Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors

Table 2 Grade 1 or 2 adverse events occurring in at least 2 patients

Adverse event, n (%)	Study 1		Study 2^a
	V930 DNA-EP^b	V930 DNA-EP^b	V932 Ad^c	V932 Ad^c
	0.25 mg	2.5 mg	0.5 × 10⁹	0.5 × 10¹¹
			vg/injection	vg/injection
	(n=6)	(n=22)	(n=6)	(n=5)
Diarrhea	2 (33)	5 (23)	0	0
Fatigue	1 (17)	5 (23)	1 (17)	1 (20)
Arthralgias	1 (17)	3 (14)	2 (33)	0
Nausea	0	4 (18)	0	0
Skin & subcutaneous tissue disorders	1 (17)	3 (14)	1 (17)	1 (20)
Abdominal pain	0	3^a (14)	0	0
Infections	0	3 (14)	1 (17)	0
Insomnia	1 (17)	2 (9)	0	0
Constipation	0	2 (9)	0	0
Dizziness	0	2 (9)	1 (17)	0
Dyspnea	0	4 (18)	1 (17)	0
Hot flushes	0	2 (9)	0	0
Musculoskeletal pain	0	2 (9)	4 (67)	4^b (80)
Vomiting	0	2 (9)	0	0
Creatinine elevation (grade 1)	0	1 (5)	0	2 (40)

^aSix eligible patients from Study 1 were enrolled into Study 2. Therefore, only 5 patients that had not previously participated in Study 1 were enrolled into Study 2. Overall 33 patients (not 39) were enrolled in both studies.
^bAll adverse events with DNA vaccine alone (V930 DNA-EP) were Grade 1-2, with the exception of one case of grade 3 abdominal pain felt to be unrelated to study drug in the treatment phase and one case of grade 3 abdominal pain due to small bowel obstruction in the follow-up phase believed to be related to the tumor and not related to study drug.
^cAll averse events with V930 DNA-EP→V932Ad were grades 1 or 2, with the exception of one patient who experienced grade 3 muscle spasm in the low-dose V932 Ad group and one patient with ankle pain and unilateral leg pain in the high-dose V932Ad group. Both were not related to the study drug, as determined by the investigator.

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