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Ad26.ZEBOV 5*10^10 viral particles · 1 trial · 1 indication
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Ad26.ZEBOV 5\*10\^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 1\*10\^8 Infectious Unit \[Inf. U.\] single dose IM injection on Day 57 |
| Group 2 | EXPERIMENTAL | Ad26.ZEBOV 2\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U single dose IM injection on Day 57 |
| Group 3 | EXPERIMENTAL | Ad26.ZEBOV 0.8\*10\^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 5\*10\^7 Inf. U. single dose IM injection on Day 57 |
| Group 4 | EXPERIMENTAL | Participants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57 |
| Name | Type | Description |
|---|---|---|
| Ad26.ZEBOV 5*10^10 viral particles (vp) | BIOLOGICAL | Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1 |
| Ad26.ZEBOV 2*10^10 (vp) | BIOLOGICAL | Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2\*10\^10 viral particles on Day 1 |
| Ad26.ZEBOV 0.8*10^10 (vp) | BIOLOGICAL | Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8\*10\^10 viral particles on Day 1 |
| MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.] | BIOLOGICAL | MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57 |
| MVA-BN-Filo 5*10^7 Inf. U. | BIOLOGICAL | MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5\*10\^7 Inf. U. once on Day 57 |
| Placebo | BIOLOGICAL | One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57 |
Inclusion criteria : * Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening * Must be healthy on the basis of clinical laboratory tests performed at Screening * Before randomizat...
Ad26.ZEBOV 5*10^10 viral particles is an investigational vaccine being studied in healthy adults. It is being evaluated in a Phase 3 clinical trial to assess the safety and immunogenicity of different dose levels of Ad26.ZEBOV when given with MVA-BN-Filo. The study is completed and enrolled 525 participants in the United States.
Ad26.ZEBOV 5*10^10 viral particles is being developed by Johnson & Johnson (NYSE: JNJ). The company sponsored a Phase 3 clinical trial of the vaccine candidate in healthy adult participants.
Ad26.ZEBOV 5*10^10 viral particles is in Phase 3 clinical development. The Phase 3 trial, which has been completed, evaluated a range of dose levels of Ad26.ZEBOV and MVA-BN-Filo in healthy adults. The vaccine is investigational and has not been approved by regulatory authorities.
Ad26.ZEBOV 5*10^10 viral particles was studied in the completed Phase 3 trial NCT02543567, titled 'A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants.' The randomized, double-blind, controlled trial enrolled 525 healthy adults aged 18 years and older in the United States.
No, Ad26.ZEBOV 5*10^10 viral particles is not the same as MVA-BN-Filo. In the Phase 3 trial NCT02543567, Ad26.ZEBOV was evaluated in combination with MVA-BN-Filo, which is a separate vaccine component. The study assessed different dose levels of Ad26.ZEBOV when administered alongside MVA-BN-Filo.