Table 2: Active gene therapy clinical trials for cervical cancer worldwide from 1989 to 2012.

ID trialTrial title/countryIndication/clinical phaseStatus/year approved-initiatedGene(s) transferred Vector used/administration routeGene delivery

BE-0024A randomized, double blind, placebo-controlled, parallel group, multicenter 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. BelgiumCervical intraepithelial neoplasia.
Phase I
Open
2009-ND
(i) delE6
(ii) delE7
(iii) IL-2
Vaccinia virus/NDND
CN-0010Gendicine intratumoral injection combined with radiotherapy for advanced cervical carcinoma. ChinaCervical carcinoma.
Phase III
Open
2008-ND
p53Adenovirus/intramuscularND
ES-0010A randomized, double blind, placebo-controlled, parallel group, multicenter 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. SpainCervical intraepithelial neoplasia.
Phase I
Open
2009-ND
(i) delE6
(ii) delE7
(iii) IL-2
Vaccinia virus/NDND
FR-0032Phase 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). FranceCIN 2 and 3.
Phase II
Open
2004-ND
(i) IL-2
(ii) HPV16
Vaccinia virus/NDND
MX-0001Clinical 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. MexicoCervical cancer.
Phase II
Open
ND-ND
NDAdenovirus/NDND
UK-0041Use of a recombinant vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UKCervical intraepithelial neoplasia III.
Phase I
Open
1996-ND
HPV E6 and E7 oncogenesPoxvirus/NDND
UK-0042Use of a recombinant vaccinia vaccine (TA-HPV) to treat cervical intraepithelial neoplasia III. UKCervical intraepithelial neoplasia III.
Phase I
Open
1997-ND
HPV E6 and E7 oncogenesPoxvirus/NDND
UK-0071A phase II, multicenter, double-blind, placebo-controlled, dose finding study of ZYC101a in the treatment of high-grade squamous intraepithelial lesions of the uterine cervix. UKAnogenital neoplasia III.
Phase II
Open
2001-ND
HPV E6 and E7 oncogenesNaked plasmid DNA/NDND
UK-0074TA-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 anogenital intraepithelial neoplasia (AGIN) patients (PB-HPV/01). UKCervical cancer.
Phase I
Open
2001-ND
HPV E6 and E7 oncogenesVaccinia virus/NDND
US-0592A phase 1 study to determine the safety and immunogenicity of vaccination with Listeria monocytogenes expressing human papilloma virus type 16 E7 for the treatment of progressive, recurrent, and advanced squamous cell cancer of the cervix. USACervical cancer.
Phase I
Open
2003-ND
HPV E7 oncogeneListeria monocytogenes/intravenousIn vivo
US-0595A 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). USACervical cancer.
Phases I and II
Open
2003-ND
HPV16 E7 oncogeneNaked plasmid DNA/intramuscularIn vivo
US-0916Phase I, open-label, dose escalation study to evaluate the safety, tolerability, and immunogenicity of human papillomavirus (HPV) DNA plasmid (VGX-3100) + electroporation (EP) in adult females with histological diagnosis of grade 2 or 3 cervical intraepithelial neoplasia (CIN). USACervical cancer.
Phase I
Open
2008-ND
(i) HPV16 E6 and E7 oncogenes
(ii) HPV18 E6 and E7 oncogenes
Naked plasmid DNA/intramuscularIn vivo
US-0928A phase I efficacy and safety study of HPV16-specific therapeutic DNA-r vaccinia vaccination in combination with topical imiquimod in patients with HPV16+ high grade cervical dysplasia (CIN3). USAHPV16+ high-grade cervical dysplasia.
Phase I
Open
2008-ND
(i) HPV16 + HPV18
(ii) E6 + E7 oncogenes
Naked plasmid DNA + Vaccinia virus/intramuscularIn vivo
US-0958A randomized, double blind, placebo-controlled, parallel group, multicenter 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. USACervical intraepithelial neoplasia (CIN).
Phase II
Open
2008-ND
(i) HPV E6 and E7 oncogenes
(ii) IL-2
Vaccinia virus/intramuscularIn vivo
US-0984A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3). USACervical cancer.
Phase I/II
Open
2009-ND
HPV16 E7 oncogeneNaked plasmid DNA/intramuscularIn vivo
US-1040Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of a fourth dose of human papillomavirus (HPV) DNA plasmid (VGX-3100) + electroporation (EP) in adult females previously immunized with VGX-3100. USACervical cancer.
Phase I
Open
2010-ND
(i) HPV16 E6 and E7 oncogenes
(ii) HPV18 E6 and E7 oncogenes
Naked plasmid DNA/intramuscularIn vivo
US-1082A 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. USACervical cancer.
Phase II
Open
2010-ND
HPV E7 oncogeneListeria monocytogenes/intravenousIn vivo
US-1093Phase 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. USACervical cancer.
Phase II
Open
2011-ND
(i) HPV16 E6-E7 fusion protein
(ii) HPV18 E6-E7 fusion protein
Naked plasmid DNA/intramuscularIn vivo

Clinical trial information obtained from http://www.abedia.com/wiley/index.html.
ND: no data provided.
Note. The table was created by the authors of this paper with the information obtained from http://www.abedia.com/wiley/index.html.