AEs to Triplex in all vaccinated subjects
. | DL1 . | DL2 . | DL3 . | . | |||
---|---|---|---|---|---|---|---|
AE* . | 1&2 . | 3 . | 1&2 . | 3 . | 1&2 . | 3 . | % total . |
Local | |||||||
Erythema | 0 | 0 | 0 | 0 | 0 | 1 | 4 |
Induration | 0 | 0 | 1 | 0 | 1 | 0 | 8 |
Paresthesia | 0 | 0 | 0 | 0 | 1 | 0 | 4 |
Systemic | |||||||
Fatigue | 0 | 0 | 1 | 0 | 8 | 0 | 38 |
Hyperbilirubinemia | 1 | 0 | 0 | 0 | 0 | 0 | 4 |
Myalgia | 2 | 0 | 1 | 0 | 7 | 0 | 42 |
Hypertension | 0 | 0 | 0 | 0 | 1 | 0 | 4 |
Nausea | 0 | 0 | 0 | 0 | 2 | 0 | 8 |
Cough | 1 | 0 | 0 | 0 | 0 | 0 | 4 |
Headache | 1 | 0 | 2 | 0 | 5 | 0 | 33 |
. | DL1 . | DL2 . | DL3 . | . | |||
---|---|---|---|---|---|---|---|
AE* . | 1&2 . | 3 . | 1&2 . | 3 . | 1&2 . | 3 . | % total . |
Local | |||||||
Erythema | 0 | 0 | 0 | 0 | 0 | 1 | 4 |
Induration | 0 | 0 | 1 | 0 | 1 | 0 | 8 |
Paresthesia | 0 | 0 | 0 | 0 | 1 | 0 | 4 |
Systemic | |||||||
Fatigue | 0 | 0 | 1 | 0 | 8 | 0 | 38 |
Hyperbilirubinemia | 1 | 0 | 0 | 0 | 0 | 0 | 4 |
Myalgia | 2 | 0 | 1 | 0 | 7 | 0 | 42 |
Hypertension | 0 | 0 | 0 | 0 | 1 | 0 | 4 |
Nausea | 0 | 0 | 0 | 0 | 2 | 0 | 8 |
Cough | 1 | 0 | 0 | 0 | 0 | 0 | 4 |
Headache | 1 | 0 | 2 | 0 | 5 | 0 | 33 |
AEs were listed accordingly to the HIV Vaccine Trials Network/Division of AIDS intensity grading scale as: grade 1 = mild; grade 2 = moderate; grade 3 = severe; grade 4 = life-threatening. The table shows the number of volunteers who experienced grade 1 & 2, or 3 local or systemic AEs (listed in the left column, according to the HTVN intensity grading scale) for each vaccine DL (as specified in Table 2) cohort (N = 8) indicated in the boxes. No toxicity grade 4 AE was reported. Last column shows the percentages of the total post-vaccination–related AEs. AEs that were considered unrelated or unlikely to be related to the investigational agent are not shown.