Regression of human papillomavirus intraepithelial lesions is induced by MVA E2 therapeutic vaccine

Human Gene Therapy

Volumn 25, Issue 12, 2014, Pages 1035-1049

  Rosales, Ricardo ^a   López Contreras, Mario ^b   Rosales, Carlos ^c   Magallanes Molina, Jose Roberto ^d   Gonzalez Vergara, Roberto ^e   Arroyo Cazarez, Jose Martin ^f   Ricardez Arenas, Antonio ^g   Del Follo Valencia, Armando ^h   Padilla Arriaga, Santiago ⁱ   Guerrero, Miriam Veronica ^j   Pirez, Miguel Angel ^a   Arellano Fiore, Claudia ^a   Villarreal, Freddy ^k  

^a Hospital de Cuautitlan ^*  (Mexico)

^b Hospital de Cuautitlan   (Mexico)

^c UNIVERSIDAD NACIONAL AUTÓNOMA DE MÉXICO   (Mexico)

^d Sanatorio San Francisco   (Mexico)

^e SSA   (Mexico)

^f Hospital Ángeles Xalapa   (Mexico)

^g Hospital Militar   (Mexico)

^h INSTITUTO NACIONAL DE CANCEROLOGÍA   (Mexico)

ⁱ Hospital de la Mujer   (Mexico)

^j HOSPITAL ESPAÑOL DE MÉXICO   (Mexico)

^k CA   (Venezuela)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; MVA E 2 VACCINE; RECOMBINANT VACCINE; TRICHLOROACETIC ACID; UNCLASSIFIED DRUG; VACCINIA VACCINE; VIRUS DNA; WART VIRUS VACCINE; MVA VACCINE; VIRUS VACCINE;

ABDOMINAL PAIN; ADAPTIVE IMMUNITY; ADULT; ANIMAL TISSUE; ANTIBODY TITER; ANUS; ARTHRALGIA; ARTICLE; CELLULAR IMMUNITY; CHILL; COLPOSCOPY; CONDYLOMA; CONTROLLED STUDY; CYTOTOXICITY; DRUG CYTOTOXICITY; DRUG INDUCED HEADACHE; EMBRYO; FEMALE; FEVER; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 31; HUMAN PAPILLOMAVIRUS TYPE 33; HUMAN PAPILLOMAVIRUS TYPE 35; HUMAN PAPILLOMAVIRUS TYPE 45; HUMAN PAPILLOMAVIRUS TYPE 53; HUMAN PAPILLOMAVIRUS TYPE 6; HUMORAL IMMUNITY; INFLUENZA; MAJOR CLINICAL STUDY; MALE; NONHUMAN; PAPILLOMAVIRUS INFECTION; PHASE 3 CLINICAL TRIAL; POLYMERASE CHAIN REACTION; URETHRA; UTERINE CERVIX CARCINOMA IN SITU; UTERUS; VIRUS PARTICLE; VULVA; WART VIRUS; ANIMAL; ANUS NEOPLASMS; CHICK EMBRYO; CLINICAL TRIAL; GENE THERAPY; GENETICS; IMMUNOLOGY; MIDDLE AGED; MULTICENTER STUDY; PAPILLOMAVIRIDAE; PATHOGENICITY; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL; UTERINE CERVICAL NEOPLASMS;

HUMAN PAPILLOMAVIRUS; PAPILLOMAVIRIDAE; VACCINIA VIRUS;

ADULT; ANIMALS; ANUS NEOPLASMS; CHICK EMBRYO; FEMALE; GENETIC THERAPY; HUMANS; MALE; MIDDLE AGED; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS VACCINES; UTERINE CERVICAL NEOPLASMS; VIRAL VACCINES;

EID: 84918815228     PISSN: 10430342     EISSN: 15577422     Source Type: Journal    
DOI: 10.1089/hum.2014.024     Document Type: Article

References (83)

