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Safety and Immunogenicity of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults With Chronic Immune-Mediated Diseases — COVID-19  

COVID-19 Clinical Trial

Official title:
A Double-Blind, Randomized, Controlled, Phase 3 Study to Evaluate the Safety and Immunogenicity of CpG 1018/Alum-adjuvanted SCB-2019 in Individuals Aged 18 and Above With Chronic Immune-Mediated Inflammatory Diseases

Clinical Trial Summary

The purpose of the study is to evaluate the safety and immunogenicity of the investigational CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 trimeric spike (S)-protein subunit vaccine (SCB-2019) in adult participants with stable chronic inflammatory immune-mediated diseases (IMDs), compared to control vaccine.

Clinical Trial Description

This study is to evaluate the safety and immunogenicity of the investigational CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB 2019) compared with control. Approximately 300 study participants with rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and relapsing-remitting multiple sclerosis (RRMS) will be randomized according a 1:1 ratio to receive SCB-2019 or control vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05012787
Study type Interventional
Source Clover Biopharmaceuticals AUS Pty Ltd
Contact
Status Terminated
Phase Phase 3
Start date November 12, 2021
Completion date May 4, 2022
View Details
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