COVID-19Phase 2NCT04950751

Immunogenicity and Safety of Adjuvanted SCB-2020S Vaccines in Adults

A Phase 2 study testing candidate vaccine, SCB-2020S in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This is a phase 2, randomized, controlled, observer-blind study to evaluate the immunogenicity and safety of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from B.1.351 variant) subunit vaccine (SCB-2020S), when administered as 2-dose vaccination series 21 days… 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?: candidate vaccine, SCB-2020S
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Aug 2021to Apr 2022
Phase: Phase 2
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

1. Male or female ≥18 years of age
2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
3.Individuals are willing and able to give an informed consent, prior to screening
4. Healthy participants or participants with pre-existing medical conditions* who are in a stable medical condition. (*A stable medical condition is defined as disease not requiring significant change or hospitalization for worsening disease during the 3 months before enrollment.)
5. Female participants of childbearing potential may be enrolled in the study, if the participant has practiced adequate contraception for 30 days prior to vaccination and has a negative pregnancy test on the day of vaccination and has agreed to continue adequate contraception for 3 months after the last vaccination
6. Male participants must agree to employ acceptable contraception from the day of the first dose of the study vaccine until 6 months after the last dose of the study vaccine and also refrain from donating sperm during this period.

Who cannot join

1. Individuals with body temperature >37.5°C (axillary), 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. Individuals with laboratory-confirmed SARS-CoV-2 infection [as defined by reverse transcriptase polymerase chain reaction (RT-PCR) assay or Rapid COVID Antigen Test or an equivalent at Visit 1] or with history of COVID-19.
3. Individuals seropositive at Baseline for SARS-CoV-2.
4.Individuals who have received an investigational or authorized COVID-19 vaccine prior to Day 1, or plan to receive COVID-19 vaccine during the study period.
5. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease [e.g., malignancy, human immunodeficiency virus (HIV) infection] or immunosuppressive/cytotoxic therapy (e.g., systemic corticosteroids, medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 3 months prior to Day 1.
6. Individuals with any progressive unstable or uncontrolled clinical conditions.

Show all 19Show fewer

7. Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
8. Individuals 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 (CpG 1018, aluminum), or SCB-2020S/SCB-2019 components ].
9. Individuals 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).
10. Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
11. Individuals 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 21 days after the second vaccination.
12. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
13. Individuals who have received treatment with Rituximab or any other anti-CD20 monoclonal antibodies within 9 months prior to Day 1 or planned during the study period.
14. Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period.
15. Individuals with positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at Screening.
16. Individuals with safety laboratory test results (hematology, chemistry, and coagulation) with a toxicity score of Grade ≥2 at Screening (see Laboratory Manual for laboratory-specific normal ranges and associated toxicity grades). The inclusion of subjects with non-clinically significant (NCS) Grade 1 laboratory abnormalities is allowed based on the Investigator's discretion.
17. The subject has a reported or documented history of alcohol abuse or drug addiction or nonmedicinal recreational drug use (excluding nonprescription health supplements and herbal remedies) within 1 year before the planned day of dose administration.
18. The subject has a positive test result for drugs of abuse at Screening.
19. Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.

About this study

Official title: An Observer-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults

Read the detailed description

Clover has developed a second candidate vaccine, SCB-2020S, that contains S protein from the dominant B.1.351 variant. The purpose of clinical study CLO-SCB-2020-001 is to assess the immunogenicity and safety of different formulations of the SCB-2020S compared to the prototype SCB-2019 vaccine, and to select a formulation of SCB-2020S for further clinical development. The protocol plans to enroll 150 participants. There will be 5 study arms and participants will receive two intramuscular (i.m.) injections, one at Day 1 and one at Day 22.

Conditions: COVID-19
Being tested: candidate vaccine, SCB-2020S
Medical subject headings: COVID-19

What participants receive

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

candidate vaccine, SCB-2020SBiological
a recombinant SARS-Co-2 trimeric S-protein (from B.1.351 variant) subunit vaccine for COVID-19

