COVID-19Phase 1NCT05228314
Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults
A Phase 1 study testing Candidate vaccine, SCB-2020S, Candidate vaccine, SCB-2019 and Squalene based adjuvant in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 3 sites in South Africa.
Trial summary
This is a phase 1 study to assess the safety and immunogenicity of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine (SCB-2020S vaccine), when administered as 2 dose vaccination series 21 days apart to adults ≥18 to ≤75 years of age. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Candidate vaccine, SCB-2020S, Candidate vaccine, SCB-2019 and Squalene based adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 30 May 2022to 23 Apr 2023
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 to 75 years of age
- Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures
- Individuals are 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.
- Female participants of childbearing potential may be enrolled in the study, if the participant has practiced highly effective method of 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
- 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
- Individuals with body temperature >37.8°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization.
- Body mass index at screening >30 kg/m2
- 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 the screening visit or with known history of COVID-19 within 6 months prior to Day 1
- Individuals who have received an investigational or authorized COVID-19 vaccine within 6 months prior to Day 1, or plan to receive COVID-19 vaccine during the study period
- 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.
- Individuals with any progressive unstable or uncontrolled clinical conditions
Show all 19Show fewer
- Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period
- Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction, e.g., anaphylaxis to any components of the study vaccines
- 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).
- 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
- 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 28 days after the second vaccination
- Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection
- 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
- Administration of intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period
- 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
- Individuals with safety laboratory test results (hematology, biochemistry, and coagulation) with a toxicity score of Grade ≥2 at Screening.
- The participant has a reported or documented history of alcohol abuse or drug addiction (excluding nonprescription health supplements and herbal remedies) within 1 year before the planned day of dose administration
- The participant has a positive test result for drugs of abuse at Screening
- 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
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
Josha Research
Bloemfontein
Global Clinical Trials (Pty) Ltd
Pretoria
Wits Vaccines and Infectious Diseases Analytics (VIDA) Research Unit
Soweto
About this study
Official title: A Phase 1, Observer-blind, Randomized, Controlled, Dose-finding Study to Evaluate the Safety and Immunogenicity of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults 18 to 75 Years of Age
This is a phase 1 study to assess the safety and immunogenicity of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine (SCB-2020S vaccine), when administered as 2 dose vaccination series 21 days apart to adults ≥18 to ≤75 years of age.
- Conditions
- COVID-19
- Being tested
- Candidate vaccine, SCB-2020S, Candidate vaccine, SCB-2019, Squalene based adjuvant, CpG/alum adjuvant
- 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-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19
Candidate vaccine, SCB-2019Biological
a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
Squalene based adjuvantOther
Squalene based adjuvant
CpG/alum adjuvantOther
CpG/alum adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Standard dose SCB-2020S with CpG/alum adjuvant | Experimental | Day 1 and 22 standard dose of SCB-2020S with CpG/alum adjuvant Receives: Biological: Candidate vaccine, SCB-2020S; Other: CpG/alum adjuvant |
| Low dose SCB-2020S with low dose squalene based adjuvant | Experimental | Day 1 and 22 low dose of SCB-2020S with low dose squalene based adjuvant Receives: Biological: Candidate vaccine, SCB-2020S; Other: Squalene based adjuvant |
| Low dose SCB-2020S with standard dose squalene based adjuvant | Experimental | Day 1 and 22 low dose of SCB-2020S with standard dose squalene based adjuvant Receives: Biological: Candidate vaccine, SCB-2020S; Other: Squalene based adjuvant |
| Standard dose SCB-2020S with low dose squalene based adjuvant | Experimental | Day 1 and 22 standard dose of SCB-2020S with low dose squalene based adjuvant Receives: Biological: Candidate vaccine, SCB-2020S; Other: Squalene based adjuvant |
| Standard dose SCB-2020S with standard dose squalene based adjuvant | Experimental | Day 1 and 22 standard dose of SCB-2020S with standard dose squalene based adjuvant Receives: Biological: Candidate vaccine, SCB-2020S; Other: Squalene based adjuvant |
| Standard dose SCB-2019 with CpG/alum adjuvant | Active comparator | Day 1 and 22 standard dose of SCB-20219 with standard CpG/alum adjuvant Receives: Biological: Candidate vaccine, SCB-2019; Other: CpG/alum adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with local and systemic adverse events (AEs) after vaccination with SCB-2020S vaccine.
