Table 2.
Clinical trials for HPV-associated pre-neoplastic lesions
| Vaccine | Antigen(s) | Phase | Lesions |
|---|---|---|---|
| ADXS11-001: |
HPV-16 E7 |
II |
CIN 2/3, VIN 3, VAIN 2 |
| Lm secreting fusion/LLO-HPV-16 E7 protein (Lm-LLO-E7) |
|
|
|
| Procervix: adenylate cyclase protein vector delivering HPV16 and HPV18 E7 antigens |
HPV-16 and HPV-18 E7 |
I/II |
High-risk HPV infections before CIN appearance |
| MVA E2: Recombinant Modified Vaccinia Ankara (MVA) encoding E2 from BPV |
Bovine Papillomavirus E2 |
I/II |
CIN1-3 |
| |
I/II |
Male flat condyloma |
|
| |
II |
High-grade CIN |
|
| TG4001/R3484: |
HPV-16 E6/E7 |
IIa |
CIN2/3 |
| Recombinant MVA expressing E6-E7of HPV-16, and IL-2 |
|
IIb |
|
| Peptides: HPV E7 (aa 12–20) plus E7 lipopetide (PADRE helper peptide, linker peptide, and E7 peptide: aa 86–93) & Montanide ISA-51 adjuvant |
HPV-16 E7 |
I |
High-grade CIN and |
| |
II |
VIN |
|
| |
II |
VIN 3 |
|
| |
|
HSIL |
|
| HPV-16 E6/ E7 fusion protein plus ISCOMATRIX adjuvant |
HPV-16 E6 and E7 |
I |
CIN 1–3, HPV-associated AIN in HIV-positive male |
| PD-E7: Modified HPV-16 E7/Hib protein D fusion protein & AS02B adjuvant |
HPV-16 E7 |
I/II |
CIN 1, CIN 3 |
| SGN-00101: HPV-16 E7/M. bovis, Hsp65 fusion protein |
HPV-16 E7 |
I/II |
Anal HSIL |
| |
I/II |
High-grade AIN |
|
| |
II |
ASCUS and LSIL, recurrent respiratory papillomatosis, high-grade CIN |
|
| SGN-00101 in poly ICLC adjuvant |
HPV-16 E7 |
I |
CIN 1-3 |
| ZYC101: Recombinant HPV-16 E7 DNA Plasmid encapsulated in poly microparticles |
HPV-16 E7 |
I |
High-grade AIN in males, CIN 2/3 |
| ZYC101a: Recombinant HPV-16 and HPV 18 E6-E7 DNA Plasmid encapsulated in poly microparticles |
HPV-16 and HPV-18 E6 and E7 |
II/III |
High grade CIN |
| pNGVL4a-Sig/E7/Hsp70: DNA plasmid expressing mutated HPV-16 E7 fused to Sig and Hsp70 |
HPV-16 E7 |
I |
CIN 2/3 |
| pNGVL4a-CRT/E7: DNA plasmid expressing mutated HPV-16 E7 fused to calreticulin |
HPV-16 E7 |
I |
CIN 2/3 |
| VGX-3100: DNA plasmid expressing HPV-16 and HPV-18 E6 and E7 proteins |
HPV-16 and HPV-18 E6 and E7 |
I |
CIN 2/3 (after surgery or fourth dose) |
| |
II |
CIN 2/3 |
|
| TA-CIN/TA-HPV prime/boost |
HPV-16 and HPV-18 E6 and E7 and HPV-16 L2 |
II |
CIN 2/3 |
| TA-HPV/TA-CIN prime/boost |
HPV-16 and HPV-18 E6 and E7 and HPV-16 L2 |
II |
CIN 2/3 |
| pNGVL4a-Sig/E7 /Hsp70 and TA-HPV prime/boost plus TLR agonist imiquimod | HPV-16 and HPV-18 E6 and E7 | II | CIN 2/3 |
Note: Abbreviations are as in the text.