A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16 + cervical intraepithelial neoplasia 2/3 (CIN2/3)

Gynecologic Oncology

Volumn 140, Issue 2, 2016, Pages 245-252

  Alvarez, Ronald D ^a   Huh, Warner K ^a   Bae, Sejong ^a   Lamb, Lawrence S ^a   Conner, Michael G ^a   Boyer, Jean ^b   Wang, Chenguang ^c   Hung, Chien Fu ^c   Sauter, Elizabeth ^c   Paradis, Mihaela ^c   Adams, Emily A ^c   Hester, Shirley ^a   Jackson, Bradford E ^a   Wu, T C ^c   Trimble, Cornelia L ^c  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Cervical dysplasia; Therapeutic DNA vaccine

Indexed keywords

CANCER VACCINE; DNA VACCINE; PNGVL4A CRT E7 VACCINE; UNCLASSIFIED DRUG; WART VIRUS VACCINE;

ABDOMINAL DISCOMFORT; ADULT; ARTHRALGIA; ARTICLE; CANCER IMMUNIZATION; CANCER PATIENT; CD8+ T LYMPHOCYTE; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; COHORT ANALYSIS; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; FATIGUE; FEASIBILITY STUDY; FEMALE; FLU LIKE SYNDROME; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN TISSUE; IMMUNE RESPONSE; IMMUNOGENICITY; INJECTION SITE CONTUSION; INJECTION SITE DISCOLORATION; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; LARYNGEAL INFLAMMATION; LARYNX DISORDER; LYMPHOCYTIC INFILTRATION; MALAISE; MUSCLE CRAMP; MYALGIA; NAUSEA; PAPILLOMAVIRUS INFECTION; PARESTHESIA; PATIENT SAFETY; PILOT STUDY; PRIORITY JOURNAL; SPOTTING; UTERINE CERVIX CARCINOMA IN SITU; VAGINA BLEEDING; VIRUS LOAD; CERVICAL INTRAEPITHELIAL NEOPLASIA; CLINICAL TRIAL; DOSE RESPONSE; IMMUNOLOGY; ISOLATION AND PURIFICATION; PAPILLOMAVIRUS INFECTIONS; PATHOLOGY; UTERINE CERVICAL NEOPLASMS; VIROLOGY; YOUNG ADULT;

ADULT; CD8-POSITIVE T-LYMPHOCYTES; CERVICAL INTRAEPITHELIAL NEOPLASIA; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; FEMALE; HUMAN PAPILLOMAVIRUS 16; HUMANS; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; PILOT PROJECTS; UTERINE CERVICAL NEOPLASMS; VACCINES, DNA; VIRAL LOAD; YOUNG ADULT;

EID: 84961825408     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2015.11.026     Document Type: Article

References (32)