Proportion of subjects with solicited local and systemic adverse events
Measured: 7 days after each dose
Number of participants with unsolicited AEs after vacccination with SCB-2020S vaccine
Proportion of subjects with unsolicited adverse events
Measured: Up to 28 days after the last vaccination
Number of participants with MAAEs, SAEs, AESIs and AEs leading to discontinuation from study.
Proportion of participants with any adverse events in this category.
Measured: Up to 1 year after the last vaccination
Number of participants with abnormal results in hematology parameters (hemoglobin, platelet count, red blood cell count, total and differential white blood cell count).
Proportion of participants with abnormal results in hematology parameters.
Measured: up to Day 29
Number of participants with abnormal results in biochemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, total protein).
Proportion of participants with abnormal results in biochemistry parameters.
Measured: up to Day 29
Number of participants with abnormal results in coagulation parameters (activated partial thromboplastin, prothrombin time).
Proportion of participants with abnormal results in coagulation parameters.
Measured: up to Day 29
Secondary outcomes (8)
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb)
Measured: Day 1, 22, 36, 90, 205 and 389
Proportion of participants achieving seroconversion for SARS-CoV-2 nAb
Measured: Day 22, 36, 90, 205 and 389
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb
Measured: Day 22, 36, 90, 205 and 389
Proportion of participants with nAb above a certain threshold
Measured: Day 1, 22, 36, 90, 205 and 389
GMT of SCB-2019 Binding Antibody
Measured: Day 1, 22, 36, 90, 205 and 389
Proportion of participants achieving seroconversion for SCB-2019 binding antibody
SCR is the 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 22, 36, 90, 205 and 389
GMFR of SCB-2019 binding antibody
Measured: Day 22, 36, 90, 205 and 389
SCB-2019 binding antibody above lower limit of quantification.
Measured: Day 1, 22, 36, 90, 205 and 389
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start30 May 2022
- Primary completion23 Sep 2022
- Study completion23 Apr 2023
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clover Biopharmaceuticals AUS Pty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228314
- Sponsor's protocol ID
- CLO-SCB-2020S-002
- Status last verified
- Jun 2023
- First submitted
- 24 Dec 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Observer-blind, Randomized, Controlled, Dose-finding Study to Evaluate the Safety and Immunogenicity of Clover Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2020S) in Adults 18 to 75 Years of Age
- ClinicalTrials.gov ID
- NCT05228314
- Acronym / sponsor ID
- CLO-SCB-2020S-002
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 8 Feb 2022 (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.
This is a phase 1 study to assess the safety and immunogenicity of different formulations of the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine (SCB-2020S vaccine), when administered as 2 dose vaccination series 21 days apart to adults ≥18 to ≤75 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard dose SCB-2020S with CpG/alum adjuvant | Experimental | Biological: Candidate vaccine, SCB-2020S, Other: CpG/alum adjuvantDay 1 and 22 standard dose of SCB-2020S with CpG/alum adjuvant |
| Low dose SCB-2020S with low dose squalene based adjuvant | Experimental | Biological: Candidate vaccine, SCB-2020S, Other: Squalene based adjuvantDay 1 and 22 low dose of SCB-2020S with low dose squalene based adjuvant |
| Low dose SCB-2020S with standard dose squalene based adjuvant | Experimental | Biological: Candidate vaccine, SCB-2020S, Other: Squalene based adjuvantDay 1 and 22 low dose of SCB-2020S with standard dose squalene based adjuvant |
| Standard dose SCB-2020S with low dose squalene based adjuvant | Experimental | Biological: Candidate vaccine, SCB-2020S, Other: Squalene based adjuvantDay 1 and 22 standard dose of SCB-2020S with low dose squalene based adjuvant |
| Standard dose SCB-2020S with standard dose squalene based adjuvant | Experimental | Biological: Candidate vaccine, SCB-2020S, Other: Squalene based adjuvantDay 1 and 22 standard dose of SCB-2020S with standard dose squalene based adjuvant |
| Standard dose SCB-2019 with CpG/alum adjuvant | Active comparator | Biological: Candidate vaccine, SCB-2019, Other: CpG/alum adjuvantDay 1 and 22 standard dose of SCB-20219 with standard CpG/alum adjuvant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 to 75 years of age
- Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures
- Individuals are 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.