1. Aerssens, A., Claeys, P., Garcia, A., et al. (2008). Natural history and clearance of HPV after treatment of precancerous cervical lesions. Histopathology 52, 381-386
2. Albarran, Y.C.A., de la Garza, A., Cruz Quiroz, B.J., et al. (2007). MVA E2 recombinant vaccine in the treatment of human papillomavirus infection in men presenting intraurethral flat condyloma: a phase I/II study. BioDrugs 21, 47-59
3. Baldwin, P., van der Burg, S., Boswell, C., et al. (2003). Vaccinia-Expressed human papillomavirus 16 and 18 E6 and E7 as a therapeutic vaccination for vulval and vaginal intraepithelial neoplasia. Clin. Cancer Res. 9, 5205-5213
4. Baloglu, A., Uysal, D., Bezircioglu, I., et al. (2010). Residual and recurrent disease rates following LEEP treatment in highgrade cervical intraepithelial lesions. Arch. Gynecol. Obstet. 282, 69-73
5. Best, S.R., Niparko, K.J., and Pai, S.I., (2012). Biology of human papillomavirus infection and immune therapy for HPV-related head and neck cancers. Otolaryngol. Clin. North Am. 45, 807-822
6. Bourgault Villada, I., Moyal Barracco, M., Ziol, M., et al. (2004). Spontaneous regression of grade 3 vulvar intraepithelial neoplasia associated with human papillomavirus-16-specific CD4( + ) and CD8( + ) T-cell responses. Cancer Res. 64, 8761-8766
7. Brun, J.L., Dalstein, V., Leveque, J., et al. (2011). Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy. Am. J. Obstet. Gynecol. 204, 169.e161-e168
8. Cavenaugh, J.S., Awi, D., Mendy, M., et al. (2011). Partially randomized, non-blinded trial of DNA and MVA therapeutic vaccines based on hepatitis B virus surface protein for chronic HBV infection. PLoS One 6, e14626
9. Cebere, I., Dorrell, L., McShane, H., et al. (2006). Phase I clinical trial safety of DNA-And modified virus Ankaravectored human immunodeficiency virus type 1 (HIV-1) vaccines administered alone and in a prime-boost regime to healthy HIV-1-uninfected volunteers. Vaccine 24, 417-425
10. Chen, C.H., Suh, K.W., Ji, H., et al. (2000). Antigen-specific immunotherapy for human papillomavirus 16 E7-expressing tumors grown in the liver. J. Hepatol. 33, 91-98
11. Clifford, G.M., Rana, R.K., Franceschi, S., et al. (2005). Human papillomavirus genotype distribution in low-grade cervical lesions: comparison by geographic region and with cervical cancer. Cancer Epidemiol. Biomarkers Prev. 14, 1157-1164
12. Corona-Gutierrez, C., Tinoco, A., Contreras, M., et al. (2002). A phase II study. Efficacy of the gene therapy of the MVA E2 recombinant virus in the treatment of precancerous lesions (NIC I and NIC II) associated with infection of oncogenic human papillomavirus. Hum. Gene Ther. 13, 1127-1140
13. Corona-Gutierrez, C., Tinoco, A., Navarro, T., et al. (2004). Therapeutic vaccination with MVA E2 can eliminate precancerous lesions (CIN 1, CIN 2 and CIN 3) associated with infection by oncogenic human papillomavirus. Hum. Gene Ther. 15, 421-431
14. Cosma, A., Nagaraj, R., Buhler, S., et al. (2003). Therapeutic vaccination with MVA-HIV-1 nef elicits Nef-specific T-helper cell responses in chronically HIV-1 infected individuals. Vaccine 22, 21-29
15. Cottingham, M.G., and Carroll, M.W. (2013). Recombinant MVA vaccines: dispelling the myths. Vaccine 31, 4247-4251
16. Cuburu, N., Graham, B.S., Buck, C.B., et al. (2012). Intravaginal immunization with HPV vectors induces tissue-resident CD8 + T cell responses. J. Clin. Invest. 122, 4606-4620
17. Currier, J.R., Ngauy, V., de Souza, M.S., et al. (2010). Phase I safety and immunogenicity evaluation of MVA-CMDR, a multigenic, recombinant modified vaccinia Ankara-HIV-1 vaccine candidate. PLoS One 5, e13983
18. Cuzick, J., Meijer, C., and Walboomers, J. (1998). Screening for cervical cancer. Lancet 351, 1439-1440
19. Cuzick, J., Bergeron, C., von Knebel Doeberitz, M., et al. (2012). New technologies and procedures for cervical cancer screening. Vaccine 30 Suppl 5, F107-F116
