medigraphic.com
ISSN 1561-3011 (Digital)

2016, Número 1

<< Anterior Siguiente >>

Rev Cubana Invest Bioméd 2016; 35 (1)


Seguridad e inmunogenicidad en ensayos clínicos de vacunas para Dengue

Reyes CJC, Cardona-Arias JA, López JÁ, Martinez-Gutierrez M

Idioma: Español
Referencias bibliográficas: 72
Paginas: 78-90
Archivo PDF: 431.02 Kb.


RESUMEN

Introducción: uno de los obstáculos para el licenciamiento de una vacuna para Dengue es la variabilidad de los estudios, lo que dificulta su análisis en conjunto para llegar a conclusiones confiables.
Objetivos: desarrollar una revisión sistemática de literatura para analizar la seguridad e inmunogenicidad de las diferentes vacunas para Dengue.
Métodos: la búsqueda de información fue realizada en Cochrane Library, Scopus, Science Direct, PubMed, Nature, Lilacs y OvidSp por metodología de cosecha de perlas de acuerdo a los criterios de inclusión.
Resultados: se seleccionaron 42 artículos. Los principales síntomas reportados en los estudios incluyeron eritema, dolor y sensibilidad. Se encontró gran discrepancia en cuanto a la definición de seropositividad y gran variabilidad en relación a los Títulos de Media Geométrica reportados en cada estudio.
Conclusiones: se encontró una gran variabilidad en los estudios en relación a diseño y reporte de datos de seguridad e inmunogenicidad.


REFERENCIAS (EN ESTE ARTÍCULO)

  1. Lindenbach BD, Thiel HJ, Rice CM. Flaviviridae: The Viruses and Their Replication. Fields Virology. 5th Edition. Philadelphia: Lippincott-Raven Publishers; 2007.

  2. Murphy BR, Whitehead SS. Immune response to dengue virus and prospects for a vaccine. Annual review of immunology. 2011;29:587-619.

  3. Urcuqui-Inchima S, Patino C, Torres S, Haenni AL, Diaz FJ. Recent developments in understanding dengue virus replication. Advances in virus research. 2010;77:1-39.

  4. Russell PK, Nisalak A. Dengue virus identification by the plaque reduction neutralization test. The Journal of Immunology. 1967;99(2):291-6.

  5. Mustafa M, Rasotgi V, Jain S, Gupta V. Discovery of fifth serotype of dengue virus (DENV-5): A new public health dilemma in dengue control. Medical Journal Armed Forces India. 2015;71(1):67-70.

  6. Rodriguez-Roche R, Gould EA. Understanding the dengue viruses and progress towards their control. BioMed research international. 2013;2013:690835.

  7. Back AT, Lundkvist A. Dengue viruses - an overview. Infection ecology & epidemiology. 2013 [citado 14 Jul 2015];3. Disponible en: http://www.infectionecologyandepidemiology.net/index.php/iee/article/view/19839

  8. WHO. Report of the Scientific Working Group meeting on Dengue. World Health Organization; 2006.

  9. OMS, TDR. Dengue: guias para el diagnóstico, tratamiento, prevención y control. Bolivia: OMS; 2009.

  10. INS, OPS, OMS. Guía para la atención clínica integral del paciente con dengue. Bogotá; 2010.

  11. McArthur MA, Sztein MB, Edelman R. Dengue vaccines: recent developments, ongoing challenges and current candidates. Expert review of vaccines. 2013;12(8):933-53.

  12. Santacoloma Varón L, Chaves Córdoba B, Brochero HL. Susceptibility of Aedes aegypti to DDT, deltamethrin, and lambda-cyhalothrin in Colombia. Revista Panamericana de Salud Pública. 2010;27(1):66-73.

  13. Lim SP, Wang Q-Y, Noble CG, Chen Y-L, Dong H, Zou B, et al. Ten years of dengue drug discovery: progress and prospects. Antiviral research. 2013;100(2):500-19.

  14. Thomas SJ, Endy TP. Critical issues in dengue vaccine development. Current opinion in infectious diseases. 2011;24(5):442-50.

  15. Yauch LE, Shresta S. Dengue virus vaccine development. Advances in virus research. 2014;88:315-72.

  16. McArthur MA, Sztein MB, Edelman R. Dengue vaccines: recent developments, ongoing challenges and current candidates. Expert Reviews of Vaccines. 2013;13:933-53.

  17. Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews; 2015.

  18. Urrútia G, Bonfill X. Declaración PRISMA: una propuesta para mejorar la publicación de revisiones sistemáticas y metaanálisis. Medicina clínica. 2010;135:507-11.

