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2015, Número 4

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MEDICC Review 2015; 17 (4)


Safety and immunogenicity of cuban antipneumococcal conjugate vaccine PCV7-TT in healthy adults

González GN, Paredes MB, Pérez RS, Mirabal SM, Rivero VI, González DCA, Díaz MA, García RD, Rodríguez NL, Pérez BA, Soroa MY, Santana MD, Álvarez LA, Valdés BY, Vérez BV

Idioma: Ingles.
Referencias bibliográficas: 31
Paginas: 32-37
Archivo PDF: 273.57 Kb.


RESUMEN

Sin resumen.


REFERENCIAS (EN ESTE ARTÍCULO)

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  2. Verma R, Khanna P. Pneumococcal conjugate vaccine: A newer vaccine available in India. Hum Vaccin Immunother. 2012 Sep;8(9):1317–20.

  3. Hausdorff WP, Feikin DR, Klugman KP. Epidemiological differences among pneumococcal serotypes. Lancet Infect Dis. 2005 Feb;5(2):83–93.

  4. Welte T. How can we reduce the mortality of invasive pneumococcal disease? Eur Respir Rev. 2012 Mar 1;21(123):6–7.

  5. Fitzwater SP, Chandran A, Santosham M, Johnson HL. The worldwide impact of the sevenvalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2012 May;31(5):501–8.

  6. Mongardon N, Max A, Bouglé A, Pène F, Lemiale V, Charpentier J, et al. Epidemiology and outcome of severe pneumococcal pneumonia admitted to intensive care unit: a multicenter study. Crit Care. 2012 Aug 15;16(4):R155.

  7. Tan TQ. Pediatric invasive pneumococcal disease in the United States in the era of pneumococcal conjugate vaccines. Clin Microbiol Rev. 2012 Jul;25(3):409–19.

  8. Menon VJ, Corscadden KJ, Fuery A, Thorn-ton RB, Kirkham LA, Richmond PC, et al. Children with otitis media mount a pneumococcal serotype specific serum IgG and IgA response comparable to healthy controls after pneumococcal conjugate vaccination. Vaccine. 2012 Apr 26;30(20):3136– 44.

  9. Grabenstein JD, Klugman KP. A century of pneumococcal vaccination research in humans. Clin Microbiol Infect. 2012 Oct;18 Suppl 5:15–24.

  10. Johnson HL, Deloria-Knoll M, Levine OS, Stoszek SK, Freimanis Hance L, Reithinger R, et al. Systematic evaluation of serotypes causing invasive pneumococcal disease among children under five: the pneumococcal global serotype project. PLoS Med. 2010 Oct 5;7(10). DOI: 10.1371/journal.pmed.1000348.

  11. World Health Organization. Part I: Target Product Profile (TPP) for the Advance Market Commitment (AMC) for pneumococcal conjugate vaccines, Master Table [Internet]. Geneva: World Health Organization; 2008 Feb 22 [cited 2011 Sep 27]. Available from: http://www.who.int/ immunization/sage/target_product_profile.pdf

  12. Castaneda E, Agudelo CI, Regueira M, Corso A, Brandileone MC, Brandão AP, et al. Laboratorybased surveillance of Streptococcus pneumoniae invasive disease in children in 10 Latin American countries: a SIREVA II project, 2000–2005. Pediatr Infect Dis J. 2009 Sep;28(9):e265–70.

  13. Toraño Peraza GT, Llanes Caballero R, Pías Solís LM, Abreu Capote M, Valcárcel Sánchez M. Serotipos de Streptococcus pneumoniae en Cuba y progresión de la resistencia a la penicilina. Rev Cubana Med Trop. 2010 May– Aug;2(62):157–60. Spanish.

  14. Rodríguez M, Pérez A, Dickinson F, Toraño G, Toledo I, Feliciano O, et al. Meningitis bacteriana en Cuba, enero-junio de 2009-2010. Boletín IPK. 2010 Oct 2;20(39):305–12. Spanish.

  15. Center for Disease Control and Prevention (CDC). Licensure of 13-valent pneumococcal conjugate vaccine for adults aged 50 years and older. MMWR Morb Mortal Wkly Rep. 2012 Jun 1;61(21):394–5.

