Table 5.
Rates of unsolicited adverse events after each dose and serious adverse events over the whole study duration in the respective groups of the two studies, n (%).
| Study 1: Group 1 [Leiden WVS] | Study 1: Group 2 [Bern WVS] | Study 1: Group 3 [Leiden MVSa] | Study 1: Group 4 [Placebo] | Study 2: Group 1 [Full clinical dose] | Study 2: Group 2 [Intermediate dose] | Study 2: Group 3 [Low dose] | Study 2: Group 4 [Placebo] | |
|---|---|---|---|---|---|---|---|---|
| Post-dose 1 (Ad26.ZEBOV or placebo), N = | 94 | 94 | 94 | 47 | 150 | 150 | 150 | 75 |
| Any unsolicited AE, n (%) | 7 (7.4) | 13 (13.8) | 16 (17.0) | 10 (21.3) | 10 (6.7) | 12 (8.0) | 10 (6.7) | 11 (14.7) |
| Severity grade 3 | 0 | 0 | 0 | 1 (2.1) | 0 | 2 (1.3) | 0 | 0 |
| Post-dose 2 (MVA-BN-Filo or placebo), N = | 88 | 91 | 91 | 45 | 145 | 143 | 144 | 72 |
| Any unsolicited AE, n (%) | 7 (8.0) | 13 (14.3) | 16 (17.6) | 4 (8.9) | 8 (5.5) | 8 (5.6) | 8 (5.6) | 3 (4.2) |
| Severity grade 3 | 0 | 0 | 1 (1.1) | 0 | 1 (0.7) | 0 | 0 | 0 |
| Whole study duration, N = | 94 | 94 | 94 | 47 | 150 | 150 | 150 | 75 |
| SAE, n (%) | 1 (1.1) | 2 (2.1)b | 1 (1.1) | 3 (6.4)b | 1 (0.7) | 2 (1.3)c | 1 (0.7) | 0 |
| Related | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
aSame Leiden MVS batch as used in phase 1/2 studies.
bIncludes one death due to drug overdose.
cIncludes two deaths (gunshot wound and narcotic drug toxicity).
Unsolicited AEs were based on investigator assessment and were reported from signing of the informed consent form until 42 days post-dose 2; SAEs were reported from signing of the informed consent form until the end of the study (day 237).
AE: adverse event; MVS: master virus seed; N: number of participants with data at that time point; n (%): number (percentage) of participants with one or more events, where the denominator is the number of participants with available reactogenicity data after the given dose; SAE: serious adverse event; WVS: working virus seed.