Table 2. Adverse Reactions After 3 Doses in the Phase 1 Trial and 2 Doses in the Phase 2 Trial in the Safety Seta.
| Adverse reaction | Phase 1 clinical trial; 0, 28, and 56–d group |
Phase 2 clinical trial | ||||||
|---|---|---|---|---|---|---|---|---|
| 0 and 14–d Group | 0 and 21–d Group | |||||||
| Low dose (n = 24) | Medium dose (n = 24) | High dose (n = 24) | Alum only (n = 24) | Medium dose (n = 84) | Alum only (n = 28) | Medium dose (n = 84) | Alum only (n = 28) | |
| 0-7 d | ||||||||
| Total adverse reactions | 5 (20.8) | 4 (16.7) | 6 (25.0) | 3 (12.5) | 5 (6.0) | 4 (14.3) | 16 (19.0) | 5 (17.9) |
| Systemic reactions | 0 | 3 (12.5) | 1 (4.2) | 1 (4.2) | 4 (4.8) | 2 (7.1) | 4 (4.8) | 2 (7.1) |
| Coughing | 0 | 0 | 0 | 0 | 1 (1.2) | 0 | 0 | 0 |
| Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.2) | 0 |
| Fatigue | 0 | 1 (4.2) | 0 | 0 | 1 (1.2) | 0 | 0 | 0 |
| Fever | 0 | 1 (4.2) | 1 (4.2) | 0 | 4 (4.8) | 1 (3.6) | 2 (2.4) | 1 (3.6) |
| Headache | 0 | 0 | 0 | 0 | 1 (1.2) | 1 (3.6) | 0 | 1 (3.6) |
| Nausea and vomiting | 0 | 1 (4.2) | 0 | 1 (4.2) | 0 | 0 | 1 (1.2) | 1 (3.6) |
| Pruritus (noninoculated site) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.6) |
| Local reactions | 5 (20.8) | 1 (4.2) | 6 (25.0) | 2 (8.3) | 2 (2.4) | 3 (10.7) | 13 (15.5) | 4 (14.3) |
| Itching | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1.2) | 1 (3.6) |
| Pain | 5 (20.8) | 1 (4.2) | 6 (25.0) | 2 (8.3) | 2 (2.4) | 3 (10.7) | 12 (14.3) | 4 (14.3) |
| Redness | 0 | 0 | 1 (4.2) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Swelling | 1 (4.2) | 0 | 1 (4.2) | 0 | 0 | 0 | 1 (1.2) | 1 (3.6) |
| Other reactions | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 0-28 d | ||||||||
| Total adverse reactions | 5 (20.8) | 4 (16.7) | 6 (25.0) | 3 (12.5) | 5 (6.0) | 4 (14.3) | 16 (19.0) | 5 (17.9) |
Abbreviation: alum, aluminum hydroxide.
The safety set included all participants who received at least 1 dose. The low, medium, and high doses represent 2.5, 5, and 10 μg/dose, respectively. Data are shown as No. of participants with event (%). A participant was only counted once in the specific reaction category even though a participant could have more than 1 adverse reaction. For example, a participant who had the same symptom (eg, injection site pain) after each dose was counted once in the symptom category. Similarly, if a participant had more than 1 symptom in the reaction class (total, systemic, and local), they were only counted once in that adverse reaction class. Detailed adverse reactions after each dose are shown in eTable 2 in Supplement 3.