Study groups in NCT04950751
Study group	Role	What they receive
SCB-2020S Standard Dose	Experimental	Day 1 and 22: standard dose SCB-2020S with CpG 1018/alum adjuvant Receives: Biological: candidate vaccine, SCB-2020S
SCB-2020S Low Antigen Dose	Experimental	Day 1 and 22: low dose SCB-2020S with CpG 1018/alum adjuvant Receives: Biological: candidate vaccine, SCB-2020S
SCB-2020S Low Adjuvant Dose	Experimental	Day 1 and 22: standard dose SCB-2020S with low dose CpG 1018/alum adjuvant Receives: Biological: candidate vaccine, SCB-2020S
SCB-2020S Mixed Series	Experimental	Day 1 (Dose 1) standard dose SCB-2020S with CpG 1018/alum adjuvant and Day 22 Dose 2) standard dose SCB-2020S with alum adjuvant Receives: Biological: candidate vaccine, SCB-2020S
SCB-2019	Active comparator	Day 1 and 22: standard dose SCB-2019 with CpG 1018/alum adjuvant Receives: Biological: candidate vaccine, SCB-2020S

What is being measured

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

Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Measured: Days 36
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Measured: Day 36
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to B.1.351 variant
Measured: Day 36/Day 1

Secondary outcomes (19)

Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to Wuhan strain
Measured: Day 36
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to Wuhan strain
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Measured: Day 36
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to Wuhan strain
Measured: Day 36/Day 1
Geometric mean titer (GMT) of antibody titers specific to SCB-2019 antigen
Measured: Day 36
Proportion of subjects achieving seroconversion of antibodies specific to SCB-2019
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Measured: Day 36
Geometric mean fold rise (GMFR) of antibodies specific to SCB-2019
Measured: Day 36/Day 1
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Measured: Day 205
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Measured: Day 205
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to B.1.351 variant
Measured: Day 205/Day 1
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to Wuhan strain
Measured: Day 205
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to Wuhan strain
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Measured: Day 205
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to Wuhan strain
Measured: Day 205/Day 1
Geometric mean titer (GMT) of antibody titers specific to SCB-2019 antigen
Measured: Day 205
Proportion of subjects achieving seroconversion of antibodies specific to SCB-2019
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Measured: Day 205
Geometric mean fold rise (GMFR) of antibodies specific to SCB-2019
Measured: Day 205/Day 1
Reactogenicity of the vaccines as indicated by the occurrence of solicited local reactions and solicited systemic adverse events.
Percentage of participants with local injection site reactions (pain, redness, swelling) and systemic adverse events (fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever)
Measured: 7 days after each dose
Safety of the vaccines in terms of the occurrence of unsolicited adverse events
Percentage of participants with any adverse event other that those listed above as solicited adverse events
Measured: Up to 21 days after second dose (Day 43)
Safety of the vaccines in terms of the occurrence of medically attended adverse events (MAAEs), serious adverse events (SAEs), adverse events leading to discontinuation from study, and adverse events of special interest (AESI).
Percentage of participants with any adverse events in this category
Measured: through study completion, an average of 7 months
Proportion of subjects with abnormal markers of hematology, biochemistry and coagulation parameters
Measured: Day 29

Timeline

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

Aug 2021Apr 2022

First posted6 Jul 2021
Study startAug 2021 (estimated)
Primary completionApr 2022 (estimated)
Study completionApr 2022 (estimated)

Why it stopped: sponsor decided to withdrawn the study as development strategy has changed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
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: NCT04950751
Sponsor's protocol ID: CLO-SCB-2020-001
Status last verified: Sep 2021
First submitted: 17 Jun 2021
Last updated: 10 Sep 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observer-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults
ClinicalTrials.gov ID: NCT04950751
Acronym / sponsor ID: CLO-SCB-2020-001
Conditions: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: sponsor decided to withdrawn the study as development strategy has changed
Enrolment: 0 participants (actual)
Lead sponsor: Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
Study start: Aug 2021 (estimated)
Primary completion: Apr 2022 (estimated)
Study completion: Apr 2022 (estimated)
First posted: 6 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
SCB-2020S Standard Dose	Experimental	Biological: candidate vaccine, SCB-2020SDay 1 and 22: standard dose SCB-2020S with CpG 1018/alum adjuvant
SCB-2020S Low Antigen Dose	Experimental	Biological: candidate vaccine, SCB-2020SDay 1 and 22: low dose SCB-2020S with CpG 1018/alum adjuvant
SCB-2020S Low Adjuvant Dose	Experimental	Biological: candidate vaccine, SCB-2020SDay 1 and 22: standard dose SCB-2020S with low dose CpG 1018/alum adjuvant
SCB-2020S Mixed Series	Experimental	Biological: candidate vaccine, SCB-2020SDay 1 (Dose 1) standard dose SCB-2020S with CpG 1018/alum adjuvant and Day 22 Dose 2) standard dose SCB-2020S with alum adjuvant
SCB-2019	Active comparator	Biological: candidate vaccine, SCB-2020SDay 1 and 22: standard dose SCB-2019 with CpG 1018/alum adjuvant

