2017, Number S1
<< Back
Rev Cubana Pediatr 2017; 89 (S1)
New Cuban pneumococcal vaccine, from available scientific evidence to the strategy of clinical and impact evaluation
Linares-Pérez N, Toledo-Romaní ME, Casanova GMF, Paredes MB, Váldes BY, Santana MD, García RD, Toraño PG, Dotres MC, Puga GR, Verez-Bencomo V
Language: Spanish
References: 38
Page: 181-196
PDF size: 169.09 Kb.
ABSTRACT
This paper summarized the group of evidence that supports the present use of the
pneumococcal conjugate vaccines in terms of safety, immunogenicity, efficacy and
effectiveness. It offers a new alternative to prevent the pneumococcal disease in the
infant population on the basis of a new Cuban vaccinal candidate against
pneumococci. It set out the basic principles that define the strategy for the
introduction of this vaccine in Cuba and the advances resulting from the use of an
integrated model for the clinical evaluation and the impact on health, in its
implementation phase, which seeks to provide the scientific evidence backing up the
decision of the national health care system to introduce this vaccine in the national
immunization schedule and its further commercialization in the era of pneumococcal
conjugate vaccines. Preliminary results of finished studies were presented and the
conclusions on the scientific and practical contributions of the strategy of
implementation and the evaluation model for the new vaccine were worked out.
REFERENCES
Chan-Acón W, Abdelnour A, Soley-Gutiérrez C, Arguedas-Mohs A. Update on Pneumococcal Conjugate Vaccines. Acta Méd Costarric. 2010;52(3):137-47.
Fedson DS, Nicolas-Spony L, Klemets P, van der Linden M, Marques A. Pneumococcal polysaccharide vaccination for adults: new perspectives for Europe. Exp Rev Vaccines. 2011;10(8):1143-67.
Gabastou JM, Gabastou JM, Agudelo CI, Brandileone MC, Castañeda E, Lemos APSD, Di Fabio JL. Characterization of invasive isolates of S. pneumoniae, H. influenzae, and N. meningitidis in Latin America and the Caribbean: SIREVA II, 2000- 2005. Revista Panamericana de Salud Pública. 2008;24(1):1-15.
Fedson DS, Anthony J, Scott G. The burden of pneumococcal disease among adults in developed and developing countries: what is and is not known. Vaccine. 1999;17:S11-S18.
Cuba. Minsap. Consenso nacional para el diagnóstico y tratamiento de la neumonía adquirida en la comunidad en Pediatría. La Habana, Cuba; 2013.
Toledo ME, Casanova MF, Linares-Pérez N, García-Rivera D, Toraño Peraza G, Barcos Pina I, et al. Prevalence of Pneumococcal nasopharyngeal carriage among children 2-18 months old: baseline study pre-introduction of pneumococcal vaccination in Cuba. The Pediatric Infection Diseases Journal. April, 21th, 2016. (En prensa).
Toraño-Peraza G, Pías-Solis L, Abreu-Capote M, Rodríguez-Ortega M, Dickinson- Meneses F, Varcárcel-Sánchez M. Serotipos y resistencia antimicrobiana de aislamientos meníngeos de Streptococcus pneumoniae. Cuba, 2007-2012. Vaccimonitor. 2014;23(3):117-23.
Dickinson Meneses FR, Toraño Peraza G. Pneumococcal meningitis in Cuban children and adolescents: A fifteen years follow up. Pediatrics Research International Journal. 2015;2015. doi: 10.5171/2015. 596251. p. 1-11.
Centers for Disease Control and Prevention (CDC). Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2000;49:1-35.
WHO. Global Health Workforce Alliance: GAVI-The Global Alliance for Vaccines and Immunizations [homepage en Internet]; WHO, 2016 [citado 3 de Junio de 2016]. Disponible en: http://www.who.int/workforcealliance/members_partners/member_list/gavi/en/
Word Health Organization. Pneumococcal vaccines WHO position paper-2012- recommendations. Vaccine. 2012;30(32):4717-8.
Andrus JK, Quadros CD, Matus CR, Luciani S. New Vaccines for Developing Countries: Will It Be Fest or Famine. Am JL & Med. 2009;35:311.
Zamorano J. Nuevas vacunas antineumocócicas conjugadas: recorriendo su éxito. Medwave. 2010;10(2):122-9.
Oosterhuis F, Beutels F, Van Damme P. Immunogenicity, efficacy, safety and effectiviness of pneumococcal conjugate vaccines (1998-2006). Vaccine. 2007;25:2194-212.
Agencia Europea de Medicamentos (EMEA). Ficha técnica o resumen de las características del producto: Prevenar suspensión inyectable [homepage en Internet]; Madrid, 2008 [citado 12 de julio de 2016]. Disponible en: https://rxed.eu/es/p/Prevenar/2/
Pavia M, Bianco A, Nobile CG, Marinelli P, Angelillo IF. Efficacy of pneumococcal vaccination in children younger than 24 months: a meta-analysis. Pediatrics. 2009;123(6):e1103-e10.
Pilishvili T, Lexau C, Farley MM, Hadler J, Harrison LH, Bennett NM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. The Journal of Infectious Diseases. 2010;201(1):32-41.
