Pathol Microbiol Scand C. 1981 Apr;89(2):69–78.

  11. Frasch CE, Peppler MS. Protection against group B Neisseria meningitidis disease: preparation of soluble protein and protein-polysaccharide immunogens. Infect Immun. 1982 Jul;37(1):271– 80.

  12. Frøholm LO, Berdal BP, Bøvre K, Gaustad P, Harboe A, Holten E, et al. Meningococcal group B vaccine trial in Norway. Preliminary report of results available November1983. NIPH Ann [Internet]. 1983 Dec [cited 2019 Jan 8];6(2):133–8. Available from: https://www.researchgate.net/ scienti c-contributions/61802708

  13. Campa C, Sierra VG, Gutiérrez MM, Bisset G, García L, Puentes G, et al. Método para la obtención de una vacuna de amplio espectro protector contra Neisseria meninigitidis del serogrupo B y la vacuna resultante. Patente Cubana CU 21888 A1. Havana: Finlay Institute; 1989. Spanish.

  14. Campa C, Sierra VG, Gutiérrez MM, Bisset G, García L, Puentes G, et al. Method for obtaining a vaccine with wide protective range against group B Neisseria meningitidis, the resulting vaccine, gammaglobulin and transfer factor. European Patent EP 0301992; 1995. Available from: https://patentimages.storage. googleapis.com/2a/67/0a/86991ddd224929/ EP0301992A2.pdf

  15. Masforrol Y, Gil J, García D, Noda J, Ramos Y, Betancourt L, et al. A deeper mining on the protein composition of VA-MENGOCBC®: An OMVbased vaccine against N. meningitidis serogroup B and C. Hum Vaccin Immunother [Internet]. 2017 Nov 2 [cited 2019 Jan 8];13(11):2548–60. Available from: https://www.tandfonline.com/doi/ pdf/10.1080/21645515.2017.1356961

  16. Sierra GV, Campa HC, Varcacel NM, García IL, Izquierdo PL, Sotolongo PF, et al. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann. 1991 Dec;14(2):195–207.

  17. Tamargo B, Ramírez W, Márquez Y, Cedré B, Fresno M, Sierra G. New proteoliposomic formulation from N. meningitidis serogroup B, without aluminum hydroxide, retains its antimeningococcal protectogenic potencial as well as Th-1 adjuvant capacity. BMC Immunology [Internet]. 2013 Feb 25 [cited 2019 Jan 8];14(Suppl 1):S12. Available from: http://www.biomedcentral.com/1471 -2172/14/S1/S12

  18. Center for State Control of Medicines, Equipment and Medical Devices (CECMED). VAMENGOCBC ®. Vacuna antimeningocócica BC. Titular del Registro Sanitario, país: Instituto Finlay de Vacunas. Cuba. Fecha de Inscripción: 22 de octubre de 1987. Havana: Center for State Control of Medicines, Equipment and Medical Devices (CECMED) [Internet]. 1987 [cited 2019 May 2]. 4 p. Available from: http://www.cecmed .cu/sites/default/files/adjuntos/rcp/biologicos/ rcp_va_mengoc_bc_2016_formato_cecmed _rev_rold_20161025.pdf. Spanish.

  19. Tamargo Santos B, Fleitas Pérez C, Infante Bourzac JF, Márquez Nápoles Y, Ramírez González W, Bourg V, et al. Remote induction of cellular immune response in mice by anti-meningococcal nanocochleatesnanoproteoliposomes. Sci Total Environ [Internet]. 2019 Jun 10 [cited 2019 Aug 10];668:1055–63. Available from: https://doi. org/10.1016/j.scitotenv.2019.03.075

  20. Tamargo SB, Bungau S, Fleitas Pérez C, Márquez Nápoles Y, Infante Bourzac JF, Oliva Hernández R, et al. Immuno-toxicological Evaluation of the adjuvant formulations for experimental antimeningococcal vaccines without aluminium hydroxide. Rev Chimie (Bucharest). [Internet]. 2019 Apr;70(4):1251–7. Available from: http://www .revistadechimie.ro

  21. Pérez Rodríguez A, Dickinson F, Tamargo I, Sosa J, Quintana I, Ortiz P, et al. Resultados y experiencias de la vigilancia nacional de meningitis bacteriana en Cuba. Biotecnolo Aplic. 2003;20 (2):118–22. Spanish.