20. Davidson, E.J., Boswell, C.M., Sehr, P., et al. (2003). Immunological and clinical responses in women with vulval intraepithelial neoplasia vaccinated with a vaccinia virus encoding human papillomavirus 16/18 oncoproteins. Cancer Res. 63, 6032-6041
21. de Jong, A., van Poelgeest, M.I., van der Hulst, J.M., et al. (2004). Human papillomavirus type 16-positive cervical cancer is associated with impaired CD4 + T-cell immunity against early antigens E2 and E6. Cancer Res. 64, 5449-5455
22. de Sanjose, S., Diaz, M., Castellsague, X., et al. (2007). Worldwide prevalence and genotype distribution of cervical human papillomavirus DNA in women with normal cytology: a meta-Analysis. Lancet Infect. Dis. 7, 453-459
23. Desaintes, C., Demeret, C., Goyat, S., et al. (1997). Expression of the papillomavirus E2 protein in HeLa cells leads to apoptosis. EMBO J. 16, 504-514
24. Dillner, J., Arbyn, M., Unger, E., and Dillner, L. (2011). Monitoring of human papillomavirus vaccination. Clin. Exp. Immunol. 163, 17-25
25. Doorbar, J. (2013). Latent papillomavirus infections and their regulation. Curr. Opin. Virol. 3, 416-421
26. Doorbar, J., Quint, W., Banks, L., et al. (2012). The biology and life-cycle of human papillomaviruses. Vaccine 30 Suppl 5, F55-F70
27. Dorrell, L., Williams, P., Suttill, A., et al (2007). Safety and tolerability of recombinant modified vaccinia virus Ankara expressing an HIV-1 gag/multiepitope immunogen (MVA HIVA) in HIV-1-infected persons receiving combination antiretroviral therapy. Vaccine 25, 3277-3283
28. Draper, E., Bissett, S.L., Howell-Jones, R., et al. (2013). A randomized, observer-blinded immunogenicity trial of Cervarix((R)) and Gardasil((R)) human papillomavirus vaccines in 12-15 year old girls. PLoS One 8, e61825
29. Earl, P.L., Cooper, N., Wyatt, L.S., et al. (2001). Preparation of cell cultures and vaccinia virus stocks. In Current Protocols in Protein Science. J.E. Coligan, et al. eds. (John Wiley and Sons, Inc., Hoboken, NJ) Chapter 5, Unit 5.12
30. Garcia, F., Petry, K.U., Muderspach, L., et al. (2004). ZYC101a for treatment of high-grade cervical intraepithelial neoplasia: a randomized controlled trial. Obstet. Gynecol. 103, 317-326
31. Garcia, F., Bernaldo de Quiros, J.C., Gomez, C.E., et al. (2011). Safety and immunogenicity of a modified pox vector-based HIV/AIDS vaccine candidate expressing Env, Gag, Pol and Nef proteins of HIV-1 subtype B (MVA-B) in healthy HIV-1-uninfected volunteers: a phase I clinical trial (RISVAC02). Vaccine 29, 8309-8316
32. Garcia-Hernandez, E., Gonzalez-Sanchez, J.L., Andrade-Manzano, A., et al. (2006). Regression of papilloma highgrade lesions (CIN 2 and CIN 3) is stimulated by therapeutic vaccination with MVA E2 recombinant vaccine. Cancer Gene Ther. 13, 592-597
33. Ghosh, P., Ghosh, D.D., Majumdar Giri, A., et al. (2014). Polymerase chain reaction and deoxyribonucleic acid-sequencing based study on distribution of human papillomavirus 16/18 among histopathological types of cervical intra-epithelial neoplasia and primary invasive cervical carcinoma: a scenario in North Bengal, India. J. Midlife Health 5, 14-22
34. Gilbert, S.C. (2013). Clinical development of modified vaccinia virus Ankara vaccines. Vaccine 31, 4241-4246
35. Goepfert, P.A., Elizaga, M.L., Sato, A., et al. (2011). Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 viruslike particles. J. Infect. Dis. 203, 610-619
36. Hakim, A.A., and Dinh, T.A. (2009). Worldwide impact of the human papillomavirus vaccine. Curr. Treat. Options Oncol. 10, 44-53
37. Hall, H., Teuscher, C., Urie, P., et al. (1994). Induced regression of bovine papillomas by intralesional immunotherapy. Ther. Immunol. 1, 319-324
38. Harper, D.M., Franco, E.L., Wheeler, C.M., et al. (2006). Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet 367, 1247-1255
39. Ho, G.Y., Bierman, R., Beardsley, L., et al. (1998). Natural history of cervicovaginal papillomavirus infection in young women. N. Engl. J. Med. 338, 423-428
