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Protocol was withdrawn from IND
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A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | ≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application |
|
| Group 2 | Experimental | ≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application |
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| Group 3 | Experimental | ≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application |
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| Group 4 | Experimental | ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application |
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| Group 5 | Experimental | ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA-BN-RSV | Biological | MVA-mBN294B |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of serious adverse events | Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE). | Screening up to week 34 after first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| RSV-specific humoral immune response | To assess the RSV-specific serum antibody responses | humoral immune response is measured up to week 34 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Fierro, MD | Johnson County Clin-Trials (JCCT) | Principal Investigator |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Other | Tris Buffered Saline |
|
| D014777 | Virus Diseases |
| D007239 | Infections |