Table 2.

Summary of treatment-related adverse events

(A) Injection site reactions (per vaccine)
Vaccine 1
Cohort A (n = 30)
Cohort B (n = 20)
Site reactionGrade 1Grade 2Grade 3/4Grade 1Grade 2Grade 3/4
Erythema/induration18801820
Pruritus20001600
Pain/soreness1100700
Vaccine 2
Cohort A (n = 15)
Cohort B (n = 15)
Site reaction
Grade 1
Grade 2
Grade 3/4
Grade 1
Grade 2
Grade 3/4
Erythema/induration11401500
Pruritus800900
Pain/soreness800300
Vaccine 3
Cohort A (n = 9)
Cohort B (n = 10)
Site reaction
Grade 1
Grade 2
Grade 3/4
Grade 1
Grade 2
Grade 3/4
Erythema/induration810910
Pruritus500500
Pain/soreness200200
Vaccine 4
Cohort A (n = 7)
Cohort B (n = 7)
Site reaction
Grade 1
Grade 2
Grade 3/4
Grade 1
Grade 2
Grade 3/4
Erythema/induration500600
Pruritus500600
Pain/soreness000200
Vaccine 5
Cohort A (n = 5)
Cohort B (n = 4)
Site reaction
Grade 1
Grade 2
Grade 3/4
Grade 1
Grade 2
Grade 3/4
Erythema/induration410420
Pruritus500200
Pain/soreness100100
Vaccine 6
Cohort A (n = 3)
Cohort B (n = 4)
Site reaction
Grade 1
Grade 2
Grade 3/4
Grade 1
Grade 2
Grade 3/4
Erythema/induration210400
Pruritus200300
Pain/soreness100000
Vaccine 6
Cohort A (n = 3)
Cohort B (n = 4)
Site reaction
Grade 1
Grade 2
Grade 3/4
Grade 1
Grade 2
Grade 3/4
Erythema/induration210400
Pruritus200300
Pain/soreness100000
(B) All other treatment-related adverse events
Organ classAll grades
Grade 3/4
Cohort A
Cohort B
Total
Cohort A
Cohort B
Total

n = 30 (%)
n = 20 (%)
N = 50 (%)
n = 30 (%)
n = 20 (%)
N = 50 (%)
Metabolism
    Dehydration1 (3.3)0 (0)1 (2)1 (3.3)0 (0)1 (2)
Nervous system
    Dizziness0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
    Headache0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
Vascular
    Hot flashes0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
Gastrointestinal
    Nausea1 (3.3)1 (5)2 (4)0 (0)0 (0)0 (0)
    Vomiting0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
Skin
    Dry skin1 (3.3)0 (0)1 (2)0 (0)0 (0)0 (0)
    Night sweats1 (3.3)1 (5)2 (4)0 (0)0 (0)0 (0)
    Pruritus1 (3.3)1 (5)2 (4)0 (0)0 (0)0 (0)
    Rash1 (3.3)2 (10)3 (6)0 (0)0 (0)0 (0)
    Generalized itching1 (3.3)0 (0)1 (2)0 (0)0 (0)0 (0)
Musculoskeletal
    Arthralgia1 (3.3)2 (10)3 (6)0 (0)0 (0)0 (0)
    Myalgia0 (0)2 (10)2 (4)0 (0)0 (0)0 (0)
    Extremity pain0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
General disorders
    Asthenia6 (20)7 (35)13 (26)1 (10)1 (5)2 (4)
    Chills1 (3.3)5 (25)6 (12)0 (0)0 (0)0 (0)
    Fatigue4 (13.3)2 (10)6 (12)1 (3.3)1 (5)2 (4)
    Inflammation0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
    Injection site discoloration0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
    Injection site vesicles0 (0)1 (5)1 (2)0 (0)0 (0)0 (0)
    Pyrexia5 (16.7)3 (15)8 (16)0 (0)0 (0)0 (0)
    Overall243458325