Table 3. Immunized cohort CAT (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 = 18) (% of vol’s) | ChAd (n = 16) (% of vol’s) | Total AE’s (% of all AE’s) | ||||
|---|---|---|---|---|---|---|---|---|---|
| Gr1 | Gr2/3 | Gr1 | Gr2/3 | Gr1 | Gr2/3 | Gr1 | Gr2/3 | ||
| LOCAL | |||||||||
| Ecchymosis | 2(10%) | 0 | 3(15%) | 0 | 1(6%) | 0 | 1(6%) | 0 | 7(9%) |
| Induration | 0 | 0 | 1(5%) | 0 | 1(6%) | 0 | 0 | 0 | 2(3%) |
| Pain | 5(25%) | 0 | 2(10%) | 0 | 3(17%) | 0 | 4(24%) | 4(24%)4 | 20(25%) |
| Parasthesia | 0 | 0 | 1(5%) | 0 | 0 | 0 | 1(6%) | 0 | 2(3%) |
| Pruritus | 1(5%) | 0 | 3(15%) | 0 | 0 | 0 | 0 | 0 | 4(5%) |
| Redness | 0 | 0 | 0 | 0 | 1(6%) | 0 | 3(18%) | 0 | 4(5%) |
| Scaling | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Swelling | 0 | 0 | 0 | 0 | 0 | 0 | 2(12%) | 0 | 2(3%) |
| Tenderness | 10(50%) | 1(5%) | 4(20%) | 0 | 7(39%) | 0 | 5(29%) | 3(18%)4 | 34(43%) |
| Warmth | 1(5%) | 0 | 1(5%) | 0 | 0 | 0 | 2(12%) | 0 | 4(5%) |
| Total Local AEs | 21 | 1 | 18 | 0 | 13 | 0 | 19 | 7 | 79(39%) |
| SYSTEMIC | |||||||||
| Abdominal Pain | 1(5%) | 0 | 0 | 0 | 0 | 0 | 2(12%) | 0 | 3(2%) |
| Arthralgia | 0 | 0 | 1(5%) | 0 | 0 | 0 | 0 | 6(35%)2 | 8(6%) |
| Chills | 0 | 0 | 1(5%) | 0 | 0 | 0 | 3(18%) | 7(41%)2,6 | 13(10%) |
| Cough | 0 | 0 | 1(5%) | 0 | 1(6%) | 0 | 1(6%) | 2(29)3 | 5(4%) |
| Diarrhea | 1(5%) | 0 | 0 | 0 | 0 | 0 | 0 | 1(6%)3 | 2(2%) |
| Dizziness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1(6%)3 | 1(1%) |
| Fatigue | 2(10%) | 0 | 2(10%) | 1(5%) | 2(11%) | 0 | 0 | 6(35%)5 | 15(12%) |
| Fever | 0 | 0 | 1(5%) | 0 | 0 | 0 | 1(6%) | 5(29%)5 | 8(6%) |
| Flu-like illness | 1(5%) | 0 | 0 | 0 | 0 | 0 | 0 | 5(29%)5 | 7(6%) |
| Headache | 4(20%) | 0 | 1(5%) | 0 | 2(11%) | 0 | 3(18%) | 8(47%)5 | 21(17%) |
| Malaise | 1(5%) | 0 | 1(5%) | 0 | 2(11%) | 0 | 0 | 6(35%)5 | 11(9%) |
| Myalgia | 2(10%) | 0 | 2(10%) | 0 | 0 | 0 | 0 | 10(59%)5 | 15(12%) |
| Nausea | 0 | 0 | 1(5%) | 0 | 0 | 0 | 1(6%) | 2(12%)3 | 5(4%) |
| Regional adenopathy | 1(5%) | 0 | 1(5%) | 0 | 0 | 0 | 1(6%) | 0 | 3(2%) |
| Rigors | 0 | 0 | 0 | 0 | 0 | 0 | 1(6%) | 2(12%)4 | 4(3%) |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 1(6%) | 1(6%) | 1(6%)3 | 4(3%) |
| Total Systemic AEs | 13 | 0 | 14 | 4 | 7 | 1 | 15 | 71 | 125 (61%) |
| Total All AEs | 34 | 1 | 32 | 4 | 20 | 1 | 34 | 78 | 204 (100%) |
Solicited local and systemic adverse events were assessed starting on day of immunization (following receipt of vaccine) through 7 days post-immunization (Day 7). AEs: Adverse Events; vols (volunteers); Gr (Grade) Severity classification for signs and symptoms: Gr1 = adverse event does not interfere with daily activities; Gr2 = interferes with but does not prevent daily activities; Gr3 = prevents daily activities. All adverse events in the table are Gr1 (mild) unless noted otherwise.
1The local and systemic AEs are tabulated by subjects experiencing the AE according to their highest grade recorded in days 0–7 For those that experienced multiple events for a specific AE at a specific dose, the most severe event was used.
2The total AE’s is the total number of all adverse events (i.e., subjects may have exhibited the same AE at a specific dose more than once).
3 = Gr2 (moderate);
4 = Gr3 (severe);
5 = both Gr2 and Gr3.
All local adverse events occurred in the arm ipsilateral to the injection site.
6 Includes an isolated grade 4 event (resolved).