Table 2.

Major clinical trials of biological vector-based cancer vaccines.

	Interventions	Carrier/source	Stage	Design and arms	Primary objective	Results	Phases	NCT Number
Viral vector-based vaccine	Ad5 [E1-, E2b-]- CEA(6D)	ADV	advanced CRC	Single arm: Ad5 [E1-, E2b-]-CEA(6D) (N=32)	Safety, immune response	There was minimal toxicity, OS at 12 months is 48%.	I/II	NCT01147965 (55)
	Ad5-hGCC-PADRE vaccine	ADV	stage I/II	Single arm: Ad5-hGCC-PADRE vaccine (N=10)	Safety, immune response	GUCY2C-specific T-cell responses were detected in 40% of patients. Adverse events were minimal.	I	NCT01972737 (56)
	PANVAC	poxvirus	mCRC	Arm 1: PANVAC + GM-CSF Arm 2: PANVAC + DCs	OS, RFS	2-year RFS (55% vs. 47%, p=0.22)	II	(57)
	Therapeutic autologous dendritic cells	PANVAX (viral vector)	mCRC	Vaccine arm: DC+PANVAC (N=39) Control arm: DC+GM-CSF(N=37)	RFS, immune response	RFS at 2 years was similar (47% and 55% for DC/PANVAX and PANVAX/GM-CSF, respectively). Specific T-cell responses against CEA was statistically similarly.	II	NCT00103142
	TroVax	MVA	mCRC	Single arm:TroVax (N=22)	Safety, immune response	Toxicity was minimal. Antigen-specific responses were observed.	I/II	(58)
	AVX701 (VRP-CEA(6D))	alphavirus	Stage III-IV	Arm 1: AVX701 (Stage IV, N=28) Arm 2: AVX701 (Stage III, N=12)	OS, RFS, immune response	Stage IV group: 5-year OS 17% (95% CI 6% to 33%) Stage III group: 5-year RFS 75% (95% CI 40% to 91%). An increase in CD8+TEM and a decrease in FOXP3+Trges were observed in 10/12.	I	(59)
Live-attenuated bacteria and yeast vaccines	GI-6207 (Yeast-CEA)	heat-killed yeast (Saccharomyces cerevisiae)	mCRC	Single arm: GI-6207 (N=22)	Safety, immune response	GI-6207 vaccination had minimal toxicity and induced certain antigen-specific T cell responses and CEA stabilization in patient population.	I	NCT00924092 (60)
	GI-6301 (Yeast Brachyury Vaccine)	yeast	advanced CRC	Single arm: GI-6301 at different dose levels (N=11)	Immune response, safety	Brachyury-specific T-cell responses was seen in the majority of patients. No evidence of autoimmunity or serious adverse events was observed.	I	NCT01519817 (61)
	GI-4000 ( whole, heat-killed, recombinant Saccharomyces cerevisiae yeast, engineered to encode ras oncogene)	yeast	advanced CRC (with specific ras mutation)	Single arm: GI-4000 (N=19)	Safety, immune response	GI-4000 demonstrated a favorable safety profile and immunogenicity in the majority of subjects.	I	(62)

ADV, adenovirus; MVA, modified vaccinia Ankara; OS, overall survival; RFS, recurrence-free survival; mCRC, metastatic colorectal cancer.