  22. Sotolongo Padrón F, Campa Huergo C, Casanueva Gil V, Fajardo Díaz EM, Cuevas Valdespino IE, González Gotera N. Cuban Meningococcal BC vaccine: experiences and contributions from 20 years of application. MEDICC Rev. 2007 Oct;9(1):16–22.

  23. Rodríguez M, Pérez A, Llanes R, Dickinson F, Cuevas, IE, Pérez K. Características epidemiológicas y microbiológicas en casos con rmados de enfermedad meningocócica en Cuba, 1998– 2007. VacciMonitor. 2013;22(2):1–8. Spanish.

  24. Martínez Motas I, Sierra González G, Núñez Gutiérrez N, Izquierdo Pérez L, Climent Ruíz Y, Mirabal Sosa M. Caracterización de cepas de Neisseria meningitidis aisladas de portadores en Cuba durante 20 años. Rev Cubana Med Trop. 2006 May–Aug;58(2):124–33. Spanish.

  25. Climent Y, Yero D, Martínez I, Martín A, Jolley KA, Sotolongo F, et al. Clonal distribution of disease- associated and healthy carrier isolates of Neisseria meningitidis between 1983 and 2005 in Cuba. J Clin Microbiol. 2010 Mar;48(3):802–10.

  26. Law DK, Lorange M, Ringuette L, Dion R, Giguère M, Henderson AM, et al. Invasive meningococcal disease in Quebec, Canada, due to an emerging clone of ST-269 serogroup B meningococci with serotype antigen 17 and serosubtype antigen P1.19 (B:17:P1.19). J Clin Microbiol. 2006 Aug;44(8):2743–9.

  27. Pérez Rodríguez A, Dickinson Meneses F, Rodríguez Ortega M. Efectividad de la vacuna antimeningocócica VA-MENGOC-BC® en el primer año de vida, Cuba, 1997–2008. Rev Cubana Med Trop. 2011 May–Aug;63(2):155–60. Spanish.

  28. Tappero JW, Lagos R, Ballesteros AM, Plikaytis B, Williams D, Dykes J, et al. Immunogenicity of 2 serogroup B outer-membrane protein meningococcal vaccines. A randomized controlled trial in Chile. JAMA. 1999 Apr 28;281(16):1520–7.

  29. Perkins BA, Jonsdottir K, Briem H, Grif ths E, Plikaytis BD, Hoiby EA, et al. Immunogenicity of two ef-  cacious outer membrane protein-based serogroup B meningococcal vaccines among young adults in Iceland. J Infect Dis. 1998 Mar;177(3):683–91.

  30. Boutriau D, Poolman J, Borrow JR, Findlow J, Diez J, Puig-Barbera J, et al. Immunogenicity and safety of three doses of a bivalent meningococcal outer membrane vesicle vaccine in healthy adolescents. Clin Vaccine Immunol. 2007 Jan;14(1):65–73.

  31. Galguera Domínguez M, Sierra González G, Martínez Torres E, Campa Huergo C, Almeida González L, Le Riverend Morales L, et al. Utilización terapéutica de gamma globulina hiperinmune especí ca en la enfermedad meningocócica del niño. Rev Cubana Pediatr. 1991 Jan–Apr;63(1):55–62. Spanish.

  32. Balboa GJA. Inmunoglobulina humana antimeningococcica: obtención, caracterización y capacidad protectora [thesis]. [Havana]: Finlay Institute; 2006. Spanish.

  33. Camero Santiesteban AA, Balboa González JA, Nerey Olivares MC, Malberty Agüero JA, Paradoa Pérez M, Joó Sánchez L, et al. Composición de inmunoglobulinas en la inmunoglobulina humana antimeningocócica. Rev Cubana Farm [Internet]. 1998 Sep–Dec [cited 2019 May 19];32(3):151–6. Available from: http://scielo .sld.cu/scielo.php?script=sci_arttext&pid=S0034 -75151998000300001&lng=es. Spanish.

  34. Wi T, Lahra MM, Ndowa F, Bala M, Dillon JR, Ramón-Pardo P, et al. Antimicrobial resistance in Neisseria gonorrhoeae: global surveillance and a call for international collaborative action. PLoS Med. 2017 Jul 7;14(7):e1002344.

  35. Petousis-Harris H. Impact of meningococcal group B OMV vaccines, beyond their brief. Hum Vaccin Immunother [Internet]. 2018 May 4 [cited 2019 Jan 8];14(5):1058–63. Available from: https://doi.org/10.1080/21645515.2017.1381810

  36. Pérez O, del Campo J, Cuello M, González E, Nuñez N, Cabrera O, et al. Mucosal approaches in Neisseria vaccinology. VacciMonitor. 2009 Jan;18:53–5.

  37. Petousis-Harris H, Paynter J, Morgan J, Saxton P, McArdle B, Goodyear-Smith F, et al. Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study. Lancet. 2017 Sep 30;390(10102):1603–10.

  38. Paynter J, Goodyear-Smith F, Morgan J, Saxton P, Black S, Petousis-Harris H. Effectiveness of a Group B outer membrane vesicle meningococcal vaccine in preventing hospitalization from gonorrhea in New Zealand: a retrospective cohort study. Vaccines (Basel). 2019 Jan 5;7(1). pii: E5.

  39. Sierra González G, Tamargo Santos B. Adyuvantes inmunológicos para vacunas humanas; estado actual, tendencias mundiales y en Cuba. Rev Anales Acad Cienc Cuba. 2011;1(2):1–32. Spanish.

  40. Pérez Martín OG, Bracho Grando GR, Lastre González M, Sierra González VG, Campa Huergo C, Mora González N, et al. Method of obtaining cochlear structures, vaccine compositions, adjuvants and inter mediates thereof. WO 2004/047805 Al [Internet]. Geneva: World Intellectual Property Organization; 2005 Sep 12 [cited 2019 Jan 8]. 3 p. Available from: https://www.re searchgate.net/publication/332263277. Spanish.

  41. Lastre González M, Pérez Martín O, Labrada Rosado A, Bidot Martínez I, Pérez Lastre J, Bracho Granada G, et al. Allergy vaccine composition, production method thereof and use of same in allergy treatment [Internet]. Geneva: World Intellectaul Property Organization; 2003 Nov 20 [cited 2019 Jan 8]. Available from: https://patentscope.wipo.int/search/en/detail .jsf?docId=WO2003094964

  42. Pérez Martín O, González Aznar E, Romeu Álvarez B, Del Campo Alonso J, Acevedo Grogues R, Lastre González M, et al. Single-time vaccines. WO 2010 057447 A1 [Internet]. California: Google Patents; 2010 [cited 2019 Jan 8]. Available from: https://patents.google.com/patent/ WO2010057447A1/. Spanish.

  43. Pérez Martín O, Pérez Cuello M, Cabrera Blanco O, Balboa González JA, Lastre González M, González Zayas V, et al. Adjuvanted tolerogens as a malaria vaccine. WO2011137876A2 [Internet]. California: Google Patents; 2011 [cited 2019 Jan 8]. Available from: https://patents.google .com/patent/WO2011137876A2/. Spanish.

  44. Fernández Molina LE, Sánchez Ramírez B, Suárez Pestana ER, De La Barrera Aira A, Mesa Pardillo C, De León Delgado J, et al. Pharmaceutical compositions enhancing the immunogenicity of poorly immunogenic antigens. WO2002045746A2 [Internet]. California: Google Patents; 2011 [cited 2019 Jan 8]. Available from: https://patents.google.com/patent/ WO2002045746A2/. Spanish.

  45. Estévez F, Carr A, Solorzano L, Valiente O, Mesa C, Barroso O, et al. Enhancement of the immune response to poorly immunogenic gangliosides after incorporation into very small size proteoliposomes (VSSP). Vaccine. 1999 Aug 20;18(1–2):190–7.

  46. Tamargo B, Rosario LA, Batista N, Arencibia DF, Fernández K, Villegas A, et al. Protección inducida por nanococleatos derivados de proteoliposomasde Leptospira interrogans serovar Canicola. VacciMonitor. 2012;21(1):3–9. Spanish.

