Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04723602 | Evaluation of Safety, Tolerability and Immune Responses of Ebola-S and Marburg Vaccines in Healthy Adults | PHASE1 | COMPLETED | 32 | — | — | Jan 6, 2021 | Dec 14, 2021 | Aug 3, 2022 | 1 | United States |
Safety of Ebola and Marburg vaccines, as seen in local reactogenicity signs and symptoms with diary questionnaire card.
Safety of Ebola and Marburg vaccines assessed by change in levels of Complete Blood Count (CBC) w/differential count as laboratory measures of safety from baseline.
Safety of Ebola and Marburg vaccines assessed by change in levels of Creatinine as laboratory measures of safety from baseline.
Safety of Ebola and Marburg vaccines assessed by change in levels of Alanine Transaminase (ALT) as laboratory measures of safety from baseline.
Safety of Ebola and Marburg vaccines assessed by adverse events of all severities (Mild, moderate, and severe)
Safety of Ebola and Marburg vaccines assessed by serious adverse events of all severities (Mild, moderate, and severe)
| Arm | Type | Description |
|---|---|---|
| cAd3-Marburg at 1 x 10^11 Particle Units (PU) | ACTIVE_COMPARATOR | A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10\^11 Particle Units (PU) vaccine. |
| cAd3-EBO-S at 1 x 10^11 PU vaccine | ACTIVE_COMPARATOR | A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10\^11 Particle Units (PU) vaccine. |
| Name | Type | Description |
|---|---|---|
| cAd3-Marburg | BIOLOGICAL | A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10\^11 Particle Units (PU) vaccine. |
| cAd3-EBO-S | BIOLOGICAL | A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10\^11 Particle Units (PU) vaccine. |
Inclusion Criteria: * Male or female participant must be between 18-50 (inclusive) years of age; * Meet criteria for plasma donation\*; * Available for clinic follow-up through Day 99 and one additional follow-up call on Day 181 (±14 days); * Agrees not to receive any vaccine from day of enrollment...