NCT06022224

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

A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind Study To Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of a 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	hAd5-S-Fusion+N-ETSD	Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10\^11 viral particles/mL.
BIOLOGICAL	Placebo (0.9% (w/v) saline)	Clear and colorless liquid.

Timeline

• Start date: 2020-12-09
• Primary completion: 2022-06-23
• Completion: 2023-07-19
• First posted: 2023-09-01
• Last updated: 2024-06-07
• Results posted: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study