Loo JD, Conklin L, Fleming-Dutra KE, Knoll MD, Park DE, Kirk J, et al. Systematic review of the indirect effect of pneumococcal conjugate vaccine dosing schedules on pneumococcal disease and colonization. The Pediatric Infectious Disease Journal. 2014;33:S161-S71.
Thompson A, Gurtman A, Patterson S, Juergens C, Laudat F, Emini EA, et al. Safety of 13-valent pneumococcal conjugate vaccine in infants and children: metaanalysis of 13 clinical trials in 9 countries. Vaccine. 2013;31(45):5289-95.
Knoll MD, Park DE, Johnson TS, Chandir S, Nonyane BAS, Conklin L, et al. Systematic review of the effect of pneumococcal conjugate vaccine dosing schedules on immunogenicity. The Pediatric Infectious Disease Journal. 2014;33(supp 2):S119.
Fleming-Dutra KE, Conklin L, Loo JD, Knoll MD, Park DE, Kirk J, et al. Systematic review of the effect of pneumococcal conjugate vaccine dosing schedules on vaccinetype nasopharyngeal carriage. The Pediatric Infectious Disease Journal. 2014;33(supp 2):S152.
Conklin L, Loo JD, Kirk J, Fleming-Dutra KE, Knoll MD, Park DE, et al. Systematic review of the effect of pneumococcal conjugate vaccine dosing schedules on vaccinetype invasive pneumococcal disease among young children. The Pediatric Infectious Disease Journal. 2014;33(suppl 2):S109.
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. The Pediatric Infectious Disease Journal. 2000;19(3):187-95.
Park DE, Johnson TS, Nonyane BAS, Chandir S, Conklin L, Fleming-Dutra KE, et al. The differential impact of coadministered vaccines, geographic region, vaccine product and other covariates on pneumococcal conjugate vaccine immunogenicity. The Pediatric Infectious Disease Journal. 2014;33(supp 2):S130.
Denoël P, Philipp MT, Doyle L, Martin D, Carletti G, Poolman JT. A protein-based pneumococcal vaccine protects rhesus macaques from pneumonia after experimental infection with Streptococcus pneumoniae. Vaccine. 2011;29(33):5495-501.
Briles DE, Tart RC, Swiatlo E, Dillard JP, Smith P, Benton KA, et al. Pneumococcal diversity: considerations for new vaccine strategies with emphasis on pneumococcal surface protein A (PspA). Clinical Microbiology Reviews.1998;11(4):645-57.
Ogunniyi AD, Grabowicz M, Briles DE, Cook J, Paton JC. Development of a vaccine against invasive pneumococcal disease based on combinations of virulence proteins of Streptococcus pneumoniae. Infection and Immunity. 2007;75(1):350-7.
Croxtall JD, Keating GM. Pneumococcal polysaccharide protein D-conjugate vaccine (Synflorix™; PhiD-CV). Pediatric Drugs. 2009;11(5):349-57.
Grant LR, O'Brien SE, Burbidge P, Haston M, Zancolli M, Cowell L, et al. Comparative immunogenicity of 7 and 13-valent pneumococcal conjugate vaccines and the development of functional antibodies to cross-reactive serotypes. PloSon. 2013;8(9):e74906.
Fox LL, Hornecker JR. Pneumococcal Vaccination: Optimizing Preventive Strategies and Reducing Disease Burden. US Pharm. 2014;39(4):23-6.
Hortal M, Ruvinsky R, Rossi A, Agudelo CI, Castañeda E, Brandileone C, et al. Impacto de Streptococcus pneumoniae en las neumonías del niño latinoamericano. Grupo SIREVA-Vigía. Pan American Journal of Public Health. 2000;8:185-95.
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 Medicine. 2010;7(10):1251.
Castañeda E, Agudelo CI, Regueira M, Corso A, de Cunto Brandileone MC, Brandão AP, et al. Laboratory-based surveillance of Streptococcus pneumoniae invasive disease in children in 10 Latin American countries: a SIREVA II project, 2000-2005. The Pediatric Infectious Disease Journal. 2009;28(9):e265-e70.
González N, Paredes B, Pérez S, Mirabal M, Rivero I, González C, et al. Safety and immunogenicity of Cuban antipneumococcal conjugate vaccine PCV7-TT in healthy adults. MEDICC Review. 2015;17(4):32-7.
Dotres CP, Puga R, Ricardo Y, Brono CR, Paredes B, Echemendia V, et al. Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: A randomized phase I clinical trial. Vaccine. 2014;32(41):5266- 70.
Gray BM, Converse GM, Dillon HC. Epidemiologic studies of Streptococcus pneumoniae in infants: acquisition, carriage, and infection during the first 24 months of life. Journal of Infectious Diseases. 1980;142(6):923-33.
Clark A, Jauregui B, Griffiths U, Janusz CB, Bolanos-Sierra B, Hajjeh R, et al. TRIVAC decision-support model for evaluating the cost-effectiveness of Haemophilus influenzae type b, pneumococcal and rotavirus vaccination. Vaccine. 2013;31:C19- C29.
Andrus JK, Toscano CM, Lewis M, Oliveiria L, Ropero AM, Dávila M, et al. A model for enhancing evidence-based capacity to make informed policy decisions on the introduction of new vaccines in the Americas: PAHO's ProVac initiative. Public Health Reports. 2007;122(6):811.