Table 2.

HER2-specific vaccines in the clinic. More details on clinical trials are available at http://www.clinicaltrials.gov

Vaccine strategy	Vector	Immunogen	Phase	Recruitment status	Indications	Reference	Investigators	Reference
Cancer cell-based vaccine	SVBR-1 breast cancer cells	Cells transfected with GM-CSF plus interferon-alpha	I/II	Recruiting	Stage IV breast cancer	NCT00095862	C.L. Wiseman, Wiseman Research Initiatives
	SKBR3 breast cancer cell line	Cells transfected with GM-CSF plus cyclophosphamide and doxorubicin	I	Active, not recruiting	Stage IV breast cancer	NCT00093834	L.A. Emens, Sidney Kimmel Comprehensive Cancer Center	[107]
		Cells transfected with GM-CSF plus cyclophosphamide and trastuzumab	II	Recruiting	Metastatic breast cancer	NCT00397371	L.A. Emens, Sidney Kimmel Comprehensive Cancer Center
			II	Active, not recruiting	Metastatic breast cancer	NCT00399529	L.A. Emens, Sidney Kimmel Comprehensive Cancer Center
		Cells transfected with GM-CSF plus cyclophosphamide, with or without trastuzumab	II	Recruiting	Metastatic breast cancer	NCT00971737	L.A. Emens, Sidney Kimmel Comprehensive Cancer Center
		Cells transfected with GM-CSF plus cyclophosphamide and trastuzumab	II	Recruiting	High risk of metastatic breast cancer	NCT00847171	L.A. Emens, Sidney Kimmel Comprehensive Cancer Center
DC-based vaccine	CD34+ autologous dendritic cells	DC-transduced HER2-expressing adenovirus	I	Recruiting	Metastatic breast cancer	NCT00197522 NCT00162929	M. Levine, Ontario Clinical Oncology Group
	CD34+ autologous dendritic cells	DC-pulsed E75 and E90 peptides plus trastuzumab and vinorelbine	II	Recruiting	Metastatic breast cancer (HLA-A0201)	NCT00266110	J.S. Serody, Lineberger Comprehensive Cancer Center
	Dendritic cells 1 (DC1)	DC-pulsed HER2 peptides 369–377 and 689–697	I/II	Recruiting	Ductal breast carcinoma	NCT00923143 NCT00107211	B.J. Czerniecki, Abramson Cancer Center	[45]
DNA-based vaccine	Non replicating vaccinia virus	DNA coding for the HER2 extracellular domain which includes two universal epitopes from the tetanus toxin	I	Active, not recruiting	HER2-positive metastatic breast cancer	NCT00485277	W. Godfrey, BN ImmunoTherapeutics
	Plasmid	DNA coding for the HER2 peptide (V930)	I	Completed	Stage II/III/IV breast, colorectal, ovarian, non-small lung cancers	NCT00250419	Merck
		DNA coding for the HER2 and CEA peptides (V930 plus V932)	I	Completed	HER2- and/or CEA-expressing cancers	NCT00647114	Merck
	pNGVL3 plasmid	DNA coding for the HER2 intracellular domain		Recruiting	Stage III/IV breast cancer	NCT00363012	L.G. Lazar, Fred Hutchinson Cancer Center
	Adenovirus	DNA coding for rat HER2	I	Active, not recruiting	Metastatic breast cancer	NCT00307229	M. Levine, Ontario Clinical Oncology Group
	pNGVL3 plasmid	DNA coding for the HER2 intracellular domain plus GM-CSF	I	Active, not recruiting	Stage III/IV breast or ovarian cancer	NCT00436254	M.N.L. Disis, University of Washington
HER2-derived peptides	PolyLactideGlycolide microspheres	HER2 peptide 369–377 plus GM-CSF	I	Completed	Stage III/IV breast, ovarian or non-small cell lung cancer	NCT00005023	M.N.L. Disis, University of Washington
		Peptide of the HER2 intracellular domain (Th epitopes) plus GM-CSF	I	Active, not recruiting	Stage III/IV breast, ovarian or non-small cell lung cancer	NCT00003002	M.N.L. Disis, University of Washington	[56, 57]
		HER2 CTL peptide plus trastuzumab	I/II	Active, not recruiting	Stage III/IV breast or ovarian cancer	NCT00194714	M.N.L. Disis, University of Washington	[112]
	HER2 peptide-stimulated and ex vivo expanded cells	Autologous HER2-specific T cells	I	Recruiting	Metatstatic breast, ovarian or non-small cell lung cancer	NCT00228358	M.N.L. Disis, University of Washington
		Peptides from the HER2 intracellular domain (p369, p688, p971)	II	Recruiting	Trastuzumab-treated stage IIIB/IIIC/IV breast cancer	NCT00343109	M.N.L. Disis, University of Washington
	HER2 peptide-stimulated and ex vivo expanded cells	Peptide from the HER2 intracellular domain (Th epitopes) plus GM-CSF and autologous HER2-specific T cells plus trastuzumab	I/II	Recruiting	Stage IV breast cancer	NCT00791037	M.N.L. Disis, University of Washington
		The HER2 peptide GP2 or AE37 plus GM-CSF	II	Recruiting	Node-positive breast cancer (HLA-A2)	NCT00524277	G.E. Peoples, Walter Reed Army Medical Center	[62]
		The HER2 peptide E75 plus GM-CSF	I/II	Active, not recruiting	Node-negative breast cancer (HLA-A2 and/or -A3)	NCT00854789	G.E. Peoples, Walter Reed Army Medical Center
		The HER2 peptide E75 plus GM-CSF	I/II	Active, not recruiting	Node-positive breast cancer (HLA-A2 and/or -A3)	NCT00841399	G.E. Peoples, Walter Reed Army Medical Center
		Two HER2 peptides and the MUC1 antigen plus GM-CSF and/or a CpG oligodoxynucleotide	II	Recruiting	Stage II/III breast cancer	NCT00640861	S.J. Gendler, Mayo Clinic Scottsdale
		The HER2 peptide AUTOVAC (PX104.1.6)	I	Completed	Breast cancer	NCT00068614	B.A. Overmoyer, Case Comprehensive Cancer Center
		Nine peptides from HER2, CEA and CTA		Recruiting	Breast cancer	NCT00892567	D.R. Brenin, University of Virginia
		HER2 and CEA peptides plus GM-CSF and the adjuvant ISA-51	I	Active, not recruiting	Stage IIB/III/IV colorectal cancer (HLA-A2 or -A3)	NCT00091286	C.M. Friel, University of Virginia
		369-377/754-762 HER2, MAGE-A1 and FBP peptides plus tetanus toxoid helper peptide plus carboplatin and paclitaxel	II	Active, not recruiting	Stage III/IV ovarian, primary peritoneal or fallopian cancer	NCT00373217	A.A. Jazaeri, University of Virginia
		HER2 (628-647) B-cell epitope and MVF T-helper epitope plus co-polymer CRL1005	IB	Active, not recruiting	Metastatic or recurrent breast, gastric, lung and ovarian cancer	NCT00017537	P.L. Triozzi, University of Alabama	[77]
HER2 protein		Cholesterol-bearing hydrophobized HER2 protein 146 plus NY-ESO-1 and Picibanil	I	Completed	Esophageal, lung, stomach, breast and ovarian cancer	NCT00291473	H. Shiku, Mie University/Ludwig Institute
		dHER2 protein plus the AS15 liposome adjuvant	I	Completed	HER2-positive metastatic breast cancer	NCT00140738	Glaxo SmithKline
		dHER2 protein plus the AS15 liposome adjuvant	I	Active, not recruiting	High-risk breast cancer	NCT00140738	Glaxo SmithKline
		dHER2 protein plus the AS15 liposome adjuvant and lapatinib	I/II	Recruiting	Metastatic breast cancer	NCT00952692	M. Morse, Glaxo SmithKline