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COVID-19Phase 3COVID-19NCT05012787

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

A Phase 3 study testing CpG 1018/Alum-adjuvanted SCB-2019 vaccine and Havrix in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 4 sites in Ukraine.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
CpG 1018/Alum-adjuvanted SCB-2019 vaccine and Havrix
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1 participants
Where
4 sitesUkraine
Study dates
12 Nov 2021to 4 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female greater than or equal to (>=) 18 years of age.
  • Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
  • Participants are willing and able to give an informed consent, prior to screening.
  • 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.
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  • 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).
  • 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.
  • Female participant are eligible to participate in the study if not pregnant and breastfeeding.
  • 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.

Who cannot join

  • 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.
  • 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.
  • Participants who have received a prior investigational or licensed COVID-19 vaccine, or previous hepatitis A vaccine 12 months prior to Day 1.
  • 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.
  • Participants with any progressive unstable or uncontrolled clinical conditions.
  • Participants with surgery scheduled during the study period.
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  • 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.
  • 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).
  • 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.
  • 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.
  • Participants with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • 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.
  • Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period.
  • Participants with any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional participant risk.
  • Participants with any seizure disorder, or history of Guillian-Barré syndrome.

Trial locations and contacts

4 sites in 1 country.

Ukraine4 sites

  • Medical Centre of Edelweiss Medics LLC

    Kyiv, 2002

  • Medical Center of Medbud-Clinic LLC

    Kyiv, 3037

  • Center of Family Medicine Plus, LLC

    Kyiv, 4210

  • Medical Center Salutem LLC

    Vinnitsa, 21009

Other trials in Ukraine

About this study

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

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.

Read the 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
COVID-19
Being tested
CpG 1018/Alum-adjuvanted SCB-2019 vaccine, Havrix, Placebo; 0.9% saline
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CpG 1018/Alum-adjuvanted SCB-2019 vaccineBiological

    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.

  • HavrixBiological

    Also called Hepatitis A vaccine

    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.

  • Placebo; 0.9% salineOther

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

Study groups in NCT05012787
Study groupRoleWhat they receive
SCB-2019 GroupExperimentalCpG 1018/Alum-adjuvanted SCB-2019 vaccine
Receives: Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine
Control GroupPlacebo comparatorHavrix and Placebo
Receives: Biological: Havrix; Other: Placebo; 0.9% saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Unsolicited Adverse Events (AEs)

    Measured: Day 1 through Day 43

  2. Percentage of Participants With Medically Attended AEs (MAAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

    Measured: Day 1 through Day 205

  3. Percentage of Participants With Any Confirmed Relapse of Immune-mediated Disease (RA, IBD, or RRMS)

    Measured: Day 1 through Day 205

Secondary outcomes (37)

  1. Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb)

    Measured: Day 1, 22, 36 and 205

  2. Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb

    Measured: Day 22, 36 and 205

  3. Number of Participants With Seroconversion for SARS-CoV-2 nAb

    Measured: Day 22, 36 and 205

  4. Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody

    Measured: Day 1, 22, 36 and 205

  5. Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody

    Measured: Day 22, 36 and 205

  6. Number of Participants With Seroconversion for SCB-2019 Binding Antibody

    Measured: Day 22, 36 and 205

  7. Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants With RA, IBD, and RRMS

    Measured: Day 1, 22, 36 and 205

  8. Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants With RA, IBD, and RRMS

    Measured: Day 22, 36 and 205

  9. Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants With RA, IBD and RRMS

    Measured: Day 22, 36 and 205

  10. Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS

    Measured: Day 1, 22, 36 and 205

  11. Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS

    Measured: Day 22, 36 and 205

  12. Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants With RA, IBD, and RRMS

    Measured: Day 22, 36 and 205

  13. Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Corticosteroids

    Measured: Day 1, 22, 36 and 205

  14. Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Corticosteroids

    Measured: Day 22, 36 and 205

  15. Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Corticosteroids

    Measured: Day 22, 36 and 205

  16. Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids

    Measured: Day 1, 22, 36 and 205

  17. Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids

    Measured: Day 22, 36 and 205

  18. Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Corticosteroids

    Measured: Day 22, 36 and 205

  19. Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Tumor Necrosis Factor (TNF)-alpha Inhibitors

    Measured: Day 1, 22, 36 and 205

  20. Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive TNF-alpha Inhibitors

    Measured: Day 22, 36 and 205

  21. Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Received TNF-alpha Inhibitors

    Measured: Day 22, 36 and 205

  22. Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors

    Measured: Day 1, 22, 36 and 205

  23. Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors

    Measured: Day 22, 36 and 205

  24. Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive TNF-alpha Inhibitors

    Measured: Day 22, 36 and 205

  25. Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Immunomodulators

    Measured: Day 1, 22, 36 and 205

  26. Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Immunomodulators

    Measured: Day 22, 36 and 205

  27. Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants who Receive Immunomodulators

    Measured: Day 22, 36 and 205

  28. Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators

    Measured: Day 1, 22, 36 and 205

  29. Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators

    Measured: Day 22, 36 and 205

  30. Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Immunomodulators

    Measured: Day 22, 36 and 205

  31. Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Antibody (nAb) in Participants Who Receive Other Treatment Regimens

    Measured: Day 1, 22, 36 and 205

  32. Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens

    Measured: Day 22, 36 and 205

  33. Number of Participants With Seroconversion for SARS-CoV-2 nAb in Participants Who Receive Other Treatment Regimens

    Measured: Day 22, 36 and 205

  34. Geometric Mean Titer (GMT) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens

    Measured: Day 1, 22, 36 and 205

  35. Geometric Mean Fold Rise (GMFRs) of SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens

    Measured: Day 22, 36 and 205

  36. Number of Participants With Seroconversion for SCB-2019 Binding Antibody in Participants Who Receive Other Treatment Regimens

    Measured: Day 22, 36 and 205

  37. Number of Participants With Local and Systemic Solicited AEs

    Measured: Day 1 to 7 and Day 22 to 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start12 Nov 2021
  3. Primary completion30 Mar 2022
  4. Study completion4 May 2022

Why it stopped: The study was early terminated considering the inability to enroll the required study population.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05012787
Sponsor's protocol ID
CLO-SCB-2019-005
Acronym
COVID-19
Status last verified
Mar 2023
First submitted
18 Aug 2021
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CpG 1018/Alum-adjuvanted SCB-2019 vaccine and Havrix in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 4 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was early terminated considering the inability to enroll the required study population.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Unsolicited Adverse Events (AEs) (time frame: Day 1 through Day 43). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05012787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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