  16. Pan American Health Organization. Informe Regional de SIREVA II, 2009: Datos por país y por grupos de edad sobre las características de los aislamientos de Streptococcus pneumoniae, Haemophilus influenzae y Neisseria meningitidis, en procesos invasores [Internet]. Washington, D.C.: Pan American Health Organization; 2010 [cited 2014 Jan 11]. 306 p. Available from: http://new.paho.org/hq/dmdocuments/2010/ SIRVA%20II%202009.pdf. Spanish.

  17. Pan American Health Organization. Informe Regional de SIREVA II, 2010: datos por país y por grupos de edad sobre las características de los aislamientos de Streptococcus pneumoniae, Haemophilus influenzae y Neisseria meningitidis, en procesos invasores [Internet]. Washington, D.C.: Pan American Health Organization; 2011 [cited 2014 Jan 11]. 315 p. Available from: http://www.paho.org/hq/index.php?option=com _docman&task=doc_download&gid=14772&Ite mid=&lang=es. Spanish.

  18. Viada González CE, Ballagas Flores C, Blanco López Y. Ética en la investigación con poblaciones especiales. Rev Cubana Invest Biomed. 2001 Apr–Jun;20(2):140–9. Spanish.

  19. World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects [Internet]. Ferney-Voltaire (FR): World Medical Association; 2008 Oct [cited 2011 Jan 15]. 5 p. Available from: http://www .wma.net/en/30publications/10policies/b3/17c .pdf

  20. National Drugs Quality Control Center (CU). Buenas Prácticas Clínicas en Cuba [Internet]. Havana: Ministry of Public Health (CU); 2000 [cited 2014 Dec 12]. 48 p. Available from: http:// www.cecmed.cu/sites/default/files/adjuntos/ Reglamentacion/Dir_BPC.pdf. Spanish.

  21. Scott DA, Komjathy SF, Hu BT, Baker S, Supan LA, Monahan CA, et al. Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2007 Aug 14;25(33):6164–6.

  22. Scott D, Ruckle J, Dar M, Baker S, Kondoh H, Lockhart S. Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults. Pediatr Int. 2008 Jun;50(3):295–9.

  23. Oosterhuis-Kafeja F, Beutels P, Van Damme P. Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998–2006). Vaccine. 2007 Mar 8;25(12):2194– 212.

  24. Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, et al. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group. Pediatr Infect Dis J. 2000 Mar;19(3):187–95.

  25. Peña MA, Valera R, Mirabal M, Rodríguez M, Armesto M, Menéndez J, et al. Propuesta de un algoritmo para evaluar la causalidad de eventos adversos en los ensayos clínicos de vacunas. Vaccimonitor [Internet]. 2008 Sep– Dec [cited 2014 Feb 5];17(3):21–6. Available from: http://scielo.sld.cu/scielo.php?pid=S1025 -028X2008000300004&script=sci_arttext. Spanish.

  26. National Drugs Quality Control Center (CU). Requerimientos para la notificación y el reporte de eventos adversos graves e inesperados en los ensayos clínicos autorizados. Havana: Ministry of Public Health (CU); 2007 [cited 2013 Dec 3]. 18 p. Available from: www.bvv.sld.cu/down load.php?url=regulaciones/124413435046.doc. Spanish.

  27. Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161–7.

  28. World Health Organization. Training manual for enzyme linked immunosorbent assay for the quantitation of Streptococcus pneumoniae serotype specific IgG (Pn PS ELISA) [Internet]. Geneva: World Health Organization; 2002 Nov [cited 2013 Dec 26]. 29 p. Available from: http://www .vaccine.uab.edu/ELISA%20protocol.pdf

  29. Jackson LA, Gurtman A, van Cleeff M, Jansen KU, Jayawardene D, Devlin C, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. Vaccine. 2013 Aug 2;31(35):3577–84.

  30. Spijkerman J, Veenhoven RH, Wijmenga-Monsuur AJ, Elberse KE, van Gageldonk PG, Knol MJ, et al. Immunogenicity of 13-valent pneumococcal conjugate vaccine administered according to 4 different primary immunization schedules in infants: a randomized clinical trial. JAMA. 2013 Sep 4;310(9):930–7.

  31. Lee LH, Frasch CE, Falk LA, Klein DL, Deal CD. Correlates of immunity for pneumococcal conjugate vaccines. Vaccine. 2003 May 16;21(17– 18):2190–6.




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