Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-28 @ 12:12 PM
Study NCT ID:
NCT05602961
Status:
WITHDRAWN
Last Update Posted:
2023-08-14
First Post:
2022-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Study of GLB-COV2-043 as a COVID-19 Vaccine Booster
Sponsor:
GreenLight Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Phase I/II Partially Randomized, Active-controlled Observer-blind, Dose-selection, Safety and Immunogenicity Study of GLB-COV2-043, an mRNA Vaccine Candidate Against SARS-CoV-2, Administered as a Single-vaccination Booster to Previously Vaccinated Adults
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
to prioritize other programs.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The scope of this Phase I/II study is to determine whether GLB-COV2-043 is a promising booster vaccine candidate component for adult participants who have received the 2-dose priming course of the mRNA BNT162b2 vaccine against COVID-19, or the 2-dose priming course and a third BNT162b2 injection (i.e., as a "booster"), and, if so, to select the booster dose for further evaluation and potential development.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: