Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT04950751
Status:
WITHDRAWN
Last Update Posted:
2021-09-10
First Post:
2021-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults
Sponsor:
Clover Biopharmaceuticals AUS Pty
Organization:
Study Overview
Official Title:
An Observer-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decided to withdrawn the study as development strategy has changed
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 2, randomized, controlled, observer-blind study to evaluate the immunogenicity and safety of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from B.1.351 variant) subunit vaccine (SCB-2020S), when administered as 2-dose vaccination series 21 days apart to adults ≥ 18 years of age.
Detailed Description:
Clover has developed a second candidate vaccine, SCB-2020S, that contains S protein from the dominant B.1.351 variant. The purpose of clinical study CLO-SCB-2020-001 is to assess the immunogenicity and safety of different formulations of the SCB-2020S compared to the prototype SCB-2019 vaccine, and to select a formulation of SCB-2020S for further clinical development. The protocol plans to enroll 150 participants. There will be 5 study arms and participants will receive two intramuscular (i.m.) injections, one at Day 1 and one at Day 22.
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?: