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. 2012 Nov 2;5:315–328. doi: 10.2147/OTT.S25123

Table 2.

Gene therapy clinical trials worldwide on cervical cancer from 1989 to 2012

ID trial Title/Country Indication/clinical phase Status/year approved-initiated Gene(s) transferred Vector used/administration route Gene delivery
BE-0024 A randomized, double-blind, placebo-controlled, parallel group, multi-center study of the safety and response rate of 3 subcutaneously administered doses of 5 × 107 pfu RO5217790 in patients with high-grade cervical intraepithelial neoplasia grade 2 or 3 associated with high-risk HPV infection. Belgium Cervical intraepithelial neoplasia.
Phase I		 Open
2009–ND

  • delE6

  • delE7

  • IL-2

 Vaccinia virus/ND ND
CH-0035 Immunotherapy for stage I cervical carcinoma. Switzerland Stage I cervical carcinoma.
Phase I		 Closed
1999–2002

  • IL-2

 Vaccinia virus/intramuscular ND
CH-0036 Immunotherapy for advanced cervical carcinoma. Switzerland Advanced cervical carcinoma.
Phase I		 Closed
1999–2002

  • IL-2

 Vaccinia virus/intramuscular ND
CN-0010 Gendicine intratumoral injection combined with radiotherapy for advanced cervical carcinoma. China Cervical carcinoma.
Phase III		 Open
2008–ND

  • p53

 Adenovirus/intramuscular ND
ES-0010 A randomized, double-blind, placebo-controlled, parallel group, multi-center study on the safety and response rate of 3 subcutaneously administered doses of 5 × 107 pfu RO5217790 in patients with high-grade cervical intraepithelial neoplasia grade 2 or 3 associated with high-risk HPV infection. Spain Cervical intraepithelial neoplasia.
Phase I		 Open
2009–ND

  • delE6

  • delE7

  • IL-2

 Vaccinia virus/ND ND
FR-0032 Phase II trial to assess efficacy of TG4001 (MVA-HPV-IL2) in patients with grade 2/3 cervical intra-epithelial neoplasia (CIN 2/3) linked to HPV16 infection (protocol TH4001.07). France CIN 2 and 3.
Phase II		 Open
2004–ND

  • IL-2

  • HPV16

 Vaccinia virus/ND ND
MX-0001 Clinical protocol. 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. Mexico Cervical cancer.
Phase II		 Open
ND–ND

  • ND

 Adenovirus/ND ND
UK-0041 Use of a recombinant Vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UK Cervical intraepithelial neoplasia III.
Phase I		 Open
1996–ND

  • HPV E6 and E7 oncogenes

 Poxvirus/ND ND
UK-0042 Use of a recombinant Vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UK Cervical intraepithelial neoplasia III.
Phase I		 Open
1997–ND

  • HPV E6 and E7 oncogenes

 Poxvirus/ND ND
UK-0046 Use of a recombinant Vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UK Cervical intraeptihelial carcinoma III.
Phase I		 Closed
1996–ND

  • HPV E6 and E7 oncogenes

 Vaccinia virus/ND In vivo
UK-0047 Use of a recombinant Vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UK Cervical intraeptihelial carcinoma III.
Phase I		 Closed
1998–ND

  • HPV E6 and E7 oncogenes

 Vaccinia virus/ND In vivo
UK-0071 A Phase II, multi-center, double- blind, placebo-controlled, dose finding study of ZYC101a in the treatment of high-grade squamous intra-epithelial lesions of the uterine cervix. UK Ano-genital neoplasia III.
Phase II		 Open
2001-ND

  • HPV E6 and E7 oncogenes

 Naked plasmid DNA/ND ND
UK-0074 TA-HPV recombinant vaccinia virus expressing the human papillomavirus 16 and 18 E6 and E7 proteins: application to amend currently approved protocol to add a clinical trial involving prime-boost strategy of TA-CIN administered in association with TA-HPV in high-grade ano-genital intraepithelial neoplasia (AGIN) patients (PB-HPV/01). UK Cervical cancer.
Phase I		 Open
2001–ND

  • HPV E6 and E7 oncogenes

 Vaccinia virus/ND ND
US-0307 Phase I trial of immunotherapy with MVA-HPV-IL2 (TG4001) in women with cervical intraepithelial neoplasia (CIN) Grade 3. USA Cervical cancer.
Phase I		 Closed
1999–ND

