drugset / Trial / NCT06022224

A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL

NCT06022224 ↗

Phase 2/3 Terminated 35 enrolled ImmunityBio, Inc.
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

EvaluationDrugModalityDoseRoute
Subject hAd5-S-Fusion+N-ETSD Vaccine 1e+11 unknown Subcutaneous

Indications