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
Brief 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.

Terminated
COVID-19

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 Name: Hepatitis A vaccine

Other: Placebo; 0.9% saline

Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 22.

Eligibility Criteria

Inclusion Criteria:

1. Male or female greater than or equal to (>=) 18 years of age.

2. Participants who are willing and able to comply with study requirements, including all
scheduled visits, vaccinations, laboratory tests, and other study procedures.

3. Participants are willing and able to give an informed consent, prior to screening.

4. Participants should be in generally good health except for the following chronic
immune-mediated diseases:

- RA who received chronic ([>=] 3 months) immunosuppressive therapy with
immunomodulators (such as methotrexate and abatacept), TNF-alpha inhibitors (such
as etanercept, adalimumab, certolizumab, golimumab or infliximab), janus kinase
(JAK) Inhibitors (such as tofacitinib or baricitinib), or Interleukin-6 (IL-6)
receptor inhibitors (such as tocilizumab).

- IBD: (Crohn's disease, Ulcerative colitis or Indeterminate colitis) who received
chronic ([>=] 3 months) immunosuppressive therapy with TNF-alpha inhibitors (such
as infliximab or adalimumab), immunomodulators (such as 6- mercaptopurine,
azathioprine, or methotrexate), corticosteroids (such as prednisone,
prednisolone, or methylprednisolone), or tacrolimus.

- RRMS who received chronic ([>=] 6 months) stable disease modifying therapy (DMT)
with platform therapeutics (beta-interferons, glatirameracetate, teriflunomide,
dimethylfumarate), Sphingosine-1-phosphate receptor (S1PR) modulators
(fingolimod, ozanimod, siponimod) or monoclonals (natalizumab).

5. Participants should be in remission (RA, IBD), or have low disease activity (RA) or
stable disease (RRMS) without modification of immunosuppressive therapy (i.e. no dose
change, no medication change, no rescue therapy) for at least 3 months (6 months for
RRMS) prior to enrollment and not anticipated to undergo a change in immunosuppressive
therapy for 1 month after Dose 2.

6. Female participant are eligible to participate in the study if not pregnant and
breastfeeding.

7. Male participants must agree to employ acceptable contraception from the day of first
dose of the study vaccine and during the entire study period and also refrain from
donating sperm during this period.

Exclusion Criteria:

1. Participants with fever > 37.5°C (irrespective of method), or any acute illness at
baseline (Day 1) or within 3 days prior to randomization. Participants meeting this
criterion may be rescheduled (within the relevant window). Febrile participants with
minor illnesses can be enrolled at the discretion of the investigator.

2. Participants with confirmed SARS-CoV-2 infection (as defined by Rapid COVID Antigen
Test or an equivalent at Visit 1) or with history of COVID-19.

3. Participants who have received a prior investigational or licensed COVID-19 vaccine,
or previous hepatitis A vaccine 12 months prior to Day 1.

4. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
from disease (e.g., malignancy, HIV infection) or having received systemic
corticosteroids and/or immunosuppressive/cytotoxic therapy (e.g., medications used for
cancer chemotherapy, organ transplantation or to treat autoimmune disorders other than
RA, IBD or RRMS) within 6 months prior to enrollment.

5. Participants with any progressive unstable or uncontrolled clinical conditions.

6. Participants with surgery scheduled during the study period.

7. Participants who have a history of severe adverse reaction associated with a vaccine
or severe allergic reaction (e.g., anaphylaxis) to any component of the study
vaccines, such as hepatitis A vaccine (as outlined in the Havrix Summary of Product
Characteristics, EU SmPC, GSK, 2020), or CpG 1018/Alum/SCB-2019 components as outlined
in the latest IB.

8. Participants who have a history of malignancy within 1 year before screening
(exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ
of the cervix which have been cured, or other malignancies with minimal risk of
recurrence).

9. Participants who have received any other investigational product within 3 months to
Day 1 or intent to participate in another clinical study at any time during the
conduct of this study.

10. Participants who have received any other licensed vaccines within 14 days prior to
enrollment in this study or who are planning to receive any vaccine up to 14 days
after the second vaccination.

11. Participants with known bleeding disorder that would, in the opinion of the
investigator, contraindicate intramuscular injection.

12. Participants who have received treatment with Rituximab or any other anti-CD20
monoclonal antibodies within 9 months prior to enrollment or planned during the study
period.

13. Administration of intravenous immunoglobulins and/or any blood products within 3
months prior to enrollment or planned administration during the study period.

14. Participants with any condition that, in the opinion of the investigator, would
interfere with the primary study objectives or pose additional participant risk.

15. Participants with any seizure disorder, or history of Guillian-Barré syndrome.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Ukraine
Locations

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

Clover Biopharmaceuticals AUS Pty Ltd
NCT Number
MeSH Terms
Vaccines
1018 oligonucleotide