Table 2.
Number of volunteers reporting vaccine-related adverse events in experimental and control groups.
| Adverse eventsa | Group | Phase IIa | Phase IIb | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Naive (n = 11) | Control (n = 5) | Semi-immune (n = 11) | Control (n = 5) | ||||||||||
| Doses | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
| Local | |||||||||||||
| Injection site pain | 5 | 4 | 5 | 3 | 2 | 3 | 1 | 3 | 3 | 1 | 2 | ||
| Swelling | 1 | 1 | |||||||||||
| Systemic | |||||||||||||
| Headache | 2 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | ||||
| Malaise | 3 | 1 | 2 | 1 | 2 | 1 | |||||||
| Fever | 2 | 2 | 1 | 1 | |||||||||
| Nausea/Emesis | 2 | 1 | 2 | ||||||||||
| Chills | 2 | ||||||||||||
| Diarrhea | 3 | 1 | 1 | ||||||||||
| Abdominal pain | 1 | 1 | |||||||||||
The number of individuals in phases IIa and IIb study groups who developed local and systemic Adverse Events (AE) in Exp (n = 11) and Ctrl (n = 5) volunteers is indicated. Transient (1 day) pain at injection site (75%) and headache and malaise (31.25%) were observed with mild (grade 1) to moderate (grade 2) intensity.
aAll AE were graded I–II.