Table 4.
Summary of Ad26 RSV vaccine clinical studies.
| Study | Sponsor (IND holder) | Vaccine | Status | Phase/Blind/Allocation/ Participants/Country | Protocol-specified vaccination groups | Planned number of participants | Reference NCT No. |
|---|---|---|---|---|---|---|---|
|
VAC18192 RSV1001 |
Janssen | Ad35.RSV.FA2 Ad26.RSV.FA2 |
Completed | Phase 1/Double-blind (observer-blind)/Randomized/Healthy adults/US | 1 × 1011 vp Ad35.RSV.FA2 (Days 1, 85), 5 × 1010 vp Ad26.RSV.FA2 (Day 169) |
12 | NCT02440035 |
| 1 × 1011 vp Ad35.RSV.FA2 (Days 1, 169), placebo (Day 85) |
12 | ||||||
| 1 × 1011 vp Ad35.RSV.FA2 (Day 1), placebo (Day 85), 5 × 1010 vp Ad26.RSV.FA2 (Day 169) |
12 | ||||||
| Placebo (Days 1, 85), 5 × 1010 vp Ad26.RSV.FA2 (Day 169) |
12 | ||||||
|
VAC18192 RSV1003 |
Janssen | Ad35.RSV.FA2 Ad26.RSV.FA2 |
Completed | Phase 1/Double-blind (observer-blind)/Randomized/Healthy adults/US | 5 × 1010 vp Ad26.RSV.FA2 (Days 1, 85), 1 × 1011 vp Ad35.RSV.FA2 (Day 169) |
12 | NCT02561871 |
| 5 × 1010 vp Ad26.RSV.FA2 (Day 1), 1 × 1011 vp Ad35.RSV.FA2 (Day 85), placebo (Day 169) |
12 | ||||||
| Placebo | 8 | ||||||
|
VAC18193 RSV2002 |
Janssen | Ad26.RSV.preF | Ongoing | Phase 2a/Double-blind (observer-blind)/Randomized/Healthy adults/UK | 1 × 1011 vp Ad26.RSV.preF (Day −28) Challenged intranasally with RSV-A at Day 0 |
22 | NCT03334695 |
| Placebo (Day −28) Challenged intranasally with RSV-A at Day 0 |
22 | ||||||
|
VAC18193 RSV2003 |
Janssen | Ad26.RSV.preF | Completed | Phase 2a/Double-blind (observer-blind)/Randomized/Healthy older adults (≥60 years of age)/US | 1 × 1011 vp Ad26.RSV.preF (Day 1), Fluarix® Quadrivalent (Day 1), placebo (Day 29) |
90 | NCT03339713 |
| Fluarix® Quadrivalent (Day 1), placebo (Day 1), 1 × 1011 vp Ad26.RSV.preF (Day 29) |
90 | ||||||
Cut-off for studies 21 December 2018.
Ad26, adenovirus serotype 26; Ad35, adenovirus serotype 35; FA2, F protein of RSV strain A2; preF, prefusion F protein; RSV, respiratory syncytial virus; vp, viral particles.