40. Hossein, R., Behzad, S., Tahar, M., and Azadeh, N.A. (2013). Prevalence of human papillomavirus genotypes associated with cervical and breast cancers in iran. Monoclonal Antibodies Immunodiag. Immunother. 32, 399-403
41. Iborra, S., Izquierdo, H.M., Martinez-Lopez, M., et al. (2012). The DC receptor DNGR-1 mediates cross-priming of CTLs during vaccinia virus infection in mice. J. Clin. Invest. 122, 1628-1643
42. National Cancer Institute (2010) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Available at http://evs.nci.gov/ftp1/CTCAE-4.03-2010-06-14-QuickReference-5x7.pdf (accessed 2011
43. Jaoko, W., Nakwagala, F.N., Anzala, O., et al. (2008). Safety and immunogenicity of recombinant low-dosage HIV-1A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa. Vaccine 26, 2788-2795
44. Jemal, A., Bray, F., Center, M.M., et al. (2011). Global cancer statistics. CA 61, 69-90
45. Kaufmann, A.M., Stern, P.L., Rankin, E.M., et al. (2002). Safety and immunogenicity of TA-HPV, a recombinant vaccinia virus expressing modified human papillomavirus (HPV)-16 and HPV-18 E6 and E7 genes, in women with progressive cervical cancer. Clin. Cancer Res. 8, 3676-3685
46. Lacey, C.J., Woodhall, S.C., Wikstrom, A., and Ross, J. (2013). 2012 European guideline for the management of anogenital warts. J. Eur. Acad. Dermatol. Venereol. 27, e263-e270
47. Lee, S.Y., Kang, T.H., Knoff, J., et al. (2013). Intratumoral injection of therapeutic HPV vaccinia vaccine following cisplatin enhances HPV-specific antitumor effects. Cancer Immunol. Immunother. 62, 1175-1185
48. Lescaille, G., Pitoiset, F., Macedo, R., et al. (2013). Efficacy of DNA vaccines forming e7 recombinant retroviral virus-like particles for the treatment of human papillomavirus-induced cancers. Hum. Gene Ther. 24, 533-544
49. Marabelle, A., Kohrt, H., Caux, C., and Levy, R. (2014). Intratumoral immunization: a new paradigm for cancer therapy. Clin. Cancer Res. 20, 1747-1756
50. Markowitz, L.E., Tsu, V., Deeks, S.L., et al. (2012). Human papillomavirus vaccine introduction-The first five years. Vaccine 30 Suppl 5, F139-F148
51. Martin-Hirsch, P.P., Paraskevaidis, E., Bryant, A., et al. (2010). Surgery for cervical intraepithelial neoplasia. Cochrane Database Syst. Rev. CD001318
52. Maw, R. (2004). Critical appraisal of commonly used treatment for genital warts. Int. J. STD AIDS 15, 357-364
53. McLaughlin-Drubin, M.E., Meyers, J., and Munger, K. (2012). Cancer associated human papillomaviruses. Curr. Opin. Virol. 2, 459-466
54. Mun'oz, N., Kato, I., Bosch, F.X., et al. (1996). Risk factors for HPV DNA detection in middle-Aged women. Sex. Transm. Dis. 23, 504-510
55. NCBI/BLAST. Available at: www.ncbi.nlm.nih.gov/blast (accessed October 17, 2014
56. Nelson, E.A., Lam, H.S., Choi, K.C., et al. (2013). A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18-26 years. Vaccine 31, 3452-3460
57. Nuovo, G.J., and Richart, R.M. (1990). Human papillomavirus DNA in situ hybridization may be used for the quality control of genital tract biopsies. Obstet. Gynecol. 75, 223-226
58. Nuovo, G.J., Friedman, D., and Richart, R.M. (1990). In situ hybridization analysis of human papillomavirus DNA segregation patterns in lesions of the female genital tract. Gynecol. Oncol. 36, 256-262
59. Ogwang, C., Afolabi, M., Kimani, D., et al. (2013). Safety and immunogenicity of heterologous prime-boost immunisation with Plasmodium falciparum malaria candidate vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, in healthy Gambian and Kenyan adults. PLoS One 8, e57726
60. Paavonen, J., Naud, P., Salmeron, J., et al. (2009). Efficacy of human papillomavirus (HPV)-16/18 AS04-Adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 374, 301-314
61. Pandhi, D., and Sonthalia, S. (2011). Human papilloma virus vaccines: current scenario. Indian J. Sex. Transm. Dis. 32, 75-85
62. Poljak, M., Cuzick, J., Kocjan, B.J., et al. (2012). Nucleic acid tests for the detection of alpha human papillomaviruses. Vaccine 30 Suppl 5, F100-F106
