Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
cAd3-Marburg · 1 trial · 2 indications
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...
cAd3-Marburg is an investigational vaccine being studied for the prevention of Marburg virus disease, a severe and often fatal illness. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
cAd3-Marburg is being developed by Icon Plc, a company traded on the NASDAQ under the ticker symbol ICLR. The vaccine is in Phase 1 clinical trials and remains investigational.
cAd3-Marburg is in Phase 1 clinical development. It is an investigational vaccine and has not received regulatory approval. A Phase 1 trial evaluating its safety and immune responses has been completed.
cAd3-Marburg was evaluated in a completed Phase 1 trial with the identifier NCT04723602. This study assessed the safety, tolerability, and immune responses of the vaccine in 32 healthy adults in the United States.
cAd3-Marburg is a distinct vaccine candidate targeting Marburg virus disease. It was studied alongside an Ebola-S vaccine in the same clinical trial, but they are separate investigational vaccines with different targets.