Table 2.

Proportions of subjects reporting solicited reactions after any vaccination

Cohort 1Cohort 2Cohort 3Cohort 4
Open-labelOpen-labelRandomized, double-blindedOpen-label
GTL001 100 μg solution + imiquimodGTL001 solution 600 μg + imiquimodGTL001 solution 600 μg + imiquimodGTL001 solution 600 μg + placeboPlacebo injection + imiquimodGTL001 600 μg powder + imiquimod
ReactionN = 5N = 5N = 14N = 7N = 7N = 9
Injection site
 Pain
  Grade 10 (0.0)0 (0.0)1 (7.1)0 (0.0)1 (14.3)0 (0.0)
  Grade 24 (80.0)5 (100.0)9 (64.3)6 (85.7)0 (0.0)4 (44.4)
  Grade 31 (20.0)0 (0.0)3 (21.4)1 (14.3)0 (0.0)4 (44.4)
 Tenderness
  Grade 10 (0.0)0 (0.0)1 (7.1)2 (28.6)2 (28.6)1 (11.1)
  Grade 24 (80.0)5 (100.0)9 (64.3)3 (42.9)0 (0.0)6 (66.7)
  Grade 31 (20.0)0 (0.0)4 (28.6)2 (28.6)0 (0.0)2 (22.2)
 Erythema
  Grade 10 (0.0)1 (20.0)2 (14.3)1 (14.3)0 (0.0)0 (0.0)
  Grade 24 (80.0)4 (80.0)10 (71.4)6 (85.7)0 (0.0)5 (55.6)
  Grade 30 (0.0)0 (0.0)2 (14.3)0 (0.0)0 (0.0)4 (44.4)
 Swelling
  Grade 12 (40.0)2 (40.0)4 (28.6)4 (57.1)0 (0.0)2 (22.2)
  Grade 21 (20.0)2 (40.0)6 (42.9)3 (42.9)0 (0.0)6 (66.7)
  Grade 31 (20.0)1 (20.0)2 (14.3)0 (0.0)0 (0.0)0 (0.0)
 Induration
  Grade 11 (20.0)3 (60.0)3 (21.4)4 (57.1)0 (0.0)2 (22.2)
  Grade 22 (40.0)2 (40.0)8 (57.1)2 (28.6)0 (0.0)5 (55.6)
  Grade 30 (0.0)0 (0.0)1 (7.1)0 (0.0)0 (0.0)1 (11.1)
 Ulceration
  Grade 10 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  Grade 20 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  Grade 30 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Scabs
  Grade 10 (0.0)2 (40.0)2 (14.3)0 (0.0)0 (0.0)0 (0.0)
  Grade 20 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  Grade 30 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Itching
  Grade 13 (60.0)4 (80.0)9 (64.3)2 (28.6)1 (14.3)8 (88.9)
  Grade 22 (40.0)1 (20.0)4 (28.6)4 (57.1)0 (0.0)1 (11.1)
  Grade 30 (0.0)0 (0.0)1 (7.1)1 (14.3)0 (0.0)0 (0.0)
Systemic
 Arthralgia
  Grade 10 (0.0)2 (40.0)0 (0.0)1 (14.3)1 (14.3)4 (44.4)
  Grade 20 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  Grade 30 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Myalgia
  Grade 12 (40.0)3 (60.0)4 (28.6)1 (14.3)1 (14.3)1 (11.1)
  Grade 20 (0.0)1 (20.0)2 (14.3)3 (42.9)0 (0.0)3 (33.3)
  Grade 31 (20.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Headache
  Grade 11 (20.0)1 (20.0)8 (57.1)2 (28.6)3 (42.9)4 (44.4)
  Grade 22 (40.0)1 (20.0)3 (21.4)3 (42.9)1 (14.3)2 (22.2)
  Grade 30 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Fatigue
  Grade 14 (80.0)2 (40.0)7 (50.0)4 (57.1)4 (57.1)2 (22.2)
  Grade 20 (0.0)1 (20.0)3 (21.4)1 (14.3)0 (0.0)2 (22.2)
  Grade 31 (20.0)0 (0.0)0 (0.0)2 (28.6)0 (0.0)0 (0.0)
 Nausea
  Grade 12 (40.0)1 (20.0)5 (35.7)1 (14.3)2 (28.6)3 (33.3)
  Grade 20 (0.0)0 (0.0)1 (7.1)2 (28.6)0 (0.0)0 (0.0)
  Grade 30 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Fever
  Grade 10 (0.0)0 (0.0)0 (0.0)1 (14.3)0 (0.0)0 (0.0)
  Grade 21 (20.0)0 (0.0)1 (20.0)0 (0.0)0 (0.0)0 (0.0)
  Grade 30 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
 Rigors
  Grade 10 (0.0)0 (0.0)3 (21.4)3 (42.9)0 (0.0)2 (22.2)
  Grade 21 (20.0)0 (0.0)1 (7.1)1 (14.3)1 (14.3)1 (11.1)
  Grade 30 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  • NOTE: Values are for the safety population and are the number of subjects with the percentage in brackets.