  19. Organization WH. Dengue: Guías para el diagnóstico, tratamiento, prevención y control. OPS/OMS La Paz; 2009.

  20. Alonso MA. Estudios Pequeños: ¿ Cuál es la Importancia del Tamaño en los Estudios Clínicos? Medwave. 2011;6:1-3

  21. Julian P, Higgins D, Peter CG, Peter J, Moher D, Oxman A, et al. Cochrane Bias Methods Group, Cochrane Statistical Methods Group. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ; 2011.

  22. Scott EK, Bancroft WH, Summers PL, McCown JM, Anderson JH, Russell PK, et al. Dengue 2 vaccine: dose response in volunteers in relation to yellow fever immune status. J Infect Dis. 1983;148(6):1055-60.

  23. The Cochrane Collaboration. Manual Cochrane de revisiones sistemáticas de intervenciones. Centro Cochrane Iberoamericano; 2011.

  24. Cobos-Carbó A. Ensayos clínicos aleatorizados (CONSORT). Medicina clínica. 2005;125:21-7.

  25. Fletcher R. Epidemiologia clínica: Lippincott Williams and Wilkins. Wolters Kluwer Health; 2008.

  26. Sun W, Edelman R, Kanesa-Thasan N, Eckels KH, Putnak JR, King AD, et al. Vaccination of human volunteers with monovalent and tetravalent live-attenuated dengue vaccine candidates. Am J Trop Med Hyg. 2003;69(6 Suppl):24-31.

  27. Kanesa-thasan N, Sun W, Kim-Ahn G, Van Albert S, Putnak JR, King A, et al. Safety and immunogenicity of attenuated dengue virus vaccines (Aventis Pasteur) in human volunteers. Vaccine. 2001;19(23-24):3179-88.

  28. Organization WH. Correlates of vaccine-induced protection: methods and implications. World Health Organization; 2013.

  29. Hombach J, Cardosa M, Sabchareon A, Vaughn DW, Barrett AD. Scientific consultation on immunological correlates of protection induced by dengue vaccines. Report from a meeting held at the World Health Organization 17-18 November 2005. Vaccine. 2007;25:4130-9.

  30. Sabchareon A, Wallace D, Sirivichayakul C, Limkittikul K, Chanthavanich P, Suvannadabba S, et al. Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial. Lancet. 2012;380(9853):1559-67.

  31. Timiryasova TM, Bonaparte MI, Luo P, Zedar R, Hu BT, Hildreth SW, et al. Optimization and validation of a plaque reduction neutralization test for the detection of neutralizing antibodies to four serotypes of dengue virus used in support of dengue vaccine development. Am J Trop Med Hyg. 2013;88(5):962-70.

  32. Roehrig JT, Hombach J, Barrett AD. Guidelines for Plaque-Reduction Neutralization Testing of Human Antibodies to Dengue Viruses. Viral immunology. 2008;21(2):123-32.

  33. da Costa VG, Marques-Silva AC, Floriano VG, Moreli ML. Safety, immunogenicity and efficacy of a recombinant tetravalent dengue vaccine: a meta-analysis of randomized trials. Vaccine. 2014;32(39):4885-92.

  34. Dayan GH, Thakur M, Boaz M, Johnson C. Safety and immunogenicity of three tetravalent dengue vaccine formulations in healthy adults in the USA. Vaccine. 2013;31(44):5047-54.

  35. Poo J, Galan F, Forrat R, Zambrano B, Lang J, Dayan GH, et al. Live-attenuated Tetravalent Dengue Vaccine in Dengue-naive Children, Adolescents, and Adults in Mexico City: Randomized Controlled Phase 1 Trial of Safety and Immunogenicity. The Pediatric infectious disease journal. 2010.

  36. Capeding RZ, Luna IA, Bomasang E, Lupisan S, Lang J, Forrat R, et al. Liveattenuated, tetravalent dengue vaccine in children, adolescents and adults in a dengue endemic country: randomized controlled phase I trial in the Philippines. Vaccine. 2011;29(22):3863-72.

  37. Morrison D, Billings CW, Forrat R, Yoksan S, Lang J. A novel tetravalent dengue vaccine is well tolerated and immunogenic against all 4 serotypes in flavivirus-naive adults. J Infect Dis. 2010;201(3):370-7.

  38. Qiao M, Shaw D, Forrat R, Wartel-Tram A, Lang J. Priming effect of dengue and yellow fever vaccination on the immunogenicity, infectivity, and safety of a tetravalent dengue vaccine in humans. Am J Trop Med Hyg. 2011;85(4):724-31.

  39. Leo YS, Wilder-Smith A, Archuleta S, Shek LP, Chong CY, Leong HN, et al. Immunogenicity and safety of recombinant tetravalent dengue vaccine (CYD-TDV) in individuals aged 2-45 y: Phase II randomized controlled trial in Singapore. Human vaccines & immunotherapeutics. 2012;8(9):1259-71.

  40. Ngoc Huu Tran CQL, Thi Que Huong Vu, Remi Forrat, Jean Lang, Quoc Dat Vu, Alain Bouckenooghe, et al. Safety and Immunogenicity of Recombinant, Live Attenuated Tetravalent Dengue Vaccine (CYD- TDV) in Healthy Vietnamese Adults and Children. Vaccines Vaccin. 2012;3:162.

  41. Lanata CF, Andrade T, Gil AI, Terrones C, Valladolid O, Zambrano B, et al. Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru. Vaccine. 2012;30(41):5935-41.

  42. Dayan GH, Garbes P, Noriega F, Izoton de Sadovsky AD, Rodrigues PM, Giuberti C, et al. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg. 2013;89(6):1058-65.

  43. Hss AS, Koh MT, Tan KK, Chan LG, Zhou L, Bouckenooghe A, et al. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2-11 years in Malaysia: a randomized, placebo-controlled, Phase III study. Vaccine. 2013;31(49):5814-21.

  44. Villar LA, Rivera-Medina DM, Arredondo-Garcia JL, Boaz M, Starr-Spires L, Thakur M, et al. Safety and immunogenicity of a recombinant tetravalent dengue vaccine in 9-16 year olds: a randomized, controlled, phase II trial in Latin America. The Pediatric infectious disease journal. 2013;32(10):1102-9.

  45. Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, et al. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebocontrolled trial. Lancet. 2014;384(9951):1358-65.

  46. Sun W, Cunningham D, Wasserman SS, Perry J, Putnak JR, Eckels KH, et al. Phase 2 clinical trial of three formulations of tetravalent live-attenuated dengue vaccine in flavivirus-naive adults. Hum Vaccin. 2009;5(1):33-40.

  47. Watanaveeradej V, Gibbons RV, Simasathien S, Nisalak A, Jarman RG, Kerdpanich A, et al. Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial. Am J Trop Med Hyg. 2014;91(1):119-28.

  48. Edelman R, Wasserman SS, Bodison SA, Putnak RJ, Eckels KH, Tang D, et al. Phase I trial of 16 formulations of a tetravalent live-attenuated dengue vaccine. Am J Trop Med Hyg. 2003;69(6 Suppl):48-60.

  49. Thomas SJ, Eckels KH, Carletti I, De La Barrera R, Dessy F, Fernandez S, et al. A phase II, randomized, safety and immunogenicity study of a re-derived, liveattenuated dengue virus vaccine in healthy adults. The American journal of tropical medicine and hygiene. 2013;88(1):73-88.

  50. Simasathien S, Thomas SJ, Watanaveeradej V, Nisalak A, Barberousse C, Innis BL, et al. Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus naive children. The American journal of tropical medicine and hygiene. 2008;78(3):426-33.

  51. Watanaveeradej V, Simasathien S, Nisalak A, Endy TP, Jarman RG, Innis BL, et al. Safety and immunogenicity of a tetravalent live-attenuated dengue vaccine in flavivirus-naive infants. The American journal of tropical medicine and hygiene. 2011;85(2):341-51.

  52. Kanesa-Thasan N, Edelman R, Tacket CO, Wasserman SS, Vaughn DW, Coster TS, et al. Phase 1 studies of Walter Reed Army Institute of Research candidate attenuated dengue vaccines: selection of safe and immunogenic monovalent vaccines. Am J Trop Med Hyg. 2003;69(6 Suppl):17-23.

  53. Lindow JC, Durbin AP, Whitehead SS, Pierce KK, Carmolli MP, Kirkpatrick BD. Vaccination of volunteers with low-dose, live-attenuated, dengue viruses leads to serotype-specific immunologic and virologic profiles. Vaccine. 2013;31(33):3347-52.

  54. Durbin AP, Schmidt A, Elwood D, Wanionek KA, Lovchik J, Thumar B, et al. Heterotypic dengue infection with live attenuated monotypic dengue virus vaccines: implications for vaccination of populations in areas where dengue is endemic. Journal of Infectious Diseases. 2011;203(3):327-34.

  55. Amar-Singh H, Koh M-T, Tan KK, Chan LG, Zhou L, Bouckenooghe A, et al. Safety and immunogenicity of a tetravalent dengue vaccine in healthy children aged 2-11 years in Malaysia: A randomized, placebo-controlled, Phase III study. Vaccine. 2013;31(49):5814-21.

  56. Kitchener S, Nissen M, Nasveld P, Forrat R, Yoksan S, Lang J, et al. Immunogenicity and safety of two live-attenuated tetravalent dengue vaccine formulations in healthy Australian adults. Vaccine. 2006;24(9):1238-41.

  57. Sabchareon A, Lang J, Chanthavanich P, Yoksan S, Forrat R, Attanath P, et al. Safety and immunogenicity of tetravalent live-attenuated dengue vaccines in Thai adult volunteers: role of serotype concentration, ratio, and multiple doses. The American journal of tropical medicine and hygiene. 2002;66(3):264-72.

