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Table 2 Ongoing therapeutic HPV vaccine clinical trials

From: Perspectives for therapeutic HPV vaccine development

Vaccine Antigen(s) Construct Organization Trial Design Estimated Date of Trial Completion Clinical Trials.gov Identifier
Persistent HPV Infection and Low-Grade Squamous Intraepithelial Lesion
 PDS0101 HPV-16 E6/E7 R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides HPV-16 E6 and E7 PDS Biotechnology Corp. Phase I in female patients with high risk HPV infection or CIN1 (18 estimated patients) Information not provided NCT02065973
 ProCervix HPV-16/18 E7 2 recombinant adenylate cyclase (CyaA) proteins: CyaA-HPV 16E7 & CyaA-HPV 18E7 Genticel Phase II in female patients with HPV16/18+ infection or ASCUS/LSIL (220 estimated patients) December 2016 NCT01957878
Cervical Intraepithelial Neoplasia (CIN)/High-Grade Squamous Intraepithelial Lesion
 GX-188E HPV-16/18 E6/E7 Plasmid encoding fusion protein of HPV 16/18 E6/E7 linked to Flt3L and tpa Genexine, Inc Phase II in HPV 16/18+ CIN2, CIN2/3, and CIN3 patients in Eastern Europe (120 estimated patients) December 2017 NCT02596243
Phase II in HPV 16/18+ CIN3 patients in South Korea (72 estimated patients) October 2016 NCT02139267
 pNGVL4a-CRT/E7(detox) HPV-16 E7 Plasmid encoding mutated form of HPV16-E7 linked to calreticulin Sidney Kimmel Comprehensive Cancer Center Phase I in patients with HPV16+ CIN2/3 (39 estimated patients) March 2017 NCT00988559
 pNGVL4a-sig/E7(detox)/HSP70 + TA-HPV HPV-16/18 E6/E7 Plasmid encoding mutated form of HPV16-E7 linked to sig and HSP70 and vaccinia virus with HPV16/18 E6/E7 Phase I in patients with HPV16+ CIN3 in combination with topical imiquimod (48 estimated patients) December 2016 NCT00788164
 TVGV-1 +
 GPI-0100
HPV-16 E7 Fusion protein of HPV-16 E7 and ER targeting sequence THEVAX Genetics Vaccine Co. Phase IIa in patients with HPV induced cervical HSIL (51 estimated patients) June 2017 NCT02576561
 Pepcan + Candin HPV-16 E6 HPV16 E6 peptides combined with Candida skin testing reagent candin. University of Arkansas Phase II in patients with cervical HSIL (125 estimated patients) August 2020 NCT02481414
Anal Intraepithelial Neoplasia (AIN)
 ISA101
 (SLP-HPV-01; HPV16-SLP)
HPV-16 E6/E7 Combination of nine HPV-16 E6 and four HPV-16 E7 synthetic peptides with incomplete Freund’s adjuvant ISA Pharmaceuticals Phase I/II in HIV+ male patients with HPV-16+ AIN2/3 (45 estimated patients) February 2018 NCT01923116
 ADXS11-001 (Lm-LLo-E7) HPV-16-E7 prfA-defective Listeria monocytogenes strain transformed with plasmid encoding HPV-16 E7 antigen fused to a fragment of nonhemolytic listeriolysin O (LLO) Advaxis, Inc. Phase II trial in patients with persistent, recurrent, loco-regional, or metastatic anal cancer or HPV+ squamous cell carcinoma of the rectum that are either treatment naïve in the metastatic setting or have progressed or become intolerant to platinum based therapy (55 estimated patients) March 2017 NCT02399813
HPV-Associated Incurable Solid Tumors
 ISA101
 (SLP-HPV-01; HPV16-SLP)
HPV-16 E6/E7 Combination of nine HPV-16 E6 and four HPV-16 E7 synthetic peptides with incomplete Freund’s adjuvant ISA Pharmaceuticals Phase II in patients with HPV-16+ Incurable solid tumors (oropharyngeal squamous cell carcinoma, cervical, vulvar, vaginal, anal, and penile cancer) as combination therapy with Nivolumab (28 estimated patients) December 2018 NCT02426892
 DPX-E7 HPV-16 E7 HPV16-E711-19 nanomer Dana-Farber Cancer Institute Phase Ib/II trial in HLA-A*02 positive patients with incurable HPV 16-related oropharyngeal, cervical and anal cancer (44 estimated patients) May 2023 NCT02865135
Head and Neck Cancer
 ADXS11-001 (Lm-LLo-E7) HPV-16-E7 prfA-defective Listeria monocytogenes strain transformed with plasmid encoding HPV-16 E7 antigen fused to a fragment of nonhemolytic listeriolysin O (LLO) Advaxis, Inc. Phase II in patients with HPV+ Oropharyngeal Squamous Cell Carcinoma before robot-assisted resection (30 estimated patients) March 2017 NCT02002182
Phase I/II in patients with locally advanced or metastatic cervical or HPV+ Head and nack cancer with or without MED14736 chemoblie (66 estimated patients) December 2019 NCT02291055
 INO-3112
 (VGX-3100 + INO-9012)
HPV-16/18 E6/E7 Mixture of three plasmids encoding optimized consensus of E6 and E7 antigen of HPV 16 and 18 and proprietary immune activator expressing IL-12 Inovio Pharmaceuticals Phase I/IIA in patients with HPV associated head and neck squamous cell carcinoma (25 estimated patients) December 2017 NCT02163057
Cervical Cancer
 ADXS11-001 (Lm-LLo-E7) HPV-16-E7 prfA-defective Listeria monocytogenes strain transformed with plasmid encoding HPV-16 E7 antigen fused to a fragment of nonhemolytic listeriolysin O (LLO) Advaxis, Inc. Phase II in patients with persistent or recurrent squamous or non-squamous cell carcinoma of the cervix (67 estimated patients) October 2018 NCT01266460
 INO-3112
 (VGX-3100 + INO-9012)
HPV-16/18 E6/E7 Mixture of three plasmids encoding optimized consensus of E6 and E7 antigen of HPV 16 and 18 and proprietary immune activator expressing IL-12 Inovio Pharmaceuticals Phase I/IIA in female patients with new, recurrent, or persistent cervical cancer (30 estimated patients) April 2019 NCT02172911
Phase II in patients with locally advanced cervical cancer as combination therapy with chemoradiation (126 estimated patients) May 2021 NCT02501278
 ISA101
 (SLP-HPV-01; HPV16-SLP)
HPV-16 E6/E7 Combination of nine HPV-16 E6 and four HPV-16 E7 synthetic peptides with incomplete Freund’s adjuvant ISA Pharmaceuticals Phase I/II in female patients with HPV-16+ advanced or recurrent cervical cancer (48 estimated patients) December 2016 NCT02128126
 TA-CIN +
 GPI-0100
HPV-16 E6/E7/L2 HPV16 E6E7L2 fusion protein + GPI-0100 adjuvant Sidney Kimmel Comprehensive Cancer Center Phase I in patients with HPV16 associated cervical cancer (30 estimated patients) May 2020 NCT02405221
  1. AGIN Ano Genital Intraepithelial Neoplasia, AIN Anal intraepithelial Neoplasia, ASCUC atypical squamous cells of undetermined significance, CIN Cervical intraepithelial neoplasia, ER Endoplasmic reticulum, HIV Human immunodeficiency virus, HPV Human papillomavirus, HSIL High-grade squamous intraepithelial lesion, LSIL Low-grade squamous intraepithelial lesion