  47. Acevedo R, Callicó A, del Campo J, González E, Cedré B, González L, et al. Intranasal administration of proteoliposome-derived cochleates from Vibrio cholerae O1 induce mucosal and systemic immune responses in mice. Methods 2009 Dec;49(4):309–15.

  48. Fernández S, Fajardo EM, Mandiarote A, Año G, Padrón MA, Acosta M, et al. A proteoliposome formulation derived from Bordetella pertussis induces protection in two murine challenge models. BMC Immunol. 2013;14 Suppl 1:S8.

  49. Pajón R, Chinea G, Marrero E, González D, Guillén G. Sequence analysis of the structural tbpA gene: protein topology and variable regions within neisserial receptors for transferrin iron acquisition. Microb Pathog [Internet]. 1997 Aug [cited 2018 Oct 15];23(2):71–84. Available from: https://doi.org/10.1006/mpat.1997.0136

  50. Delgado M, Yero D, Niebla O, Sardiñas G, González S, Caballero E, et al. Analysis of the genetic variability and immunological properties of the NlpB antigen, a novel protein identi ed in Neisseria meningitidis. Biotecnol Aplic. 2009 Jan–Mar;26(1):85–7.

  51. Menéndez T, Santiago-Vispo NF, Cruz-Leal Y, Coizeau E, Garay H, Reyes O, et al. Identi cation and characterization of phage-displayed peptide mimetics of Neisseria meningitidis serogroup B capsular polysaccharide. Int J Med Microbiol. 2011 Jan;301(1):16–25.

  52. Uli L, Castellanos Serra L, Betancourt L, Domínguez F, Barberá R, Sotolongo F, et al. Outer membrane vesicles of the VA-MENGOC-BC® vaccine against serogroup B of Neisseria meningitidis: Analysis of protein components by two-dimensional gel electrophoresis and mass spectrometry. Proteomics. 2006 Jun;6(11):3389–99.

  53. Gil J, Betancourt LZ, Sardiñas G, Yero D, Niebla O, Delgado M, et al. Proteomic study via a non-gel based approach of meningococcal outer membrane vesicle vaccine obtained from strain CU385: a road map for discovering new antigens. Hum Vaccin. 2009 May;5(5):347–56.

  54. Center for State Control of Medicines, Equipment and Medical Devices (CECMED). CIMAvax®-EGF. (Conjugado químico de Factor de Crecimiento Epidérmico humano recombinante acoplado a la proteína recombinante rP64K). CIMAvax®-EGF. Vacuna terapéutica indicada para pacientes con cáncer de pulmón de células no pequeñas, en estadios avanzados (IIIb/IV). Titular del Registro Sanitario: Centro de Inmunología Molecular, Cuba. Fecha de Inscripción: 12 de Junio de 2008 [Internet]. Havana: Center for State Control of Medicines, Equipment and Medical Devices (CECMED); 2008 [cited 2018 Oct 15]. Available from: https://www.cecmed.cu/sites/ default/files/adjuntos/rcp/biologicos/rcp_ci ma-vax_egf.pdf. Spanish.

  55. Silva R, Selman M, Guillén G, Herrera L, Fernández JR, Novoa LI, et al. Nucleotide sequence coding for an outer membrane protein from Neisseria meningitidis and use of said protein in vaccine preparations. EP 0474313 A2. [Internet]. Canberra: Lens.org; 1992 Mar 11 [cited 2018 Oct 15]. Available from: https://www.lens.org/lens/ patent/EP_0474313_A2

  56. Rodríguez Martínez GM, Viña Rodríguez L, Calvo González L, Cuevas Fiallo A, Chico Véliz E, Crombet Ramos T, et al. Production of an homogeneous vaccine preparation for cancer treatment. WO 2009/003425 Al [Internet]. Canberra: Lens.org; 2012 Mar 21 [cited 2018 Oct 15]. Available from: https://www .lens.org/lens/patent/PT_2184072_E 1

  57. Menéndez Medina T, Cruz Leal Y, Coizeau Rodríguez E, Guillén Nieto GE, Santiago Vispo NF, Cinza Estévez Z, et al. Mimotopes of capsular polysaccharides of neisseria meningitidis and pharmaceuti cal formulations. WO 2007/087758 A2 [Internet]. California: Google Patterns; 2007 Nov 15 [cited 2018 Oct 15]. Available from: https:// patents.google.com/patent/WO2007087758A2/