  58. Durbin AP, Kirkpatrick BD, Pierce KK, Elwood D, Larsson CJ, Lindow JC, et al. A single dose of any of four different live attenuated tetravalent dengue vaccines is safe and immunogenic in flavivirus-naive adults: a randomized, double-blind clinical trial. Journal of Infectious Diseases. 2013;207(6):957-65.

  59. Osorio JE, Velez ID, Thomson C, Lopez L, Jimenez A, Haller AA, et al. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebocontrolled, phase 1 study. The Lancet Infectious Diseases. 2014;14(9):830-8.

  60. Edelman R, Tacket CO, Wasserman SS, Vaughn DW, Eckels KH, Dubois DR, et al. A Live Attenuated Dengue-L Vaccine Candidate (45AZ5) Passaged In Primary Dog Kidney Cell Culture Is Attenuated And Immunogenic For Humans. Journal of Infectious Diseases. 1994;170(6):1448-55.

  61. Beckett CG, Tjaden J, Burgess T, Danko JR, Tamminga C, Simmons M, et al. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine. 2011;29(5):960-8.

  62. Durbin AP, McArthur J, Marron JA, Blaney J, Joseph E, Thumar B, et al. The live attenuated dengue serotype 1 vaccine rDEN1?30 is safe and highly immunogenic in healthy adult volunteers. Human vaccines. 2006;2(4):167-73.

  63. Durbin AP, Whitehead SS, Shaffer D, Elwood D, Wanionek K, Thumar B, et al. A single dose of the DENV-1 candidate vaccine rDEN1Delta30 is strongly immunogenic and induces resistance to a second dose in a randomized trial. PLoS Negl Trop Dis. 2011;5(8):e1267.

  64. Bancroft W, Scott RM, Eckels K, Hoke C, Simms T, Jesrani K, et al. Dengue virus type 2 vaccine: reactogenicity and immunogenicity in soldiers. Journal of Infectious Diseases. 1984;149(6):1005-10.

  65. Vaughn DW, Hoke CH, Yoksan S, LaChance R, Innis BL, Rice RM, et al. Testing of a dengue 2 live-attenuated vaccine (strain 16681 PDK 53) in ten American volunteers. Vaccine. 1996;14(4):329-36.

  66. Guirakhoo F, Kitchener S, Morrison D, Forrat R, McCarthy K, Nichols R, et al. Live Attenuated Chimeric Yellow Fever Dengue Type 2 (ChimeriVax™-DEN2) Vaccine: Phase I Clinical Trial for Safety and Immunogenicity: Effect of Yellow Fever Pre-immunity in Induction of Cross Neutralizing Antibody Responses to All 4 dengue serotypes. Human vaccines. 2006;2(2):60-7.

  67. Bhamarapravati N, Yoksan S, Chayaniyayothin T, Angsubphakorn S, Bunyaratvej A. Immunization with a live attenuated dengue-2-virus candidate vaccine (16681-PDK 53): clinical, immunological and biological responses in adult volunteers. Bulletin of the World Health Organization. 1987;65(2):189.

  68. Durbin AP, McArthur JH, Marron JA, Blaney JE, Thumar B, Wanionek K, et al. rDEN2/4?30 (ME), a live attenuated chimeric dengue serotype 2 vaccine, is safe and highly immunogenic in healthy dengue-naïve adults. Human vaccines. 2006;2(6):255-60.

  69. Durbin AP, Karron RA, Sun W, Vaughn DW, Reynolds MJ, Perreault JR, et al. Attenuation and immunogenicity in humans of a live dengue virus type-4 vaccine candidate with a 30 nucleotide deletion in its 3'-untranslated region. The American journal of tropical medicine and hygiene. 2001;65(5):405-13.

  70. Durbin AP, Whitehead SS, McArthur J, Perreault JR, Blaney JE, Thumar B, et al. rDEN4delta30, a live attenuated dengue virus type 4 vaccine candidate, is safe, immunogenic, and highly infectious in healthy adult volunteers. Journal of Infectious Diseases. 2005;191(5):710-8.

  71. McArthur JH, Durbin AP, Marron JA, Wanionek KA, Thumar B, Pierro DJ, et al. Phase I clinical evaluation of rDEN4?30-200,201: a live attenuated dengue 4 vaccine candidate designed for decreased hepatotoxicity. The American journal of tropical medicine and hygiene. 2008;79(5):678-84.

  72. Wright PF, Durbin AP, Whitehead SS, Ikizler MR, Henderson S, Blaney JE, et al. Phase 1 trial of the dengue virus type 4 vaccine candidate rDEN4?30-4995 in healthy adult volunteers. The American journal of tropical medicine and hygiene. 2009;81(5):834-41.




2020     |     www.medigraphic.com