Table 3 Adverse events within 28 days after each vaccination
From: Safety and immunogenicity of an HIV vaccine trial with DNA prime and replicating vaccinia boost
Ia | Ib | |||||
|---|---|---|---|---|---|---|
rTV-L (n = 6) | rTV-H (n = 6) | DNA-L/ rTV (n = 12) | DNA-H/ rTV (n = 12) | DNA (n = 6) | Placebo (n = 6) | |
Reactogenicity | ||||||
Local adverse reactions | ||||||
Redness | 0 (.) | 0 (.) | 1 (8%) | 6 (50%) | 0 (.) | 0 (.) |
Papule | 0 (.) | 0 (.) | 6 (50%) | 3 (25%) | 0 (.) | 0 (.) |
Systemic Reactogenicity events | ||||||
Lymph node enlargement, with or without tenderness | 4 (67%) | 4 (67%) | 4 (33%) | 1(8%) | 0 (.) | 1(17%) |
Fevera | 1 (17%) | 1 (17%) | 0 (.) | 0 (.) | 0 (.) | 0 (.) |
Headache | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 1 (17%) | 0 (.) |
Arthralgia | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 1 (17%) |
Unexpected AEs | ||||||
Upper respiratory infection | 1 (17%) | 0 (.) | 4 (33%) | 6 (50%) | 1 (17%) | 1 (17%) |
Dizzy | 0 (.) | 1 (17%) | 0 (.) | 1(8%) | 0 (.) | 0 (.) |
Rash | 0 (.) | 0 (.) | 0 (.) | 1(8%) | 0 (.) | 0 (.) |
Acute tonsilitis | 1 (17%) | 0 (.) | 0 (.) | 1(8%) | 0 (.) | 0 (.) |
Mouth ulcer | 1 (17%) | 0 (.) | 0 (.) | 1(8%) | 0 (.) | 0 (.) |
Injury | 1 (17%) | 0 (.) | 0 (.) | 1(8%) | 0 (.) | 0 (.) |
Cough | 0 (.) | 0 (.) | 0 (.) | 1(8%) | 0 (.) | 0 (.) |
Pharyngitis | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 1 (17%) |
Pericoronitis | 0 (.) | 0 (.) | 1 (8%) | 0 (.) | 0 (.) | 0 (.) |
Tympanitis | 0 (.) | 0 (.) | 0 (.) | 1 (8%) | 0 (.) | 0 (.) |
Chronic gastritis | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 1 (17%) | 0 (.) |
Stomachache | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 1 (17%) |
Toothache | 0 (.) | 0 (.) | 0 (.) | 0 (.) | 1 (17%) | 0 (.) |
CK elevation | 2 (33%) | 1(17%) | 0 (.) | 0 (.) | 0 (.) | 0 (.) |
Leukopenia | 0 (.) | 0 (.) | 0 (.) | 1 (8%) | 0 (.) | 0 (.) |
ANA (1:160) | 0 (.) | 0 (.) | 1 (8%) | 1 (8%) | 1 (17%) | 0 (.) |