  • HPV E6 and E7 oncogenes

  • IL-2

 Poxvirus/intramuscular In vivo
US-0309 Phase I trial of immunotherapy with MVA-HPV-IL2 (TG4001) in women with advanced cervical carcinoma. USA Cervical cancer.
Phase I		 Closed
1999–ND

  • HPV E6 and E7 oncogenes

  • IL-2

 Poxvirus/intramuscular In vivo
US-0592 A phase I study to determine the safety and immunogenicity of vaccination with Listeria monocytogenes expressing HPV type 16 E7 for the treatment of progressive, recurrent, and advanced squamous cell cancer of the cervix. USA Cervical cancer.
Phase I		 Open
2003–ND

  • HPV E7 oncogene

 Listeria monocytogenes/intravenous In vivo
US-0595 A Phase I/II clinical trial of pNGVL4a-Sig/E7 (detox)/HSP70 for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3). USA Cervical cancer.
Phase I and II		 Open
2003–ND

  • HPV16 E7 oncogene

 Naked plasmid DNA/intramuscular In vivo
US-0916 Phase I, open-label, dose escalation study to evaluate the safety, tolerability, and immunogenicity of HPV DNA plasmid (VGX-3100) + electroporation (EP) in adult females with histological diagnosis of grade 2 or 3 cervical intraepithelial neoplasia (CIN). USA Cervical cancer.
Phase I		 Open
2008–ND

  • HPV16 E6 and E7 oncogenes

  • HPV18 E6 and E7 oncogenes

 Naked plasmid DNA/intramuscular In vivo
US-0928 A Phase I efficacy and safety study of HPV16-specific therapeutic DNA-rVaccinia vaccination in combination with topical imiquimod in patients with HPV16+ high-grade cervical dysplasia (CIN3). USA HPV16+ high grade cervical dysplasia.
Phase I		 Open
2008–ND

  • HPV16 + HPV18

  • E6 + E7 oncogenes

 Naked plasmid DNA + vaccinia virus/intramuscular In vivo
US-0958 A randomized, double-blind, placebo-controlled, parallel group, multi-center study of the safety and response rate of 3 subcutaneously administered doses of 5 × 107 pfu R05217790 in patients with high-grade cervical intraepithelial neoplasia grade 2 or 3 associated with high-risk HPV infection. USA Cervical intraepithelial neoplasia (CIN).
Phase II		 Open
2008–ND

  • HPV E6 and E7 oncogenes

  • IL-2

 Vaccinia virus/intramuscular In vivo
US-0984 A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3). USA Cervical cancer.
Phase I/II		 Open
2009–ND

  • HPV16 E7 oncogene

 Naked plasmid DNA/intramuscular In vivo
US-1040 Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of a 4th dose of HPV DNA plasmid (VGX-3100) + electroporation (EP) in adult females previously immunized with VGX-3100. USA Cervical cancer.
Phase I		 Open
2010–ND

  • HPV16 E6 and E7 oncogenes

  • HPV18 E6 and E7 oncogenes

 Naked plasmid DNA/intramuscular In vivo
US-1082 A Phase II evaluation of ADXS11-001 (NSC #752718, IND # 13,712) in the treatment of persistent or recurrent squamous or on-squamous cell carcinoma of the cervix. USA Cervical cancer.
Phase II		 Open
2010–ND

  • HPV E7 oncogene

 Listeria monocytogenes/intravenous In vivo
US-1093 Phase II placebo-controlled study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA vaccine) delivered IM followed by electroporation (Ep) with cellectra-5p for the treatment of biopsy-proven CIN 2/3 or CIN 3 with documented HPV 16 or 18. USA Cervical cancer.
Phase II		 Open
2011–ND

  • HPV16 E6-E7 fusion protein

  • HPV18 E6-E7 fusion protein

 Naked plasmid DNA/intramuscular In vivo
XX-0006 Gene therapy in patients with stage I cervical carcinoma. Multi-country Stage I cervical carcinoma.
Phase I		 Closed
1999–2002

  • HPV

  • IL-2

 Vaccinia virus/intramuscular ND
XX-0007 Gene therapy in patients with advanced cervical carcinoma. Multi-country Advanced cervical carcinoma.
Phase I		 Closed
1999–2002

  • HPV

  • IL-2

 Vaccinia virus/intramuscular ND

Note: Copyright © 2012, John Wiley and Sons. Adapted with permission from ABEDIA [webpage on the Internet]. Database of clinical trials [updated Jun 2012]. Available from: http://www.abedia.com/wiley/index.html. Accessed August 1, 2012.67

Abbreviations: HPV, human papillovirus; ND, no data provided.