Table 3.
Currently Ongoing Therapeutic HPV Vaccine Clinical Trials for Different HPV-Associated Diseases
| 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) | June 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) | December 2015 | 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) | July 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 |
| 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 |
| 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 |
| 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 |
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