Trials / Terminated
TerminatedNCT05012787
Safety and Immunogenicity of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults With Chronic Immune-Mediated Diseases
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Clover Biopharmaceuticals AUS Pty · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CpG 1018/Alum-adjuvanted SCB-2019 vaccine | Participants will receive 1 intramuscular (IM) injection of 30 microgram (mcg) SCB-2019 with CpG 1018/Alum adjuvant on Day 1 and on Day 22. |
| BIOLOGICAL | Havrix | Participants will receive Havrix (Hepatitis A vaccine) containing 1440 Enzyme-linked Immunosorbent Assay (ELISA) units (EL.U.) in 1.0 mL dose on Day 1. |
| OTHER | Placebo; 0.9% saline | Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 22. |
Timeline
- Start date
- 2021-11-12
- Primary completion
- 2022-03-30
- Completion
- 2022-05-04
- First posted
- 2021-08-19
- Last updated
- 2023-03-24
Locations
4 sites across 1 country: Ukraine
Source: ClinicalTrials.gov record NCT05012787. Inclusion in this directory is not an endorsement.