1. N.P. Tran, C.F. Hung, R. Roden, and T.C. Wu Control of HPV infection and related cancer through vaccination. Recent results in cancer research Fortschritte der Krebsforschung Progres dans les recherches sur le cancer 193 2014 149 171
2. C. Dochez, J.J. Bogers, R. Verhelst, and H. Rees HPV vaccines to prevent cervical cancer and genital warts: an update Vaccine 32 2014 1595 1601
3. A. Jemal, E.P. Simard, C. Dorell, and et al. Annual report to the nation on the status of cancer, 1975-2009, featuring the burden and trends in human papillomavirus(HPV)-associated cancers and HPV vaccination coverage levels J. Natl. Cancer Inst. 105 2013 175 201
4. A. Heinonen, M. Gissler, A. Riska, J. Paavonen, A.M. Tapper, and M. Jakobsson Loop electrosurgical excision procedure and the risk for preterm delivery Obstet. Gynecol. 121 2013 1063 1068
5. S. Vinokurova, N. Wentzensen, I. Kraus, and et al. Type-dependent integration frequency of human papillomavirus genomes in cervical lesions Cancer Res. 68 2008 307 313
6. N. Hafner, C. Driesch, M. Gajda, and et al. Integration of the HPV16 genome does not invariably result in high levels of viral oncogene transcripts Oncogene 27 2008 1610 1617
7. J.B. Hudson, M.A. Bedell, D.J. McCance, and L.A. Laiminis Immortalization and altered differentiation of human keratinocytes in vitro by the E6 and E7 open reading frames of human papillomavirus type 18 J. Virol. 64 1990 519 526
8. B.A. Werness, H.A. Levine, and P.M. Howley Association of human papillomavirus types 16 and 18 E6 proteins with p53 Science 248 1990 76 79
9. W.F. Cheng, C.F. Hung, C.Y. Chai, and et al. Tumor-specific immunity and antiangiogenesis generated by a DNA vaccine encoding calreticulin linked to a tumor antigen J. Clin. Invest. 108 2001 669 678
10. P.E. Gravitt, C. Peyton, C. Wheeler, R. Apple, R. Higuchi, and K.V. Shah Reproducibility of HPV 16 and HPV 18 viral load quantitation using TaqMan real-time PCR assays J. Virol. Methods 112 2003 23 33
11. L.K. Roberts, L.J. Barr, D.H. Fuller, C.W. McMahon, P.T. Leese, and S. Jones Clinical safety and efficacy of a powdered hepatitis B nucleic acid vaccine delivered to the epidermis by a commercial prototype device Vaccine 23 40 2005 4867 4878
12. J.D. Boyer, T.M. Robinson, M.A. Kutzler, and et al. SIV DNA vaccine co-administered with IL-12 expression plasmid enhances CD8 SIV cellular immune responses in cynomolgus macaques J. Med. Primatol. 34 2005 262 270
13. S. Janetzki, K.S. Panageas, L. Ben-Porat, and et al. Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI) Cancer Immunol. Immunother. 57 2008 303 315
14. J. Yan, D.K. Reichenbach, N. Corbitt, and et al. Induction of antitumor immunity in vivo following delivery of a novel HPV-16 DNA vaccine encoding an E6/E7 fusion antigen Vaccine 27 2009 431 440
15. J. Yan, K. Harris, A.S. Khan, R. Draghia-Akli, D. Sewell, and D.B. Weiner Cellular immunity induced by a novel HPV18 DNA vaccine encoding an E6/E7 fusion consensus protein in mice and rhesus macaques Vaccine 26 2008 5210 5215
16. L. Maldonado, J.E. Teague, M.P. Morrow, and et al. Intramuscular therapeutic vaccination targeting HPV16 induces T cell responses that localize in mucosal lesions Sci. Trans. Med. 6 2014 221ra13
17. E.E. Sheets, R.G. Urban, C.P. Crum, and et al. Immunotherapy of human cervical high-grade cervical intraepithelial neoplasia with microparticle-delivered human papillomavirus 16 E7 plasmid DNA Am. J. Obstet. Gynecol. 188 2003 916 926
18. F. Garcia, K.U. Petry, L. Muderspach, and et al. ZYC101a for treatment of high-grade cervical intraepithelial neoplasia: a randomized controlled trial Obstet. Gynecol. 103 2004 317 326
19. M. Matijevic, M.L. Hedley, R.G. Urban, R.M. Chicz, C. Lajoie, and T.M. Luby Immunization with a poly (lactide co-glycolide) encapsulated plasmid DNA expressing antigenic regions of HPV 16 and 18 results in an increase in the precursor frequency of T cells that respond to epitopes from HPV 16, 18, 6 and 11 Cell. Immunol. 270 2011 62 69
20. Bodles-Brakhop AM, Heller R, Draghia-Akli R. Electroporation for the delivery of DNA-based vaccines and immunotherapeutics: current clinical developments. Mol. Ther. 2009;17:585-92.
21. M.L. Bagarazzi, J. Yan, M.P. Morrow, and et al. Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses Sci. Transl. Med. 4 2012 155ra38
22. C.L. Trimble, M.P. Morrow, K.A. Kraynyak, and et al. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial Lancet 2015
23. C.L. Trimble, S. Peng, F. Kos, and et al. A phase I trial of a human papillomavirus DNA vaccine for HPV16 + cervical intraepithelial neoplasia 2/3 Clin. Cancer Res. 15 2009 361 367
24. L. Maldonado, J.E. Teague, M.P. Morrow, and et al. Intramuscular therapeutic vaccination targeting HPV16 induces T cell responses that localize in mucosal lesions Sci. Transl. Med. 6 2014 221ra13
25. T.S. Kupper, and R.C. Fuhlbrigge Immune surveillance in the skin: mechanisms and clinical consequences Nat. Rev. Immunol. 4 2004 211 222
26. L.M. Ebert, P. Schaerli, and B. Moser Chemokine-mediated control of T cell traffic in lymphoid and peripheral tissues Mol. Immunol. 42 2005 799 809
27. P. Schaerli, L. Ebert, K. Willimann, and et al. A skin-selective homing mechanism for human immune surveillance T cells J. Exp. Med. 199 2004 1265 1275
28. R.A. Clark, B. Chong, N. Mirchandani, and et al. The vast majority of CLA + T cells are resident in normal skin J. Immunol. 176 2006 4431 4439
29. C.L. Trimble, S. Peng, C. Thoburn, F. Kos, and T.C. Wu Naturally occurring systemic immune responses to HPV antigens do not predict regression of CIN2/3 Cancer Immunol. Immunother. 59 2011 799 803
30. H. Wagner The immunobiology of the TLR9 subfamily Trends Immunol. 25 2004 381 386
31. Chuang CM, Monie A, Hung CF, Wu TC. Treatment with imiquimod enhances antitumor immunity induced by therapeutic HPV DNA vaccination. J. Biomed. Sci. 2010 Apr 28;17:32. doi: http://dx.doi.org/10.1186/1423-0127-17-32.
32. S. Daayana, E. Elkod, U. Winters, M. Pawlita, R. Roden, P.L. Stern, and H.C. Kitchener Phase II trial of imiquimod and HPV therapeutic vaccination in patients with vulva intraepithelial neoplasia Br. J. Cancer 102 2010 1129 1136