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| ID | Type | Description | Link |
|---|---|---|---|
| VAC18193RSV1003 | Other Identifier | Janssen Vaccines & Prevention B.V. |
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The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1 | Experimental | Participants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination). |
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| Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2 | Experimental | Participants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination). |
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| Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3 | Experimental | Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination). |
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| Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4 | Experimental | Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination). |
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| Placebo (Day 1 and Day 365): Group 5 | Experimental | Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.RSV.preF 5*10^10 vp | Biological | Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1) | 7 days after each vaccination (Day 1) | |
| Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365) | 7 days after each vaccination (Day 365) | |
| Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1) | 7 days after each vaccination (Day 1) | |
| Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365) | 7 days after each vaccination (Day 365) | |
| Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination | 28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive) | |
| Number of Participants With Serious Adverse Events (SAEs) Throughout Study | Up to 730 days |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Syncytial Virus (RSV) Neutralization A2 | Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed. | Days 1, 29, 183, 365, 393, 547, 730 |
| RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States |
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| Ad26.RSV.preF 1*10^11 vp | Biological | Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL). |
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| Placebo | Drug | Participants will receive placebo as formulation buffer. |
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Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form. |
| Days 1, 29, 183, 365, 393, 547, 730 |
| Intracellular Cytokine Staining | The activation of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV protein peptide stimulation (including, but not limited to CD4/CD8, interleukin [IL-2], interferon gamma [IFN gamma], tumor necrosis factor alpha [TNF-alpha] and/or activation markers, memory, T-helper [cells] Th1/Th2 subtyping). | Day 1, 29, 183, 365, 393, 547, 730 |