Table 4.

Completed clinical trials combining DNA Vaccines with other therapies

Sr. No	NCT no	Study type and allocation	Title	Phase	Total no. of patients	Regimen	Outcome	Condition	Remarks	References
DNA Vaccines in combination with chemotherapy/ICIs
1	NCT03532217	Interventional	Neoantigen DNA vaccine in combination with Nivolumab/Ipilimumab and PROSTVAC in metastatic hormone-sensitive prostate cancer	I	19	PROSTVAC/Ipilimumab/Nivolumab/Neoantigen DNA vaccine	Treatment was well-tolerated with only 2 (2.4%) grade 3 TRAEs of colitis, and no grade 4 + TRAEs	Metastatic hormone-sensitive prostate cancer	Increases in activation/co-stimulatory/co-inhibitory seen after treatment with Prostvac/ICB, suggest immune priming	[164, 165]
2	NCT01673217	Interventional	Decitabine, vaccine therapy, and pegylated liposomal doxorubicin hydrochloride in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer	I	18	Decitabine intravenously (IV) over 3 h on day 1, pegylated liposomal doxorubicin hydrochloride IV on day 8, and NY-ESO-1 peptide vaccine emulsified in incomplete Freund's adjuvant and sargramostim subcutaneously on day 15	–	Recurrent fallopian tube cancer, Recurrent ovarian epithelial cancer, Recurrent primary peritoneal cavity cancer	–	[166]
3	NCT00113984	Interventional	Vaccine and antibody treatment of prostate cancer	I	30	Biological: PROSTVAC-V/TRICOM Biological: PROSTVAC-F/TRICOM Drug: MDX-010 Drug: Sargramostim	3 of 30 patients had grade 1 reactions and 26 had grade 2 reactions. 21 patients had grade 2 or greater immune-related adverse events	Prostatic neoplasm	The use of a vaccine targeting PSA that also enhances co-stimulation of the immune system did not seem to exacerbate the immune-related adverse events associated with ipilimumab	[167, 168]
DNA vaccines in combination with targeted therapy
4	NCT02529930	Interventional, non-randomized	An exploratory safety and immunogenicity study of HPV16 + immunotherapy VB10.16 in Women With HSIL; CIN 2/3)	I/II	34	VB10.16 Immunotherapy (DNA vaccine)	AEs were mainly mild to moderate and related to the injection site. No SAEs or DLTs were reported	High Grade Cervical Intraepithelial Neoplasia	Strongly encouraging phase 1/2a safety, tolerability, and immunogenicity results for a therapeutic HPV16 DNA plasmid vaccine VB10 was reported	[169, 170]
5	NCT00179309	Interventional, randomized	Docetaxel alone or in combination with vaccine to treat breast cancer	II	48	Arm 1: PANVAC + docetaxel Arm 2: docetaxel alone	PFS is 6.6 vs. 3.8 months in A vs. B. toxicity levels were same in both the arms	Breast cancer	This study demonstrated that the combination of PANVAC with DOC in metastatic breast cancer may provide a clinical benefit compared to DOC alone	[171, 172]