Table 3.
Safety End Points.*
| Event | Participants with an Event after Dose 1 | Participants with an Event after Dose 2 | Participants with an Eventafter Either Dose | |||
|---|---|---|---|---|---|---|
| no./total no. | % (95% CI) | no./total no. | % (95% CI) | no./total no. | % (95% CI) | |
| Vaccine- or placebo-related serious adverse event | ||||||
| Vaccine | 0/274 | 0 (0–1) | 0/228 | 0 (0–2) | 0/274 | 0 (0–1) |
| Placebo | 0/272 | 0 (0–1) | 0/227 | 0 (0–2) | 0/272 | 0 (0–1) |
| Severe solicited local adverse event†‡ | ||||||
| Vaccine | 0/274 | 0 (0–1) | 1/228 | <1 (0–2) | 1/274 | <1 (0–2) |
| Placebo | 0/272 | 0 (0–1) | 0/227 | 0 (0–2) | 0/272 | 0 (0–1) |
| Severe solicited systemic adverse event†§ | ||||||
| Vaccine | 0/274 | 0 (0–1) | 1/228 | <1 (0–2) | 1/274 | <1 (0–2) |
| Placebo | 0/272 | 0 (0–1) | 0/227 | 0 (0–2) | 0/272 | 0 (0–1) |
| Any laboratory adverse event | ||||||
| Vaccine | 70/258 | 27 (22–33) | 73/220 | 33 (27–40) | 102/262 | 39 (33–45) |
| Placebo | 48/259 | 19 (14–24) | 49/224 | 22 (17–28) | 76/261 | 29 (24–35) |
| Grade 3 or 4 laboratory adverse events | ||||||
| Increase in ALT level¶ | ||||||
| HCV infected | ||||||
| Vaccine | 1/4 | 25 (1–75) | 4/8 | 50 (19–81) | 4/8 | 50 (19–81) |
| Placebo | 0/5 | 0 (50–100) | 3/9 | 33 (10–68) | 3/10 | 30 (9–62) |
| HCV uninfected | ||||||
| Vaccine | 1/258 | <1 (0–2) | 0/213 | 0 (0–2) | 1/262 | <1 (0–2) |
| Placebo | 0/258 | 0 (0–1) | 0/217 | <1 (0–2) | 1/260 | <1 (0–2) |
| Increase in creatinine level | ||||||
| Vaccine | 0/258 | 0 (0–1) | 0/220 | 0 (0–2) | 0/262 | 0 (0–1) |
| Placebo | 0/259 | 0 (0–1) | 0/224 | 0 (0–2) | 0/261 | 0 (0–1) |
| Decrease in hemoglobin level | ||||||
| Vaccine | 0/258 | 0 (0–1) | 0/220 | 0 (0–2) | 0/262 | 0 (0–1) |
| Placebo | 0/259 | 0 (0–1) | 0/224 | 0 (0–2) | 0/261 | 0 (0–1) |
| Increase in white-cell count | ||||||
| Vaccine | 0/258 | 0 (0–1) | 0/220 | 0 (0–2) | 0/262 | 0 (0–1) |
| Placebo | 0/259 | 0 (0–1) | 0/224 | 0 (0–2) | 0/261 | 0 (0–1) |
| Decrease in platelet count | ||||||
| Vaccine | 1/258 | <1 (0–2) | 0/220 | 0 (0–2) | 1/262 | <1 (0–2) |
| Placebo | 0/259 | 0 (0–1) | 0/224 | 0 (0–2) | 0/261 | 0 (0–1) |
The denominator for percentages was the number of participants who received at least one dose in each group for each dose number. Confidence intervals are 95% Blaker confidence intervals.
Severe adverse events are classified as grade 3 or higher.
Severe induration was reported in one participant, on day 2 after MVA-NSmut injection; the severity was reported as mild on days 3 and 4, and the induration resolved on day 5.
Severe headache was reported in one participant, on day 0 after MVA-NSmut injection; the severity was reported as severe on day 1, and the headache resolved on day 2.
Adverse events related to alanine aminotransferase (ALT) levels were analyzed separately among HCV-infected participants and HCV-uninfected participants because increases in ALT levels are characteristic of HCV infection. An increase in ALT level within 30 to 37 days after receipt of vaccine or placebo in the HCV-infected group was attributed to HCV infection. Data in the rows for infected participants correspond to samples collected after a confirmed HCV infection. Data in the rows for uninfected participants correspond to samples collected before any confirmed HCV infection. Participants may be included in both infected and uninfected rows.