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A total of 63 subjects will be recruited into three groups (18 subjects per group will receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen suspension of MVA BN RSV.
Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per 0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo |
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| Group 2 | Experimental | 18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo |
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| Group 3 | Experimental | 50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA BN RSV | Biological | Liquid frozen suspension of 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 |
| Occurrence of grade 3 adverse events | Occurrence of any grade 3 or higher adverse events possibly, probably or definitely related to the trial vaccine within four weeks after each vaccination. | Screening up to week 8 after first vaccination |
| Solicited local adverse events | Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination | day of vaccination and the following seven days |
| Unsolicited non-serious adverse events | Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events | within four weeks after each vaccination |
| Solicited general adverse events | Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events | day of vaccination and the following seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccinia-specific cellular immune responses. | To assess the RSV-specific and vaccinia-specific cellular immune responses against the MVA-BN RSV vaccine in healthy adult subjects. Spot forming units will be determined by using an IFN-γ ELISPOT assay. | cellular immune response measured up to week 4 after 2nd vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casey Johnson, DO | Johnson County Clin-Trials (JCCT) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clin-Trials (JCCT) | Lenexa | Kansas | 66219 | United States |
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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, sterile |
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| RSV-specific humoral immune response |
To assess the RSV-specific serum antibody responses by ELISA |
| humoral immune response is measured up to week 34 |
| RSV-specific humoral immune response | To assess the RSV-specific serum antibody responses by PRNT | humoral immune response is measured up to week 34 |
| RSV-specific humoral immune response | To assess the RSV-specific mucosal antibody responses by ELISA | humoral immune response is measured up to week 34 |
| Vaccinica-specific humoral immune response | To assess the Vaccinica-specific serum antibody responses by ELISA | humoral immune response is measured up to week 34 |
| D014777 | Virus Diseases |
| D007239 | Infections |