Table 1.

Ongoing clinical trials focusing on the development of the DNA vaccines against cancer

Sr No	NCT	Study type and allocation	Title	Status	Phase	Total no. of patients	Regimen	Condition	Outcomes	References
1	NCT05455658	Interventional	STEMVAC in patients with early stage triple negative breast cancer	Recruiting	II	33	STEMVAC in combination with sargramostim	Triple negative breast cancer	1 Outcome: cellular immune response 2 Outcome: incidence of AEs, RFS	[105, 106]
2	NCT02157051	Interventional, non-randomizsed	Vaccine therapy in treating patients with HER2-negative stage III-IV breast cancer	Active, not recruiting	I	42	STEMVAC in combination with sargramostim	Triple negative breast cancer	1 Outcome: incidence of toxicity, immunologic efficacy 2 Outcome: Memory Th1 dominant immune response, modulation of Tregs, Modulation of MDSC, STEMVAC specific Type 1 immune response	[107, 108]
3	NCT02780401	Interventional	Vaccine therapy in preventing cancer recurrence in patients with non-metastatic, node positive, HER2 negative breast cancer that is in remission (WOKVAC)	Active, not recruiting	I	24	WOKVAC in combination with Sargramostim	Non-metastatic, node positive, HER2-negative breast cancer	1 Outcome: incidence of toxicity 2 Outcome: Assessment of IgG antibodies and T-helper Th1:Th2 ratio, modulation of Tregs, Modulation of MDSC, Assessment of the immunogenicity of WOKVAC	[105, 109, 110]
4	NCT05242965	Interventional, randomized	A Multiple antigen vaccine (STEMVAC) for the treatment of patients With stage IV non-squamous non-small cell lung cancer	Recruiting	II	40	STEMVAC combined with sargramostim	Non-small cell lung cancer	1 Outcome: Change from baseline percentage of CD8 + TIL in patients, incidence of AEs 2 Outcome; ORR, OS, PFS, Magnitude of the immune response, Vaccine induced T-cells traffic to tumor	[16, 111]
5	NCT03988283	Interventional	Neoepitope-based personalized DNA vaccine approach in pediatric patients with recurrent brain tumors	Not yet recruiting	I	10	Personalized neoantigen DNA vaccine	Recurrent brain tumors	1 Outcome: safety and tolerability 2 Outcome: median PFS and median OS	[112, 113]
6	NCT04015700	Interventional	Neoantigen-based personalized DNA vaccine in patients with newly diagnosed, unmethylated glioblastoma	Active, not recruiting	I	9	Personalized neoantigen DNA vaccine Plasmid encoded IL-12	Unmethylated glioblastoma	1 Outcome: safety and tolerability 2 Outcome: immunogenicity, PFS, OS	[114, 115]
7	NCT03600350	Interventional	pTVG-HP and Nivolumab in patients with non-metastatic PSA-recurrent prostate cancer	Active, not recruiting	II	19	DNA vaccine encoding prostatic acid phosphatase when combined with  Nivolumab Sargramostim	Non-metastatic, PSA-recurrent prostate cancer	1 Outcome: patients with acceptable toxicities boundaries, PSA-CR rate 2 Outcome: PSA doubling time, PSA response rate, median radiographic PFS, metastasis free-survival rate	[116, 117]
8	NCT04090528	Interventional, randomized	pTVG-HP DNA vaccine with or without pTVG-AR DNA vaccine and pembrolizumab in patients with castration-resistant, metastatic prostate cancer	Recruiting	II	60	pTVG-HP combined with  pTVG-AR Pembrolizumab	Castration-resistant, metastatic prostate cancer	1 Outcome: PFS 2 Outcome: ORR, OS, safety and tolerability, median radiographic PFS	[105, 118]
9	NCT03199040	Interventional, randomized	Neoantigen DNA vaccine alone vs. neoantigen DNA vaccine plus Durvalumab in triple negative breast cancer patients following standard of care therapy	Active, not recruiting	I	18	Neoantigen DNA vaccine in combination Durvalumab	Triple negative breast cancer	1 Outcome: safety 2 Outcome: immune response	[50, 119]
10	NCT04131413	Interventional, non-randomized	HPV DNA vaccine via electroporation for HPV16 positive cervical neoplasia	Recruiting	I	48	pNGVL4aCRTE6E7L2	HPV16 positive cervical neoplasia	1 Outcome: no. of patients experiencing DLTs	[120, 121]
11	NCT04989946	Interventional, randomized	Androgen deprivation, with or without pTVG-AR, and with or without nivolumab, in patients with newly diagnosed, high-risk prostate cancer	Recruiting	I/II	39	pTVG-AR combined with Degarelix, Nivolumab	Prostate cancer	1 Outcome: pCR, MRD, incidence of AEs, toxicity rates 2 Outcome: PFS at 1 year, RCB	[122, 123]
12	NCT04329065	Interventional	Concurrent WOKVAC vaccination, chemotherapy, and HER2-targeted monoclonal antibody therapy before surgery for the treatment of patients with breast cancer	Recruiting	II	16	WOKVAC and Paclitaxel and Trastuzumab Pertuzumab	Breast cancer	1 Outcome: Enumeration of the number of T-bet + , CD4 + , and CD8 + T-cells in TIL 2 Outcome: incidence of AEs, Induction of type 1 helper cell (Th1) immunity against HER2, IGF-1R, and IGFBP2	[124, 125]
13	NCT03439085	Interventional	DNA Plasmid-encoding Interleukin-12/HPV DNA plasmids therapeutic vaccine INO-3112 and Durvalumab in treating patients with recurrent or metastatic human papillomavirus associated cancers	Active, not recruiting	II	77	MEDI0457 with Durvalumab	Recurrent/metastatic human papilloma virus associated cancers	1 Outcome: ORR 2 Outcome: ORR, PFS, OS, DCR	[126, 127]
14	NCT03603808	Interventional	VGX-3100 and electroporation in treating patients with hiv-positive high-grade anal lesions	Recruiting	II	80	VGX-3100	HIV-associated anal neoplasia	1 Outcome: ORR 2 Outcome: safety and tolerability, ORR, CRR, viral clearance anal swab	[128, 129]
15	NCT04251117	Interventional	GNOS-PV02 personalized neoantigen vaccine, INO-9012 and pembrolizumab in subjects with advanced HCC	Recruiting	I/II	36	Personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) with Pembrolizumab (MK-3475)	Advanced hepatocellular carcinoma	1 Outcome; AEs, immunogenicity 2 Outcome: ORR, DCR, DOR, PFS, OS	[130, 131]