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2021, Número 1

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MEDICC Review 2021; 23 (1)


Cuban Prophylactic and Therapeutic Vaccines for Controlling Hepatitis B

Pentón-Arias E, Aguilar-Rubido JC

Idioma: Ingles.
Referencias bibliográficas: 51
Paginas: 21-29
Archivo PDF: 691.92 Kb.


RESUMEN

Sin resumen.


REFERENCIAS (EN ESTE ARTÍCULO)

  1. Betancourt AA, González Delgado CA, Estévez ZC, Martínez JC, Ríos GV, Moreno Aureoles- Roselló SR, et al. Phase I in healthy adults of a nasal vaccine candidate containing recombinant hepatitis B surface and core antigens. Int J Infect Dis. 2007 Sep;11(5):394–401.

  2. Fernández G, Sánchez AL, Jerez E, Anillo LE, Freyre F, AguiarJA, et al. Five-year follow-up of chronic hepatitis B patients immunized by nasal route with the therapeutic vaccine HeberNasvac. Euroasian J Hepato-Gastroenterol. 2018 Jul –Dec;8(2):133–9.

  3. Al-Mahtab M, Akbar SMF, Aguilar JC, Uddin MH, Khan MSI, Rahman S. Therapeutic potential of a combined hepatitis B virus surface and core antigen vaccine in patients with chronic hepatitis B. Hepatol Int. 2013 Oct;7(4):981–9.

  4. Al Mahtab M, Akbar SMF, Aguilar JC, Guillén G, Pentón E, Tuero A, et al. Treatment of chronic hepatitis B naïve patients with a therapeutic vaccine containing HBs and HBc antigens (a randomized, open and treatment controlled phase III). PLoS One. 2018 Aug 22;13(8):e0201236.

  5. Global Hepatitis Report 2017 [Internet]. Geneva: World Health Organization; 2017 Apr [cited 2020 Nov 2]. 83 p. Available at: https://www .who.int/hepatitis/publications/global-hepatitis -report2017/en/

  6. Torres Vidal RM, Galindo Sardiña MA, Valcárcel Sánchez M. Enfermedades prevenibles por vacunas. Morbilidad y mortalidad. In: Rojas Ochoa F, editor. Vacunas. Cuba.1959-2008 [Internet]. Havana: ECIMED; 2011 [cited 2020 Nov 2]. p. 43. Available at: http://www.bvscuba.sld.cu/libro/ vacunas-cuba-1959-2008/. Spanish.

  7. Muzio V, Quiñones Y, Quintana M. Vacuna cubana contra la hepatitis B. Impacto de un producto biotecnológico en la salud pública. In: Rojas Ochoa F. Vacunas. Cuba.1959-2008 [Internet]. Havana: ECIMED; 2011 [cited 2020 Nov 27]. p. 134. Available at: http://www.bvscuba.sld.cu/ libro/vacunas-cuba-1959-2008/. Spanish.

  8. Reed G, Galindo MA. Cuba’s National Immunization Program. MEDICC Rev. 2007 Oct;9(1):5–7.

  9. López Ambrón L, Egües Torres LI, Pérez Carreras A, Galindo Santana BM, Galindo Sardiña MA, Resik Aguirre S, et al. Experiencia cubana en inmunización, 1962–2016. Rev Panam Salud Pública. 2018 Apr 24;42:e34. DOI: 10.26633/ RPSP.2018.34. Spanish.

  10. Cuba’s biotech boom. Nature. 2009 Jan 8;457(7226):130. DOI: https://doi.org/10.1038/45 7130a

  11. Center for State Control of Medicines and Medical Devices (CECMED) [Internet]. Havana: Ministry of Public Health (CU); c2020. Registro. RCP. HEBERBIOVAC HB® . (VACUNA ANTIHEPATITIS B RECOMBINANTE); 2017 [cited 2020 Nov 27]. 5 p. Available at: https://www.cecmed.cu/re gistro/rcp/heberpentar-l-vacuna-pentavalente-liqui da-difteria-tetanos-tos-ferina-hepatitis-b. Spanish.