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

1. Male or female ≥18 years of age
2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
3.Individuals are willing and able to give an informed consent, prior to screening
4. Healthy participants or participants with pre-existing medical conditions* who are in a stable medical condition. (*A stable medical condition is defined as disease not requiring significant change or hospitalization for worsening disease during the 3 months before enrollment.)
5. Female participants of childbearing potential may be enrolled in the study, if the participant has practiced adequate contraception for 30 days prior to vaccination and has a negative pregnancy test on the day of vaccination and has agreed to continue adequate contraception for 3 months after the last vaccination

Key exclusion criteria (19 listed)

1. Individuals with body temperature >37.5°C (axillary), 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. Individuals with laboratory-confirmed SARS-CoV-2 infection [as defined by reverse transcriptase polymerase chain reaction (RT-PCR) assay or Rapid COVID Antigen Test or an equivalent at Visit 1] or with history of COVID-19.
3. Individuals seropositive at Baseline for SARS-CoV-2.
4.Individuals who have received an investigational or authorized COVID-19 vaccine prior to Day 1, or plan to receive COVID-19 vaccine during the study period.
5. Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease [e.g., malignancy, human immunodeficiency virus (HIV) infection] or immunosuppressive/cytotoxic therapy (e.g., systemic corticosteroids, medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 3 months prior to Day 1.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
candidate vaccine, SCB-2020Sa recombinant SARS-Co-2 trimeric S-protein (from B.1.351 variant) subunit vaccine for COVID-19	Biological	SCB-2019, SCB-2020S Low Adjuvant Dose, SCB-2020S Low Antigen Dose, SCB-2020S Mixed Series, SCB-2020S Standard Dose

Primary outcome

Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Time frame: Days 36
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Time frame: Day 36
Seroconversion rate (percentage of participants with a ≥4-fold increase in titer from that at Day 1 (or from LLoQ if Day 1 titer <LLoQ).
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to B.1.351 variant
Time frame: Day 36/Day 1

19 secondary outcomes

Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to Wuhan strain
Time frame: Day 36
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to Wuhan strain
Time frame: Day 36
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to Wuhan strain
Time frame: Day 36/Day 1
Geometric mean titer (GMT) of antibody titers specific to SCB-2019 antigen
Time frame: Day 36
Proportion of subjects achieving seroconversion of antibodies specific to SCB-2019
Time frame: Day 36
Geometric mean fold rise (GMFR) of antibodies specific to SCB-2019
Time frame: Day 36/Day 1
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Time frame: Day 205
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to B.1.351 variant
Time frame: Day 205
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to B.1.351 variant
Time frame: Day 205/Day 1
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to Wuhan strain
Time frame: Day 205
Proportion of subjects achieving seroconversion of SARS-CoV-2 neutralising antibodies to Wuhan strain
Time frame: Day 205
Geometric mean fold rise (GMFR) of SARS-Cov-2 neutralising antibodies to Wuhan strain
Time frame: Day 205/Day 1
Geometric mean titer (GMT) of antibody titers specific to SCB-2019 antigen
Time frame: Day 205
Proportion of subjects achieving seroconversion of antibodies specific to SCB-2019
Time frame: Day 205
Geometric mean fold rise (GMFR) of antibodies specific to SCB-2019
Time frame: Day 205/Day 1
Reactogenicity of the vaccines as indicated by the occurrence of solicited local reactions and solicited systemic adverse events.
Time frame: 7 days after each dose
Safety of the vaccines in terms of the occurrence of unsolicited adverse events
Time frame: Up to 21 days after second dose (Day 43)
Safety of the vaccines in terms of the occurrence of medically attended adverse events (MAAEs), serious adverse events (SAEs), adverse events leading to discontinuation from study, and adverse events of special interest (AESI).
Time frame: through study completion, an average of 7 months
Proportion of subjects with abnormal markers of hematology, biochemistry and coagulation parameters
Time frame: Day 29

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing candidate vaccine, SCB-2020S in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty.

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 6 inclusion and 19 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies to B.1.351 variant (time frame: Days 36). 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 NCT04950751.

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 10 Sep 2021.