Table 2.
Clinical trials using DNA vaccines for cancer treatment.
| Phase | Type of Cancer |
Site of Administration and Delivery Method |
Description of Intervention and Key Results | Trial/ Status/ Reference |
|---|---|---|---|---|
| I | Stage III–IV or Recurrent Ovarian Cancer | Intradermal injection | Intervention: pUMVC3-hIGFBP-polyepitope DNA vaccine encoding Insulin-Like Growth Factor Binding Protein-2 (IGFBP-2) mixed with rhuGM-CSF monthly for three months. Key results: Stimulates the production of type 1 T lymphocytes without evidence of regulatory responses |
NCT01322802/ Completed/ [193] |
| II | Non-metastasic castration-sensitive prostate cancer (CSPC) | Intradermal injection | Intervention: pTVG-HP DNA vaccine encoding PAP with rhGM-CSF. Key results: No overall increase in 2-year metastasis-free survival (MFS). |
NCT01341652/ Completed/ [194] |
| II | Metastatic castration-resistant prostate cancer (CRPC) | Intradermal injection | Intervention: sipuleucel-T with or without pTVG-HP DNA vaccine encoding PAP Key results: The combination of sipuleucel-T with pTVG-HP can increase the diversity of the cellular and humoral immune response. |
NCT01706458/ Completed/ [195] |
| II | Metastasic CRPC | Intradermal injection | Intervention: pTVG-HP is a plasmid encoding PAP, with Pembrolizumab, a (PD-1)-blocking antibody No study results are available |
NCT04090528/ Recruiting/ [196] |
| I | Head and Neck Cancer | Intramuscular injection and electroporation | Intervention: pNGVL-4a-CRT/E7 (detox) DNA vaccine encoding calreticulin and HPV-16 E7 antigen with cyclophosphamide No study results are available |
NCT01493154/ Terminated/ [197] |
| I | Nine types of cancer | Intramuscular injection and electroporation | Intervention: INO-1400 or INO-1401 Plasmid encoding hTERT variants, with or with-out plasmid encoding IL-12 Key results: Survival of patients with pancreatic cancer, tolerance, enhanced CD8+ response |
NCT02960594/ Completed/ [164] |
| I | Prostate cancer | Intramuscular injection and electroporation | Intervention: INO-5150 encoding PSA and PSMA with and without INO-9012 encoding IL-12 Key results: Dampening percentage rise in PSA and increased PSA Doubling Time (PSADT) in patients. |
NCT02514213/ Completed/ [198] |
| IB | Breast Cancer | Injection and electroporation | Intervention: Mammaglobin-A DNA vaccine No study results are available |
NCT02204098/ Recruiting/ [199] |
| I, II | Cervical intraepithelilal neoplasia (CIN) 2/3 | Intramuscular injection | Intervention: VB10.16 vaccine (HPV-16 E7/E6 protein linked to human chemokine MIP-1α) Key results: Tolerance and promising immunogenicity results dependent on specific T lymphocytes |
NCT02529930/ Completed/ [200] |
| I, IIA | Cervical Cancer | Intramuscular injection and electroporation | Intervention: INO-3112 DNA vaccine (VGX-3100 encoding for modified HPV-16 and HPV-18, E6 and E7 antigens, and INO-9012 encoding IL-12) No study results are available |
NCT02172911/ Completed/ [201] |
| I, IIA | Head and Neck Cancer | Intramuscular injection and electroporation | Intervention: MEDI0457 (DNA immunotherapy targeting HPV16/18 E6/E7 with IL-12 encoding plasmids) in combination with Durvalumab for PD-1/PD-L1 blockade Key results: Durable antigen-specific peripheral and tumor immune responses. |
NCT03162224/ Completed/ [202] |
| II | CIN 3 | Intramuscular injection and electroporation | Intervention: GX-188E is a DNA vaccine encoding HPV-16 and HPV-18 E6/E7 fusion proteins Key results: Effective therapeutic vaccine with histopathologic regression and significantly higher fold changes in their IFNγ |
NCT02139267/ Completed/ [203] |
| II | Cervical cancer | Intramuscular injection and electroporation | Intervention: GX-188E DNA vaccine plus Pembrolizumab PD-1-blocking antibody Key results: This combination therapy showed preliminary antitumor activity |
NCT03444376/ Active, not recruiting/ [204] |
| II | Cervical Cancer | Intramuscular injection | Intervention: VB10.16 vaccine (HPV16 E7/E6 protein linked to human chemokine MIP-1α) in combination with Atezolizumab PD-L1-blocking antibody Key results: No study results are available |
NCT04405349/ Active, not recruiting/ [205] |
| II | Merkel Cell Carcinoma | Intratumural injection and electroporation | Intervention: DNA vaccine encoding IL-12 Key results: The vaccine is secure, and produces a systemic immune response, increased peripheral and intratumoral specific T cells |
NCT01440816/ Completed/ [190] |
| II | Melanoma | Intratumural injection and electroporation | Intervention: DNA vaccine encoding IL-12 Key results: Circulating PD-1+ CD4+ and CD8+ T cells declined with treatment; specific immune responses to gp100 were also detected and were correlated with an increase in CD8+, CD3+ T cells within the tumor. |
NCT01502293/ Completed/ [167] |