Stellis Vaccines · VAX-014
Respiratory syncytial virus in older adults
Adjuvanted RSV vaccine Ph2b dose-finding. Enrolment on plan, but a manufacturing lot deviation triggered a 6-week pause to re-qualify; recovery plan in place.
Sit-rep
Status
Enrolling
Health
Watch
Forecast end
Dec 11, 2027
+42d vs plan
Projected EAC
22.8M USD
+1.4M USD vs contract
Live activity
No activity yetKey performance indicators
Threshold colour is supplementary to the on-target / at-risk / breached label.
- Enrolment
- 420 / 600 (70%)
- Screen failure rate
- 14%
- Query aging (>14d)
- 29 open
- Protocol deviations
- 37
- Projected DBL variance
- +42 days
- Budget burn
- 58%
- Forecast EAC
- $22.8M
Timeline & milestones
Bar shows planned span; tick marks current forecast end. Markers are colour-coded by milestone status (labels in tooltip / table below).
| Milestone | Planned | Actual / forecast | Variance | Status |
|---|---|---|---|---|
| FPI | Dec 15, 2024 | Dec 22, 2024 | +7d | Complete |
| 25% enrolment | Apr 30, 2025 | May 8, 2025 | +8d | Complete |
| 50% enrolment | Sep 30, 2025 | Oct 21, 2025 | +21d | Complete |
| 75% enrolment | Feb 28, 2026 | Apr 15, 2026 | +46d | In progress |
| LPI | Aug 30, 2026 | Oct 12, 2026 | +43d | Planned |
| LPLV | Feb 28, 2027 | Apr 11, 2027 | +42d | Planned |
| Database lock | May 30, 2027 | Jul 11, 2027 | +42d | Planned |
| CSR draft | Aug 15, 2027 | Sep 26, 2027 | +42d | Planned |
| CSR final | Oct 30, 2027 | Dec 11, 2027 | +42d | Planned |
| Severity | Title | Owner | Mitigation | Status |
|---|---|---|---|---|
| High | Manufacturing lot deviation on adjuvant lot ADJ-2025-04 | CMC Lead | Lot quarantined; re-qualified replacement lot deployed; CAPA in regulatory review. | Mitigating |
| Medium | Reactogenicity rate slightly above comparator | Medical Monitor | Independent DSMB review at 50% enrolment: continue unchanged. | Closed |
| Low | Seasonal enrolment dip projected through Q3 | CRA Manager | Southern hemisphere sites in start-up to offset. | Mitigating |
| Medium | Central lab assay validation re-run required after method update | Lab Lead | Re-run scheduled; analytical bridge plan agreed. | Open |
Resources
| Role | Headcount | FTE | Monthly rate | Monthly cost |
|---|---|---|---|---|
| CRA | 7 | 5.5 | 19k USD | 103k USD |
| Data Management | 4 | 3.0 | 15k USD | 46k USD |
| Pharmacovigilance | 3 | 1.6 | 18k USD | 29k USD |
| Biostatistics | 2 | 1.5 | 22k USD | 33k USD |
| Medical Writing | 1 | 0.4 | 20k USD | 8k USD |
| CMC / Manufacturing | 2 | 1.0 | 24k USD | 24k USD |
| Total | 19 | 13.0 | — | 243k USD |
Financials
Contracted budget
21.4M USD
EBV spent
12.4M USD
58% of contract
EAC (estimate at completion)
22.8M USD
+1.4M USD vs contract
Burn vs time elapsed
58% / 50%
broadly aligned
Recent activity
Provenance events (24h)
354
Staging items pending
11
Signatures (7d)
27
View provenance for this study →View staged records for this study →
Study goals
Establish dose-response for adjuvanted prefusion-F antigen
Show seroresponse ≥ 4x baseline in ≥ 80% of subjects per dose
Maintain reactogenicity profile comparable to comparator
Generate evidence package supporting Ph3 advancement decision