AzTrials
AzTrials

COVID-19Phase 3NCT05926440

Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults

A Phase 3 study testing SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection and SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 3 sites in Philippines.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection and SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesPhilippines
Study dates
17 Aug 2023to 17 Aug 2023
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 years of age.
  • Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
  • Individuals willing and able to give an informed consent, prior to screening.
  • Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
  • Individuals who received three doses of inactivated COVID-19 vaccine.

Who cannot join

  • Body temperature >37.8°C (axillary), or any acute illness at baseline.
  • Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
  • Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
  • Any progressive unstable or uncontrolled clinical conditions.
  • Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
Show all 14Show fewer
  • History of severe adverse reaction associated with a vaccine or severe allergic reaction.
  • History of malignancy within 1 year before screening.
  • Individuals who have received any other investigational product.
  • Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
  • Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
  • Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
  • Administration of intravenous immunoglobulins and/or any blood products.
  • Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.

Trial locations and contacts

3 sites in 1 country.

Philippines3 sites

  • Health Index Multispecialty Clinic

    Manila

  • Manila Doctors Hospital

    Manila

  • Tropical Disease Foundation

    Putatan

Other trials in Philippines

About this study

Official title: Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of SCB-2023 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine

The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.

Conditions
COVID-19
Being tested
SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection, SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
Medical subject headings
COVID-19

What participants receive

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

  • SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injectionBiological

    SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

  • SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injectionBiological

    SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

Study groups in NCT05926440
Study groupRoleWhat they receive
SCB-2023 armExperimentalParticipants will receive one booster dose with SCB-2023 vaccine on Day 1
Receives: Biological: SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
SCB-2019 armActive comparatorParticipants will receive one booster dose with SCB-2019 vaccine on Day 1
Receives: Biological: SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection

What is being measured

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

  1. To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5

    GMT ratio

    Measured: Day 15

  2. To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5

    GMT ratio

    Measured: Day 15

  3. Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine

    Proportion of participants with local and systemic AEs

    Measured: Day 7

  4. Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine

    Proportion of participants with unsolicited AEs

    Measured: Day 29

  5. Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine

    Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs

    Measured: Up to 1 year post-vaccination

Secondary outcomes (9)

  1. Non-inferiority with respect to ratio of the geometric mean of Omicron BA.5 titer in SCB-2023 recipients and SARS-CoV-2 Delta titers in SCB-2019 recipients, as measured by virus neutralization assay.

    GMT ratio

    Measured: Day 15

  2. Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5.

    GMTs; GMFRs; SCRs; Proportion of participants with antibody titer ≥ LLoQ

    Measured: Day 1, 15, 180

  3. Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5

    GMFRs

    Measured: Day 1, 15, 180

  4. Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5

    SCRs

    Measured: Day 1, 15, 180

  5. Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5

    Proportion of participants with antibody titer ≥ LLoQ

    Measured: Day 1, 15, 180

  6. Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern

    GMTs

    Measured: Day 1, 15

  7. Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern

    GMFRs

    Measured: Day 1, 15

  8. Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern

    SCRs

    Measured: Day 1, 15

  9. Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern

    Proportion of participants with antibody titer ≥ LLoQ

    Measured: Day 1, 15

Timeline

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

  1. First posted3 Jul 2023
  2. Study start17 Aug 2023
  3. Primary completion17 Aug 2023
  4. Study completion17 Aug 2023

Why it stopped: we has selected a new candidate vaccine which is monovalent.

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05926440
Sponsor's protocol ID
CLO-SCB-2023-002
Status last verified
Aug 2023
First submitted
8 Jun 2023
Last updated
25 Aug 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 SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection and SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 3 sites in Philippines.

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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Philippines. 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. 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 withdrawn before enrolling participants, so there are no results.

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?

To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5 (time frame: Day 15). The study lists 5 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 NCT05926440.

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 25 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in