63. Powell, N., Cuschieri, K., Cubie, H., et al. (2013). Cervical cancers associated with human papillomavirus types 16, 18 and 45 are diagnosed in younger women than cancers associated with other types: a cross-sectional observational study in Wales and Scotland (UK). J. Clin. Virol. 58, 571-574
64. Rahman, T., Tabassum, S., Jahan, M., et al. (2013). Detection and estimation of human papillomavirus viral load in patients with cervical lesions. Bangladesh Med. Res. Council Bull. 39, 86-90
65. Rosales, R., and Rosales, C. (2014). Immune therapy for human papillomavirus-related cancers. World J. Clin. Oncol. In press
66. Rosales, C., Valadez, G., Arrellin, R., et al. (2000). A recombinant vaccinia virus containing the papilloma E2 protein promotes tumor regression by stimulating macrophage antibody-dependent cytotoxicity. Cancer Immunol. Immunother. 49, 347-360
67. Santana, V.C., Diniz, M.O., Cariri, F.A., et al. (2013). Bicistronic DNA vaccines simultaneously encoding HIV, HSV and HPV antigens promote CD8( + ) T cell responses and protective immunity. PLoS One 8, e71322
68. Sheehy, S.H., Duncan, C.J., Elias, S.C., et al. (2012). Phase Ia clinical evaluation of the safety and immunogenicity of the Plasmodium falciparum blood-stage antigen AMA1 in ChAd63 and MVA vaccine vectors. PLoS One 7, e31208
69. Smith, J.S., Lindsay, L., Hoots, B., et al. (2007). Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-Analysis update. International journal of cancer. J. Int. Cancer 121, 621-632
70. Sonnex, C., and Lacey, C.J. (2001). The treatment of human papillomavirus lesions of the lower genital tract. Best practice& research. Clin. Obstet. Gynaecol. 15, 801-816
71. Stanley, M.A. (2002). Prognostic factors and new therapeutic approaches to cervical cancer. Virus Res. 89, 241-248
72. Su, J.H., Wu, A., Scotney, E., et al. (2010). Immunotherapy for cervical cancer: research status and clinical potential. Bio-Drugs 24, 109-129
73. Tomljenovic, L., and Shaw, C.A. (2013). Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds? Ann. Med. 45, 182-193
74. Trimble, C.L., Peng, S., Kos, F., et al. (2009). A phase I trial of a human papillomavirus DNA vaccine for HPV16 + cervical intraepithelial neoplasia 2/3. Clin. Cancer Res. 15, 361-367
75. U.S. FDA (2003). Current Good Manufacturing Practices (CGMPs). Available at www.fda.gov/drugs/guidancecompliance regulatoryinformation/guidance/ucm064971.htm (accessed August 10, 2014
76. Valadez, G., Sutter, G., Jose, M., et al. (2000). Human tumor growth is inhibited by vaccinia virus carrying the E2 gene of bovine papillomavirus. Cancer 88, 1650
77. van der Burg, S.H., Ressing, M.E., Kwappnberg, K.M.C., et al. (2001). Natural T-helper immunity against human papillomavirus type 16(HPV16)-derived peptide epitopes in patients with HPV 16-positive cervical lesions. identification of 3 human leukocyte antigen class II-restricted epitopes. Int. J. Cancer 91, 612-618
78. Verheust, C., Goossens, M., Pauwels, K., and Breyer, D. (2012). Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination. Vaccine 30, 2623-2632
79. Villa, L.L., Costa, R.L., Petta, C.A., et al. (2006). High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br. J. Cancer 95, 1459-1466
80. Walsh, J.M. (1998). Cervical cancer: developments in screening and evaluation of the abnormal Pap smear. West. J. Med. 169, 304-310
81. Welters, M.J., de Jong, A., van den Eeden, S.J., et al. (2003). Frequent display of human papillomavirus type 16 E6-specific memory t-Helper cells in the healthy population as witness of previous viral encounter. Cancer Res. 63, 636-641
82. Wilck, M.B., Seaman, M.S., Baden, L.R., et al. (2010). Safety and immunogenicity of modified vaccinia Ankara (ACAM3000): effect of dose and route of administration. J. Infect. Dis. 201, 1361-1370
83. Woodman, C.B., Collins, S.I., and Young, L.S. (2007). The natural history of cervical HPV infection: unresolved issues. Nat. Rev. Cancer 7, 11-22