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Also known as JNJ-64400141
Ad26.RSV.preF 5*10^10 vp · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| 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). |
| 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 |
|---|---|---|
| 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). |
| 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). |
| Placebo | DRUG | Participants will receive placebo as formulation buffer. |
Inclusion Criteria: * Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study proced...
Ad26.RSV.preF 5*10^10 vp is an investigational vaccine candidate developed by Johnson & Johnson for respiratory syncytial virus (RSV). The designation 5*10^10 vp refers to the dose strength of viral particles used in clinical testing. It is not yet approved and remains in clinical development.
Ad26.RSV.preF 5*10^10 vp is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is responsible for the clinical program evaluating this vaccine candidate.
Ad26.RSV.preF 5*10^10 vp is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The candidate has not been approved by the FDA or any regulatory agency.
Ad26.RSV.preF 5*10^10 vp has been evaluated in a single completed Phase 1 trial, NCT02926430. The study assessed the safety, tolerability, and immunogenicity of two vaccinations given one year apart in adults aged 60 years and older in stable health. It enrolled 73 participants in the United States.
NCT02926430 was a randomized, double-blind, controlled Phase 1 trial of Ad26.RSV.preF 5*10^10 vp. It enrolled 73 healthy adults aged 60 years and older in the United States. Participants received two vaccinations one year apart, and the study evaluated safety, tolerability, and immunogenicity. The trial is completed.