- Female participants of childbearing potential may be enrolled in the study, if the participant has practiced highly effective method of 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)
- Individuals with body temperature >37.8°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization.
- Body mass index at screening >30 kg/m2
- 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 the screening visit or with known history of COVID-19 within 6 months prior to Day 1
- Individuals who have received an investigational or authorized COVID-19 vaccine within 6 months prior to Day 1, or plan to receive COVID-19 vaccine during the study period
- 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-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19 | Biological | Low dose SCB-2020S with low dose squalene based adjuvant, Low dose SCB-2020S with standard dose squalene based adjuvant, Standard dose SCB-2020S with CpG/alum adjuvant, Standard dose SCB-2020S with low dose squalene based adjuvant, Standard dose SCB-2020S with standard dose squalene based adjuvant |
| Candidate vaccine, SCB-2019a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 | Biological | Standard dose SCB-2019 with CpG/alum adjuvant |
| Squalene based adjuvantSqualene based adjuvant | Other | Low dose SCB-2020S with low dose squalene based adjuvant, Low dose SCB-2020S with standard dose squalene based adjuvant, Standard dose SCB-2020S with low dose squalene based adjuvant, Standard dose SCB-2020S with standard dose squalene based adjuvant |
| CpG/alum adjuvantCpG/alum adjuvant | Other | Standard dose SCB-2019 with CpG/alum adjuvant, Standard dose SCB-2020S with CpG/alum adjuvant |
Primary outcome
Number of participants with local and systemic adverse events (AEs) after vaccination with SCB-2020S vaccine.
Time frame: 7 days after each dose
Proportion of subjects with solicited local and systemic adverse events
Number of participants with unsolicited AEs after vacccination with SCB-2020S vaccine
Time frame: Up to 28 days after the last vaccination
Proportion of subjects with unsolicited adverse events
Number of participants with MAAEs, SAEs, AESIs and AEs leading to discontinuation from study.
Time frame: Up to 1 year after the last vaccination
Proportion of participants with any adverse events in this category.
Number of participants with abnormal results in hematology parameters (hemoglobin, platelet count, red blood cell count, total and differential white blood cell count).
Time frame: up to Day 29
Proportion of participants with abnormal results in hematology parameters.
Number of participants with abnormal results in biochemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, total protein).
Time frame: up to Day 29
Proportion of participants with abnormal results in biochemistry parameters.
Number of participants with abnormal results in coagulation parameters (activated partial thromboplastin, prothrombin time).
Time frame: up to Day 29
Proportion of participants with abnormal results in coagulation parameters.
8 secondary outcomes
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (nAb)
Time frame: Day 1, 22, 36, 90, 205 and 389
Proportion of participants achieving seroconversion for SARS-CoV-2 nAb
Time frame: Day 22, 36, 90, 205 and 389
Geometric Mean Fold Rise (GMFRs) of SARS-CoV-2 nAb
Time frame: Day 22, 36, 90, 205 and 389
Proportion of participants with nAb above a certain threshold
Time frame: Day 1, 22, 36, 90, 205 and 389
GMT of SCB-2019 Binding Antibody
Time frame: Day 1, 22, 36, 90, 205 and 389
Proportion of participants achieving seroconversion for SCB-2019 binding antibody
Time frame: Day 22, 36, 90, 205 and 389
GMFR of SCB-2019 binding antibody
Time frame: Day 22, 36, 90, 205 and 389
SCB-2019 binding antibody above lower limit of quantification.
Time frame: Day 1, 22, 36, 90, 205 and 389
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Candidate vaccine, SCB-2020S, Candidate vaccine, SCB-2019 and Squalene based adjuvant in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty at 3 sites in South Africa.
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: finished, as of the sponsor's last update on 3 Jul 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 South Africa. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with local and systemic adverse events (AEs) after vaccination with SCB-2020S vaccine. (time frame: 7 days after each dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.