Table 2.
CD4 <200 cells/mL |
CD4 ≥200 cells/mL |
|||||||
15 μg HA |
30 μg HA |
15 μg HA |
30 μg HA |
|||||
Adverse Event | 1st Dose | 2nd Dose | 1st Dose | 2nd Dose | 1st Dose | 2nd Dose | 1st Dose | 2nd Dose |
Systemic symptoms | ||||||||
≥1 symptom | 14 (40%) | 8 (24%) | 14 (37%) | 9 (27%) | 24 (40%) | 15 (25%) | 24 (39%) | 18 (30%) |
Fevera | 0 | 0 | 0 | 1 (3%) | 0 | 1 (2%) | 0 | 2 (3%) |
Grade≥2 | 0 | 1 (2%) | 0 | |||||
Feverishnessb | 4 (12%) | 3 (9%) | 3 (9%) | 3 (9%) | 7 (12%) | 5 (9%) | 3 (5%) | 7 (12%) |
Grade≥2 | 1 (3%) | 1 (3%) | 1 (3%) | 1 (3%) | 1 (2%) | 2 (4%) | 0 | 4 (7%) |
Malaise | 9 (26%) | 5 (15%) | 10 (28%) | 3 (9%) | 13 (22%) | 9 (16%) | 10 (16%) | 11 (18%) |
Grade≥2 | 3 (9%) | 2 (6%) | 5 (14%) | 1 (3%) | 6 (10%) | 0 | 0 | 8 (13%) |
Myalgia | 5 (14%) | 5 (15%) | 7 (19%) | 4 (12%) | 9 (15%) | 9 (17%) | 13 (22%) | 10 (16%) |
Grade≥2 | 1 (3%) | 2 (6%) | 7 (19%) | 0 | 3 (5%) | 1 (2%) | 1 (2%) | 5 (8%) |
Headache | 7 (20%) | 3 (9%) | 11 (31%) | 7 (21%) | 17 (28%) | 8 (15%) | 15 (25%) | 13 (22%) |
Grade≥2 | 2 (6%) | 0 | 6 (17%) | 0 | 6 (10%) | 0 | 4 (7%) | 5 (9%) |
Nausea | 4 (12%) | 3 (9%) | 3 (9%) | 3 (9%) | 8 (13%) | 4 (8%) | 6 (10%) | 6 (10%) |
Grade≥2 | 1 (3%) | 1 (3%) | 3 (9%) | 1 (3%) | 2 (3%) | 2 (4%) | 2 (3%) | 2 (3%) |
Injection site symptoms | ||||||||
≥1 symptom | 6 (17%) | 3 (9%) | 10 (28%) | 7 (21%) | 21 (32%) | 21 (38%) | 34 (42%) | 25 (40%) |
Grade ≥2 | 1 (3%) | 0 | 0 | 0 | 2 (3%) | 0 | 1 (2%) | 1 (2%) |
Pain | 4 (12%) | 1 (3%) | 7 (19%) | 3 (9%) | 10 (16%) | 7 (13%) | 15 (25%) | 13 (22%) |
Grade ≥2 | 1 (3%) | 0 | 0 | 0 | 2 (3%) | 0 | 1 (2%) | 1 (2%) |
Tenderness | 6 (17%) | 1 (3%) | 7 (19%) | 6 (18%) | 13 (22%) | 10 (18%) | 24 (39%) | 19 (32%) |
Grade ≥2 | 1 (3%) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2%) |
Redness | 2 (6%) | 1 (3%) | 0 | 1 (3%) | 10 (17%) | 11 (20%) | 13 (21%) | 0 |
Grade ≥2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Swelling | 2 (6%) | 0 | 0 | 0 | 7 (12%) | 8 (15%) | 7 (11%) | 0 |
Grade ≥2 | 0 | 0 | 0 | 0 |
Abbreviation: HA, hemagglutinin.
Fever indicates a self-measured oral temperature of at least 38°C.
Feverishness indicates the participants’ self-reported sense of feverishness.