  12. Hardy E, Martínez E, Diago D, Díaz R, González D, Herrera L. Large-scale production of recombinant hepatitis B surface antigen from Pichia pastoris. J Biotechnol. 2000 Feb 17;77(2–3):157–67.

  13. Agraz A, Quiñones Y, Expósito N, Breña F, Madruga J, Pentón E. Adsorption-desorption of recombinant hepatitis B surface antigen (r-HBsAg) from P. pastoris on a diatomaceous earth matrix: Optimization of parameters for purifi cation. Biotechnol Bioeng. 1993 Nov 20;42(10):1238–44.

  14. Center for State Control of Medicines and Medical Devices (CECMED) [Internet]. Havana: Ministry of Public Health (CU); c2020. Registro. RCP. Heberpenta®-L (Vacuna pentavalente líquida contra la difteria, tétanos, tos ferina, hepatitis B y Haemophilus infl uenzae tipo b); [cited 2020 Nov 27]. 6 p. Available at: https://www.cecmed.cu/ registro/rcp/heberpentar-l-vacuna-pentavalente -liquida-difteria-tetanos-tos-ferina-hepatitis-b. Spanish.

  15. Center for State Control Medicines and Medical Devices (CECMED) [Internet]. Havana: Ministry of Public Health (CU); c2020. Registro. RCP. HeberNasvac® (Vacuna terapéutica recombinante contra la hepatitis B); [cited 2020 Nov 27]. 6 p. Available at: https://www.cecmed.cu/registro/ rcp/hebernasvacr-vacuna-terapeutica-recomb inante-hepatitis-b. Spanish.

  16. Iglesias E, García D, Carrazana Y, Aguilar JC, Sánchez A, Gorobaya L, et al. Anti-HIV-1 and anti-HBV immune responses in mice after parenteral and nasal co-administration of a multiantigenic formulation. Curr HIV Res. 2008 Sep;6(5):452–60.

  17. Iglesias E, Thompson R, Carrazana Y, Lobaina Y, García D, Sánchez J, et al. Co-inoculation with hepatitis B surface and core antigen promotes a Th1 immune response to a multiepitopic protein of HIV-1. Immunol Cell Biol. 2006 Apr;84(2):174–83.

  18. Bello Corredor M, Díaz González M, Heng Hung Ricardo L, Delgado González G, Montalvo Villalba MC, et al. Marcadores serológicos en lactantes de alto y bajo riesgo de infección por el virus de la hepatitis B inmunizados con una vacuna recombinante cubana. Paediatrica. 2006;8(1):7–14. Spanish.

  19. Muzio González V, Cinza Estévez Z, Ortega Tápanes A, Véliz Ríos G, Galindo MA, Delgado G, et al. Estudios postlicenciamiento de la vacuna cubana contra la hepatitis B, Heberbiovac HB. Biotecnol Aplic. 2001 Apr;18(2):103–4. Spanish.

  20. Ramírez Albajéz V, González Griego A, Alerm González A, Vega García I, Pentón Arias E, González Griego M. Seguridad e inmunogenicidad de la vacuna cubana Heberbiovac HB en poblaciones de América, Europa, Africa y Asia. Rev Cubana Invest Bioméd. 2000 Jan– Apr;19(1):28–33. Spanish.

  21. Zumaeta E, González Griego A, Ferrandiz J, Villanueva A, Soto V, Almeida R, et al. Pronóstico de duración de títulos protectores anti-HBs ag en trabajadores de la salud del Perú luego de 6 años de vacunados. Rev Gastroenterol Perú [Internet]. 2001 Oct–Dec [cited 2020 Nov 29];21(4):276–81. Available at: http://www.scielo .org.pe/scielo.php?script=sci_arttext&pid=S1022 -51292001000400004&lng=es. Spanish.

