Table 5.
Other selected therapeutic vaccines for HPV-mediated premalignancies and malignancies under active or completed trial-based investigation, without published results
| Antigen delivery system category and vaccine | Clinicaltrials.gov identifier |
|---|---|
| Small nucleic acids | |
| ISA201 (two HPV16 E6 SLPs) + (Amplivant® [TLR2-L]) | NCT02821494 |
| HARE-40 (HPV anti-CD40 RNA vaccine) | NCT03418480 |
| Viral vector | |
| PRGN-2009 (gorilla adenovirus encoding HPV16/18 E6/E7 proteins) ± M7824 | NCT04432597 |
| Vvax001 (attenuated Semliki Forest Virus [SFV] encoding E6/E7 proteins) | NCT03141463 |
| Peptides | |
| P16-37–63 (p16INK4a 27-amino acid peptide fragment) + Montanide® ISA-51 VG | NCT02526316 |
| DPX-E7 (synthetic HPV16 E7 peptide consisting of amino acids 11–19) | NCT02865135 |
| Protein | |
| TA-CIN (tissue-antigen CIN; HPV16 L2/E6/E7 fusion protein) | NCT02405221 |
| TVGV-1 (HPV16 E7 bacterial exotoxin fusion protein) + GPI-0100 | NCT02576561 |
| ProCervix (two recombinant adenylate cyclase proteins, CyaA-HPV 16E7 and CyaA-HPV 18E7) + Aldara (5% imiquimod) | NCT01957878 |
| Autologous cell-based | |
| DCs loaded with HPV16/18 E6/E7, injected into adjacent lymph node × 6 | NCT03870113 |
| Peripheral blood mononuclear cells (PBMC) (antigen-presenting cells) treated in vitro with sargramostim (GM-CSF) pulsed with HPV16 E6 or E7, administered IV | NCT00019110 |
| Heterologous prime-boost | |
|
Ad-E6E7 (prime, viral vector vaccine: recombinant adenovirus encoding mutant, inactive HPV E6/E7 proteins) + MG1-E6E7 (boost, viral vector vaccine: recombinant, attenuated oncolytic rhabdovirus Maraba encoding HPV E6/E7 proteins; virus preferentially invades tumor cells, induces E6/E7 expression, lyses tumor cells, and invades adjacent tumor cells) |
NCT03618953 |
|
VTP-200 ChAdOx1-HPV recombinant, attenuated, chimpanzee adenovirus encoding conserved elements of HPV16/18/31/52/58 E1/E2/E4/E6/E7 proteins + MVA-HPV (boost) modified, attenuated vaccinia virus Ankara strain (MVA) encoding conserved elements of HPV16/18/31/52/58 E1/E2/E4/E6/E7 |
NCT04607850 |
Normal font: Trial in patients with HPV-mediated malignancies. Italicized font: Trial in patients with HPV-mediated premalignancies. CRT human calreticulin, a heat shock protein, LCMV lymphocytic choriomeningitis virus, M7824 (bintrafusp alfa) bifunctional fusion protein anti-PD-L1 human monoclonal antibody bound to extracellular domain of human TGF-β-receptor II, LLR2-L toll-like receptor 2 ligand