Table 2. Immunized cohort CA (solicited AEs): Numbers of volunteers experiencing local, and systemic adverse events (days 0–7 post each immunization)1,2.
Sign or Symptom | DNA 1 (n = 20) (% of vol’s) | DNA 2 (n = 20) (% of vol’s) | DNA 3 (n = 20) (% of vol’s) | ChAd (n = 19) (% of vol’s) | Total AE’s (% of all AE’s) | ||||
---|---|---|---|---|---|---|---|---|---|
Gr1 | Gr2/3 | Gr1 | Gr2/3 | Gr1 | Gr2/3 | Gr1 | Gr2/3 | ||
LOCAL | |||||||||
Ecchymosis | 3(15%) | 0 | 4(20%) | 0 | 4(20%) | 0 | 2(11%)3 | 0 | 14(14%) |
Induration | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pain | 4(20%) | 0 | 5(25%) | 1(5%) | 7(35%) | 0 | 5(26%) | 2(11%) | 29(28%) |
Parasthesia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pruritus | 1(5%) | 0 | 2(10%) | 1(5%) | 2(10%) | 0 | 0 | 0 | 6(6%) |
Redness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Scaling | 0 | 0 | 0 | 0 | 1(5%) | 0 | 0 | 0 | 1(1%) |
Swelling | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Tenderness | 9(45%) | 0 | 11(55%) | 1(5%) | 7(35%) | 0 | 9(47%) | 2(11%)3 | 45(44%) |
Warmth | 2(10%) | 0 | 3(15%) | 0 | 1(5%) | 0 | 0 | 0 | 7(7%) |
Total Local AEs | 24 | 0 | 33 | 3 | 22 | 0 | 16 | 4 | 102 (55%) |
SYSTEMIC | |||||||||
Abdominal Pain | 0 | 0 | 0 | 0 | 0 | 0 | 1(5%) | 1(5%) | 2(2%) |
Arthralgia | 1(5%) | 0 | 0 | 0 | 0 | 0 | 1(5%) | 1(5%)3 | 3(4%) |
Chills | 0 | 0 | 0 | 0 | 0 | 0 | 1(5%) | 6(32%)3 | 8(10%) |
Cough | 2(10%) | 0 | 0 | 1(5%) | 2(10%) | 0 | 1(5%) | 0 | 7(8%) |
Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dizziness | 0 | 0 | 0 | 0 | 0 | 0 | 2(11%) | 2(11%)3 | 4(5%) |
Fatigue | 0 | 1(5%) | 2(10%) | 1(5%) | 0 | 0 | 4(21%) | 6(32%)5 | 15(18%) |
Fever | 0 | 0 | 0 | 0 | 0 | 0 | 2(11%) | 1(5%)3 | 3(4%) |
Flu-like illness | 0 | 0 | 0 | 1(5%) | 1(5%) | 1(5%) | 1(5%) | 3(16%)3 | 7(8%) |
Headache | 2(10%) | 0 | 2(10%) | 0 | 0 | 1(5%) | 3(15%) | 5(26%)3 | 14(17%) |
Malaise | 0 | 0 | 0 | 0 | 0 | 0 | 2(11%) | 4(21%)3 | 6(7%) |
Myalgia | 2(10%) | 1(5%) | 0 | 0 | 0 | 0 | 1(5%) | 3(16%)3 | 9(11%) |
Nausea | 1(5%) | 0 | 0 | 0 | 0 | 1(5%) | 0 | 1(5%)4 | 3(4%) |
Regional adenopathy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Rigors | 0 | 0 | 0 | 0 | 0 | 0 | 1(5%) | 0 | 1(1%) |
Vomiting | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(5%)4 | 1(1%) |
Total Systemic AEs | 11 | 4 | 4 | 3 | 3 | 3 | 21 | 34 | 83(45%) |
Total All AEs | 35 | 4 | 37 | 6 | 25 | 3 | 37 | 38 | 185(100%) |