  58. Campa Huergo C, Sierra González G, Gutiérrez Vázquez MM, Bisset Jorrín G, García Imia LG, Puentes Rizo GC, et al. Method of producing of an anti-meningococ hyperimmune gamma globulin and gamma globulin produced by method. United States Patent Number: 5,747,653 [Internet]. California: Google Patents; 1998 May 5 [cited 2018 Oct 15]. Available from: https://patents .google.com/patent/US5747653A/en

  59. Tania Crombet R, Rodríguez PC, Neninger Vinageras E, García Verdecia B, Lage Dávila A. CIMAvax EGF (EGF-P64K) vaccine for the treatment of non-small-cell lung cancer. Expert Rev Vaccines [Internet]. 2015 [cited 2018 Oct 15];14(10):1303–11. Available from: http://dx.doi .org/10.1586/14760584.2015.1079488

  60. Zulueta A, Hermida L, Lazo L, Valdés I, Rodríguez R, López C, et al. The fusion site of envelope fragments from each serotype of Dengue virus in the P64k protein, in uence some parameters of the resulting chimeric constructs. Biochem Biophys Res Commun. 2003 Aug 29;308(3):619–26.

  61. Ochoa RF, Sierra G. Vacunas contra la enfermedad meningocócica. In: Ochoa RF, Menéndez J, editors. Prevención de la enfermedad meningocócica.1st ed. Havana: Finlay Ediciones; 2010. p. 67–84. Spanish.

  62. Rico O, Almeyda L. Impacto de la vacunación con VA-MENGOC-BC en los niños menores de seis años en algunas provincias de Cuba. Rev Soc Argentina Pediatr Filial Córdoba.1994;3(3):65–8. Spanish.

  63. Costa EA, Martins H, Klein CH. Avaliação da proteção conferida pela vacina antimeningocócica BC no Estado de Santa Catarina, Brazil, 1990/92. Rev Saúde Pública. 1996 Apr;30(5):460–70. Portuguese.

  64. Noronha CP, Struchiner CJ, Halloran ME. Assessment of the direct effectiveness of BC meningococcal vaccine in Rio de Janeiro, Brazil: a case-control study. Int J Epidemiol. 1995 Oct;24(5):1050–7.

  65. de Moraes JC, Perkins BA, Camargo MCC, Hidalgo NT, Barbosa HA, Sacchi CT, et al. Protective ef cacy of a serogroup B meningococcal vaccine in Sao Paulo, Brazil. Lancet. 1992 Oct 31;340(8827):1074–8.

  66. Costa EA, Amaral JC, Juárez E. E cácia da vacina antimeningocócica (VA-MENGOC-BC®) nas condições de uso no Brasil, no período 1989/90. Inf Epidemiol SUS. 1994;3(2):35–9. Portuguese.

  67. Galeano LA, Echeverry ML. Efectividad de una vacuna antimeningocóccica en una cohorte de Itaguí, Colombia, 1995. Bol Epidemiol Antioquia. 1995;20(2):110–8. Spanish.

  68. Pírez MC, Picón T, Galazka J, Rubio I, Montano A, Ferrari AM. Control de un brote epidémico de enfermedad meningocócica por Neisseria meningitidis serogrupo B. Rev Méd Urug. 2004 Aug;20(2):92–101. Spanish.

  69. Ochoa-Azze RF. Cross-protection induced by VA-MENGOC-BC vaccine. Hum Vaccin Immunother [Internet]. 2018 Feb 26 [cited 2019 Jan 8];14(5):1064–8. Available from: https://doi.org/1 0.1080/21645515.2018.1438028

  70. Ochoa-Azze RF, García-Imía L, Vérez-Bencomo V. Effectiveness of a Serogroup B and C Meningococcal vaccine developed in Cuba. MEDICC Rev. 2018 Jul;20(3):22–9.

  71. Ochoa-Azze R, García-Imia L. Efectividad de la vacuna VA-MENGOC-BC® contra cepas heterólogas de meningococo B. VacciMonitor. 2016 Aug;25(2):43–8. Spanish.




2020     |     www.medigraphic.com