drugset / Trial / NCT06022224
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
RandomizedSequentialTriple-blindTreatment
Summary
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will be in the \>55-year stratum. Safety, immunogenicity, and efficacy assessments will be conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to a maximum of approximately 2 years.
Timeline
- Start
- 2020-12-09
- Primary completion
- 2022-06-23
- Completion
- 2023-07-19
Outcome
Outcome not reported
Stopped (Enrollment): “There were no participants enrolled into Phase 3 portion of the study because the study was prematurely terminated.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | hAd5-S-Fusion+N-ETSD | Vaccine | 1e+11 unknown | Subcutaneous |