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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1
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.
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.
Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 22.
Medical Centre of Edelweiss Medics LLC
Kyiv, Ukraine
Medical Center of Medbud-Clinic LLC
Kyiv, Ukraine
Center of Family Medicine Plus, LLC
Kyiv, Ukraine
Medical Center Salutem LLC
Vinnitsa, Ukraine
Percentage of Participants With Unsolicited Adverse Events (AEs)
Time frame: Day 1 through Day 43
Percentage of Participants With Medically Attended AEs (MAAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time frame: Day 1 through Day 205
Percentage of Participants With Any Confirmed Relapse of Immune-mediated Disease (RA, IBD, or RRMS)
Time frame: Day 1 through Day 205
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb)
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SARS-CoV-2 nAb
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SCB-2019 Binding Antibody
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants With RA, IBD, and RRMS
Time frame: Day 1, 22, 36 and 205
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Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants With RA, IBD, and RRMS
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants With RA, IBD and RRMS
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Corticosteroids
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Corticosteroids
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Corticosteroids
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Tumor Necrosis Factor (TNF)-alpha Inhibitors
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive TNF-alpha Inhibitors
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Received TNF-alpha Inhibitors
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Immunomodulators
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Immunomodulators
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Receive Immunomodulators
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Other Treatment Regimens
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens
Time frame: Day 22, 36 and 205
Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens
Time frame: Day 1, 22, 36 and 205
Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens
Time frame: Day 22, 36 and 205
Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens
Time frame: Day 22, 36 and 205
Number of Participants With Local and Systemic Solicited AEs
Time frame: Day 1 to 7 and Day 22 to 29