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Table 3 Grade 1 or 2 injection site reactions (incidence ≥1% in one or more treatment groups)

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

Adverse event, n (%)

Study 1

Study 2a

 

V930 DNA-EP

V930 DNA-EP

V932 Ad

V932 Ad

 

0.25 mg

2.5 mg

0.5 × 109vg/injection

0.5 × 1011vg/injection

 

(n=6)

(n=22)

(n=6)

(n=5)

Injection site erythema

1 (17)

14 (64)

0

3 (60)

Injection site pain

4 (67)

9 (41)

1 (17)

4 (80)

Injection site swelling

1 (17)

8 (36)

1 (17)

2 (40)

Injection site bruising

1 (17)

1(5)

0

0

Injection site papule

0

1(5)

0

0

Injection site rash

0

1(5)

0

1 (20)

  1. 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.