Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-29 @ 2:09 AM
Study NCT ID:
NCT04732468
Status:
TERMINATED
Last Update Posted:
2024-10-15
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
Sponsor:
ImmunityBio, Inc.
Organization:
Study Overview
Official Title:
Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early due to low enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) and to select an optimal combination dose for future studies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: