COVID-19Phase 2NCT04954131
Immunogenicity and Safety Study of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adultsin China
A Phase 2 study testing Candidate Vaccine, SCB-2019 in people with COVID-19, run by Zhejiang Clover Biopharmaceuticals, Inc. at 2 sites in China.
Trial summary
The purpose of this clinical study, CLO-SCB-2019-010, is to assess the immunogenicity, reactogenicity and safety of the SCB-2019 vaccine in Chinese participants, and to show the comparability of the immune response versus randomly selected individuals who participated in the large-scale efficacy study with the… 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-2019
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 766 participants
- Where
- 2 sitesChina
- Study dates
- 10 Aug 2021to 15 Nov 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
- Male or female ≥18 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. (A stable medical condition is defined as medication not requiring major change for specific past medical condition, not receive surgery or minimal invasive medical intervention, and without hospitalization or ER visit during the 3 months before enrollment.)
- 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 6 months after the last vaccination.
- Male participants must agree to employ acceptable contraception from the day of the first dose of the study vaccine/placebo until 6 months after the last dose of the study vaccine/placebo and also refrain from donating sperm during this period.
Who cannot join
- Individuals with fever >37.3°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.
- Individuals with laboratory-confirmed SARS-CoV-2 infection [as defined by reverse transcriptase polymerase chain reaction (RT-PCR) assay or Rapid COVID-19 Antigen Test or an equivalent at Visit 1] or with history of COVID-19, or individual with COVID-19 pandemic area contaction confirmed with inspection or health code on cellphone.
- 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.
- 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.
- Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
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- 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-2019 components as outlined in the latest IB].
- 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 Day 53.
- Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular 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 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
2 sites in 1 country.
China2 sites
Sichuan Center for disease control
Chengdu, Sichuan
Shanxi Center for Disease Control and prevention
Taiyuan, Shanxi
About this study
Official title: A Multi-center, Double-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of CpG 1018/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) in Individuals Aged 18 Years and Older in China
The purpose of this clinical study, CLO-SCB-2019-010, is to assess the immunogenicity, reactogenicity and safety of the SCB-2019 vaccine in Chinese participants, and to show the comparability of the immune response versus randomly selected individuals who participated in the large-scale efficacy study with the SCB-2019 vaccine (Study CLO-SCB-2019-003).
- Conditions
- COVID-19
- Being tested
- Candidate Vaccine, SCB-2019, Placebo
- 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-2019Biological
30 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants
PlaceboOther
Saline solution (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| SCB-2019 vaccine | Experimental | Investigational SCB-2019 vaccine contains 30 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants, in each 0.5 mL dose Receives: Biological: Candidate Vaccine, SCB-2019 |
| Placebo | Placebo comparator | Saline solution (0.9%) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT ratio of GMT-CLO-SCB-2019-010 over GMT-CLO-SCB-2019-003
To demonstrate that SCB-2019 vaccine in this study of Chinese participants elicits immune response that is non-inferior to that in a randomly selected subset of participants of the CLO-SCB-2019-003 clinical study, as measured by virus neutralization assay
Measured: Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start10 Aug 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2022 (estimated)
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
- 766 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Clover Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954131
- Sponsor's protocol ID
- CLO-SCB-2019-010
- Status last verified
- Feb 2022
- First submitted
- 6 Jul 2021
- Last updated
- 10 Mar 2022
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Controlled, Phase 2 Study to Evaluate the Immunogenicity and Safety of CpG 1018/Alum-adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) in Individuals Aged 18 Years and Older in China
- ClinicalTrials.gov ID
- NCT04954131
- Acronym / sponsor ID
- CLO-SCB-2019-010
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 766 participants (actual)
- Lead sponsor
- Zhejiang Clover Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 8 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.
The purpose of this clinical study, CLO-SCB-2019-010, is to assess the immunogenicity, reactogenicity and safety of the SCB-2019 vaccine in Chinese participants, and to show the comparability of the immune response versus randomly selected individuals who participated in the large-scale efficacy study with the SCB-2019 vaccine (Study CLO-SCB-2019-003).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCB-2019 vaccine | Experimental | Biological: Candidate Vaccine, SCB-2019Investigational SCB-2019 vaccine contains 30 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants, in each 0.5 mL dose |
| Placebo | Placebo comparator | Other: PlaceboSaline solution (0.9%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥18 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. (A stable medical condition is defined as medication not requiring major change for specific past medical condition, not receive surgery or minimal invasive medical intervention, and without hospitalization or ER visit during the 3 months before enrollment.)
- 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 6 months after the last vaccination.
Key exclusion criteria (14 listed)
- Individuals with fever >37.3°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.
- Individuals with laboratory-confirmed SARS-CoV-2 infection [as defined by reverse transcriptase polymerase chain reaction (RT-PCR) assay or Rapid COVID-19 Antigen Test or an equivalent at Visit 1] or with history of COVID-19, or individual with COVID-19 pandemic area contaction confirmed with inspection or health code on cellphone.
- 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.
- 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.
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-201930 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants | Biological | SCB-2019 vaccine |
| PlaceboSaline solution (0.9%) | Other | Placebo |
Primary outcome
GMT ratio of GMT-CLO-SCB-2019-010 over GMT-CLO-SCB-2019-003
Time frame: Day 36
To demonstrate that SCB-2019 vaccine in this study of Chinese participants elicits immune response that is non-inferior to that in a randomly selected subset of participants of the CLO-SCB-2019-003 clinical study, as measured by virus neutralization assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candidate Vaccine, SCB-2019 in people with COVID-19, run by Zhejiang Clover Biopharmaceuticals, Inc. at 2 sites in China.
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 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 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?
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?
GMT ratio of GMT-CLO-SCB-2019-010 over GMT-CLO-SCB-2019-003 (time frame: Day 36). 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 10 Mar 2022.