Table 3.
Selected early landmark therapeutic vaccine trials for HPV-mediated premalignancies and malignancies
| Antigen delivery system category, vaccine, and PMID identifier | Year | Journal | No. of citations* | Phase | N | Eligibility/enrolled | Adjuvant | Clinical and other notable outcomes |
|---|---|---|---|---|---|---|---|---|
| Small nucleic acids GX-188E ([DNA plasmid encoding HPV16 and 18 E6/E7 fusion protein] + FLT3L [Fms-like tyrosine kinase-3 ligand]) | ||||||||
| 25354725 [59] | 2014 | Nat Commun | 92 | I | 9 | CIN3 | IL-12# | 7/9 with complete lesion regression and viral clearance within 36 weeks of follow-up |
| Viral vector TA-HPV (tissue-antigen-HPV: recombinant vaccinia virus expressing HPV16/18 + E6/7 proteins) | ||||||||
| 8684105 [56•] | 1996 | Lancet | 111 | I/II | 8 | Invasive CC | - | 2/8 disease-free at 15 and 21 months, respectively |
| Bacterial vector ADXS11-001 (ADXS-HPV; axalimogene filolisbac [AXAL]; Lm-LLO-E7; live attenuated Listeria monocytogenes encoding HPV 16 E7 and tLLO) | ||||||||
| 19389451 [60] | 2009 | Vaccine | 145 | I | 15 | A/R CC | tLLO# | Flu-like syndrome in 100% patients, grade 3 AEs in 40% of patients; no grade 4/5 AEs; 1/15 with partial response |
| Peptides ISA101 (HPV16 E6/E7-SLPs [nine E6 SLPs, four E7 SLPs) | ||||||||
| 19890126 [58•] | 2009 | N Engl J Med | 406 | II | 22 | HPV16 + VIN3 | Montanide® ISA-51 | Objective clinical response in 79% of patients (n = 15/19) including complete response in 47% (n = 9/19) at 12 months |
| Protein(s) TA-CIN (tissue-antigen CIN; HPV16 L2/E6/E7 fusion protein) | ||||||||
| 20234368 [57] | 2010 | Br J Cancer | 98 | II | 19 | VIN2/3 | Imiquimod 5% cream | Complete regression of VIN in 58% (n = 11/19) patients at 20-weeks |
*Citation number per pubmed.gov, as of 09/4/2022