  22. Bello Corredor M, Rodríguez Lay LA, Rodríguez Argueta D, Montalvo Villalba MC, Pedroso Flaquet P, Sariego Frómeta S, et al. Infección oculta por el virus de la hepatitis B en hijos de madres positivas al HBsAg. VacciMonitor. 2016 Jan –Apr;25(1):1–6. Spanish.

  23. Rodríguez Lay LA, Bello Corredor M, Montalvo Villalba MC, Chibás Ojeda AG, Sariego Frómeta S, Díaz González M, et al. Hepatitis B virus infection assessed 3 to 18 years after vaccination in Cuban children and adolescents born to HBsAg-positive mothers. Arch Virol. 2017 Aug;162(8):2393–6.

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  25. Michel ML, Deng Q, Mancini-Bourgine M. Therapeutic vaccines and immune-based therapies for the treatment of chronic hepatitis B: perspectives and challenges. J Hepatol. 2011 Jun;54(6):1286 –96.

  26. Verna EC. Updated Hepatitis B guidance: implications for liver transplant patients. Liver Transpl. 2018 Apr;24(4):465–9.

  27. Center for State Control Medicines and Medical Devices (CECMED) [Internet]. Havana: Ministry of Public Health (CU); c2020. Registro. RCP. PEG-Heberon® (Interferón alfa 2b hu-rec conjugado a polietilenglicol); [cited 2020 Nov 30]. 8 p. Available at: https://www.cecmed.cu/registro/rcp/ peg-heberonr-interferon-alfa-2b-hu-rec-conjuga do-polietilenglicol. Spanish.

  28. Shamliyan TA, MacDonald R, Shaukat A, Taylor BC, Yuan JM, Johnson JR, et al. Antiviral therapy for adults with chronic hepatitis B: a systematic review for a National Institutes of Health Consensus Development Conference. Ann Intern Med. 2009 Jan 20;150(2):111–24.

  29. Lin CL, Kao JH. Recent advances in the treatment of chronic hepatitis B. Expert Opin Pharmacother. 2011 Sep;12(13):2025–40.

  30. Scaglione SJ, Lok ASF. Effectiveness of hepatitis B treatment in clinical practice. Gastroenterology. 2012 May;142(6):1360–8.

  31. Aguilar Rubido JC, Palenzuela Gardón DO, Muzio González VL, Guillén Nieto GE, Pentón Arias E, Pichardo Díaz D, et al, inventors; Center for Genetic Engineering and Biotechnology (CIGB), assignee. WO2000032229 A1 Preparations containing virus-like particles as immunopotentiators administered through the mucosa. Cuba patent CU PCT/CU1999/000006. 2008 Jun 6.

  32. Aguilar Rubido JC, Pentón Arias E, Tleugabulova D, Sewer Mensies M, Muzio González VL, Guillén Nieto GE, et al, inventors; Center for Genetic Engineering and Biotechnology (CIGB), assignee. WO2002043756 A2 Method for obtaining antigenic aggregates and the use thereof in formulations. Cuba patent CU PCT/ CU2001/000009. 2002 Jun 6.

  33. Aguilar Rubido JC, Lobaina Mato Y, Iglesias Pérez E, Pentón Arias E, Guillén Nieto GE, Aguiar Santiago JA, et al, inventors; Center for Genetic Engineering and Biotechnology (CIGB), assignee. WO2017167317 A1 Pharmaceutical composition that includes the surface and nucleocapsid antigens of the hepatitis B virus. Cuba patent CU PCT/CU2017/050001. 2017 Oct 5.

  34. Aguilar JC, Lobaina Y, Muzio V, García D, Pentón E, Iglesias E, et al. Development of a nasal vaccine for chronic hepatitis B infection that uses the ability of hepatitis B core antigen to stimulate a strong Th1 response against hepatitis B surface antigen. Immunol Cell Biol. 2004 Oct;82(5):539–46.

  35. Vandepapelière P, Lau GKK, Leroux-Roels G, Horsmans Y, Gane E, Tawandee T, et al. Therapeutic HBV Vaccine Group of Investigators. Therapeutic vaccination of chronic hepatitis B patients with virus suppression by antiviral therapy: a randomized, controlled study of co-administration of HBsAg/AS02 candidate vaccine and lamivudine. Vaccine. 2007 Dec 12;25(51):8585–97.

