Table 2.

Completed clinical trials that assessed the profile of DNA vaccines

Sr No	NCT	Study type and allocation	Title	Phase	Total no. of patients	Regimen	Outcome	Condition	Remarks	References
1	NCT00849121	Interventional, randomized	Two-Arm study of a DNA vaccine encoding prostatic acid phosphatase (PAP) in patients with non-metastatic castrate-resistant prostate cancer	I	17	pTVG-HP with rhGM-CSF Every 3 Months Post Week 12 pTVG-HP with rhGM-CSF Variable Dosing Post Week 12		Non-metastatic castrate-resistant prostate cancer	Excellent PAP-specific CTL response was observed. Also, the PSA doubling time did rise during the course of treatment. After receiving the therapy for year, 12/17 patients were free of metastasis	[18, 143]
2	NCT02172911	Interventional, non-randpmized	A study of INO-3112 DNA vaccine with electroporation in participants with cervical cancer	I/II	10	Curative therapy with INO-3112 Salvage therapy with INO-3112	Antibody responses against HPV oncoproteins were detected in up to 60% of patients	HPV-16 and/or 18-positive cervical carcinoma	TRAEs were all Grade 1, primarily injection site related. Adjuvant MEDI0457 (INO-3112) is feasible after chemoradiation for locally advanced and/or recurrent cervical cancer. More than half of the patients developed detectable immune responses to HPV antigens after treatment	[58, 144]
3	NCT01341652	Interventional, randomized	Phase II PAP plus GM-CSF Versus GM-CSF alone for non-metastatic prostate cancer	II	99	pTVG-HP vaccine with GM-CSF GM-CSF	Two-year MFS was not different between study arms (41.8% vaccine v 42.3%. PAP-specific T cells were detected in both cohorts, including multifunctional PAP-specific T-helper 1–biased T cells	Non-metastatic prostate cancer	Except for a subset with quickly progressing disease, pTVG-HP therapy did not show a general increase in 2-year MFS in patients with castration-sensitive prostate cancer	[139, 145]
4	NCT01440816	Interventional, non-randomized	IL-12 gene and in Vivo electroporation-mediated plasmid DNA vaccine therapy in patients with merkel cell cancer (MCC)	II	15	One cycle of tavo with dose of 0.5 mg/ml followed by electroporation and proceeded to definitive treatment Four cycles of tavo with dose of 0.5 mg/ml followed by electroporation, with 12 weeks between each cycle and continuing till 12 months	The ORR was 25% (3/12) in cohort B, with 2 patients experiencing durable clinical benefit (16 and 55 + months, respectively). Two cohort A patients were recurrence-free at 44 + and 75 + months, respectively	Merkel cell carcinoma	The therapy was safe and feasible and no toxicities were observed. Several individuals experienced systemic immune responses and clinically significant benefits as a result of the sustained local production of the IL12 protein and local inflammation	[146, 147]
5	NCT00199849	Interventional, non-randomized	NY-ESO-1 plasmid DNA (pPJV7611) cancer vaccine	I	18	4 µg administered as 4 × 1 µg PMEDs 8 µg administered as 8 × 1 µg PMEDs 8 µg as a cluster dosage of 4 doses (6 6 8 8) as 2 × 1 µg PMEDs per day		Prostate cancer Bladder cancer Non-small cell lung cancer Esophageal cancer Sarcoma	Most patients demonstrated an overall rise in antibody titer and NY-ESO-1-specific CD4 + and CD8 + T cells. Besides that, not all patients experienced a positive delayed-type hypersensitivity (DTH) reaction to the protein NY-ESO-1	[148, 149]
6	NCT00398073	Interventional, randomized	Vaccine therapy in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma	I	35	Insertion of mouse gp100 DNA through PMED Insertion of mouse gp100 DNA through intramuscular injection		Melanoma	The trial demonstrated that the evoked immune responses reduce tumor development and increase survival	[102, 150]