Trial Watch

Figures & data

Table 1. Recent clinical trials testing the therapeutic profile of DNA-based vaccines in cancer patients*

Indication(s)	Phase	Status	TAA(s)	Co-encoded molecule(s)	Co-therapy	Vector	Delivery	Ref.
Bladder carcinoma	II	Recruiting	CEA MUC1	CD80, CD57, ICAM1	BCG	Vaccinia virus (prime) Fowlpox virus (boost)	s.c.	NCT02015104
Breast carcinoma	I	Recruiting	MAMA	-	-	n.a.	i.m.	95
Colorectal carcinoma	I	Recruiting	CEA	-	-	Alphavirus-derived VRP	i.m.	NCT01890213
			GUCY2C	PADRE	-	Adenovirus serotype 5	i.m.	NCT01972737
Medullary thyroid cancer	II	Recruiting	CEA	-	-	Saccharomyces cerevisiae	s.c.	NCT01856920
Nasopharyngeal cancer	I	Recruiting	EBNA1 LMP2	-	-	MVA	i.d.	NCT01800071
	Ib	Recruiting	EBNA1 LMP2	-	-	MVA	i.d.	97
Oropharyngeal cancer	I	Recruiting	HPV-16 E7	-	-	Listeria monocytogenes	i.v.	NCT02002182
Prostate cancer	I	Completed	PSA	-	-	pVAX-based plasmid	i.d. + EP	94
			PSMA	-	-	Alphavirus-derived VRP	s.c.	98
	II	Recruiting	PSA	CD80, CD57, ICAM1	Enzalutamide	Vaccinia virus (prime) Fowlpox virus (boost)	s.c.	NCT01867333
								NCT01875250
Solid tumors	I	Completed	CEA HER2	LTB	-	pV1J-based plasmids	i.m. + EP	93
						pV1J-based plasmids (prime) Adenovirus serotype 6 (boost)	i.m. + EP	93
	II	Recruiting	CEA	-	-	Saccharomyces cerevisiae	s.c.	96

Abbreviations: BCG, bacillus Calmette–Guérin; CEA, carcinoembryonic antigen; EBNA1, Epstein-Barr nuclear antigen 1; EP, electroporation; GUCY2C, guanylyl cyclase 2C; HPV-16, human papillomavirus type 16; i.d., intra dermam; i.m., intra musculum; i.v., intra venam; LMP2, latent membrane protein 2; LTB, E. coli heat labile toxin, B subunit; MAMA, mammaglobin A; MUC1, mucin 1; MVA, modified vaccinia virus Ankara; n.a., not available; PADRE, pan HLA DR-binding epitope; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; TAA, tumor-associated antigen; s.c., sub cutem; TERT, telomerase reverse transcriptase; VRP, virus-like replicon particle. *Published or initiated between 2013, January 1st and the day of submission.

Tiriveedhi V, Fleming TP, Goedegebuure PS, Naughton M, Ma C, Lockhart C, Gao F, Gillanders WE, Mohanakumar T. Mammaglobin-A cDNA vaccination of breast cancer patients induces antigen-specific cytotoxic CD4+ICOShi T cells. Breast Cancer Res Treat 2013; 138:109 - 18; http://dx.doi.org/10.1007/s10549-012-2110-9; PMID: 22678162

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Hui EP, Taylor GS, Jia H, Ma BB, Chan SL, Ho R, Wong WL, Wilson S, Johnson BF, Edwards C, et al. Phase I trial of recombinant modified vaccinia ankara encoding Epstein-Barr viral tumor antigens in nasopharyngeal carcinoma patients. Cancer Res 2013; 73:1676 - 88; http://dx.doi.org/10.1158/0008-5472.CAN-12-2448; PMID: 23348421

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Eriksson F, Tötterman T, Maltais AK, Pisa P, Yachnin J. DNA vaccine coding for the rhesus prostate specific antigen delivered by intradermal electroporation in patients with relapsed prostate cancer. Vaccine 2013; 31:3843 - 8; http://dx.doi.org/10.1016/j.vaccine.2013.06.063; PMID: 23831327

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Slovin SF, Kehoe M, Durso R, Fernandez C, Olson W, Gao JP, Israel R, Scher HI, Morris S. A phase I dose escalation trial of vaccine replicon particles (VRP) expressing prostate-specific membrane antigen (PSMA) in subjects with prostate cancer. Vaccine 2013; 31:943 - 9; http://dx.doi.org/10.1016/j.vaccine.2012.11.096; PMID: 23246260

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Diaz CM, Chiappori A, Aurisicchio L, Bagchi A, Clark J, Dubey S, Fridman A, Fabregas JC, Marshall J, Scarselli E, et al. Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. J Transl Med 2013; 11:62; http://dx.doi.org/10.1186/1479-5876-11-62; PMID: 23497415

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Bilusic M, Heery CR, Arlen PM, Rauckhorst M, Apelian D, Tsang KY, Tucker JA, Jochems C, Schlom J, Gulley JL, et al. Phase I trial of a recombinant yeast-CEA vaccine (GI-6207) in adults with metastatic CEA-expressing carcinoma. Cancer Immunol Immunother 2014; 63:225 - 34; http://dx.doi.org/10.1007/s00262-013-1505-8; PMID: 24327292

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