  36. Lau GK, Suri D, Liang R, Rigopoulou EI, Thomas MG, Mullerova I, et al. Resolution of chronic hepatitis B and anti-HBs seroconversion in humans by adoptive transfer of immunity to hepatitis B core antigen. Gastroenterology. 2002 Mar;122(3):614–24.

  37. Aguilar JC, Lobaina Y. Immunotherapy for chronic hepatitis B using HBsAg-based vaccine formulations: from preventive commercial vaccines to therapeutic approach. Euroasian J Hepatogastroenterol. 2014 Jul–Dec;4(2):92–7.

  38. Bourgine M, Crabe S, Lobaina Y, Guillén G, Aguilar JC, Michel ML. Nasal route favors the induction of CD4(+) T cell responses in the liver of HBV-carrier mice immunized with a recombinant hepatitis B surface- and core-based therapeutic vaccine. Antiviral Res. 2018 May;153:23–32.

  39. Mancini-Bourgine M, Guillén G, Michel ML, Aguilar JC. Impact of the immunogen nature on the immune response against the major HBV antigens in an HBsAg and HLA-humanized transgenic mouse model. Euroasian J Hepatogastroenterol. 2014 Jan–Jun;4(1):36–44.

  40. Bourgine M, Dion S, Godon O, Guillén G, Michel ML, Aguilar JC. Optimization of immune respons-es induced by therapeutic vaccination with crossreactive antigens in a humanized hepatitis B surface antigen transgenic mouse model. Virology. 2012 Aug 15;430(1):10–9.

  41. Trujillo H, Blanco A, García D, Freyre F, Aguiar J, Lobaina Y, et al. Optimization of a therapeutic vaccine candidate by studying routes, immunization schedules and antigen doses in HBsAg-positive transgenic mice. Euroasian J Hepatogastroenterol. 2014 Jul–Dec;4(2):70–8.

  42. Akbar SMF, Yoshida O, Chen S, Aguilar JC, Abe M, Matsuura B, et al. Immune modulator and antiviral potential of dendritic cells pulsed with both hepatitis B surface antigen and core antigen for treating chronic HBV infection. Antivir Ther. 2010;15(6):887–95.

  43. Akbar SMF, Chen S, Al-Mahtab M, Abe M, Hiasa Y, Onji M. Strong and multi-antigen specifi c immunity by hepatitis B core antigen (HBcAg)- based vaccines in a murine model of chronic hepatitis B: HBcAg is a candidate for a therapeutic vaccine against hepatitis B virus. Antiviral Res. 2012 Oct;96(1):59–64.

  44. Porras DN, Cosme K, Aldana L, Bacardí D, Merino N, Milá L, et al. Determination and assessment of the irritant potential of a nasal vaccine candidate, which combines Hepatitis B surface antigen and Hepatitis B core antigen. Biotecnol Aplic. 2004 Jan;21(3):143–7.

  45. Lobaina Mato Y, Aguilar Rubido JC, Guillén Nieto G. ABX203, a novel therapeutic vaccine for chronic hepatitis B patients. Almanac Clin Med. 2016 Sep;44(6):713–8.

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  50. Yoshida O, Imai Y, Akbar SMF, Kohara M, Kohara K, Miyazak T, et al. A nasal administrative therapeutic vaccine (NASVAC) with modifi ed treatment strategy reduces and eliminates HBs antigen in HBV infected patients with or without nucleos(t)ide analogs therapy. AASLD Abstracts. Hepatology. 2018;68(1).

  51. Wedemeyer H, Hui AJ, Sukeepaisarnjaroen W, Tangkijvanich P, Guillén G, Gineste P, et al. Therapeutic vaccination of chronic hepatitis B patients with ABX203 (NASVAC) to prevent relapse after stopping NAs: contrasting timing rebound between tenofovir and entecavir. J Hepatol. 2017 Dec; 66:S101.




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