Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
166 participants
INTERVENTIONAL
2020-06-19
2021-12-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
NCT04537208
Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older
NCT04405076
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 Years
NCT04470609
Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
NCT05596045
Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants
NCT05260437
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adult Group 1
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg.
SCB-2019
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
Adult Group 2
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Adult Group 3
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Adult Group 4
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg .
SCB-2019
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
Adult Group 5
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Adult Group 6
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Adult Group 7
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg .
SCB-2019
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
Adult Group 8
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Adult Group 9
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Elderly Group 10
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Elderly Group 11
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Elderly Group 12
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Elderly Group 13
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Elderly Group 14
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Elderly Group 15
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
SARS-CoV-2 Seropositive Group 16
SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg.
SCB-2019
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
SARS-CoV-2 Seropositive Group 17
SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
SARS-CoV-2 Seropositive Group 18
SARS-CoV-2 Seropositive subjects receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Adjuvant Dose Modification: Adult Group 19
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Adjuvant Dose Modification: Adult Group 20
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Adjuvant Dose Modification: Elderly Group 21
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Adjuvant Dose Modification: Elderly Group 22
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Alum Only Adjuvant Group 23
Subjects receive SCB-2019 9 µg with Alum adjuvant only.
SCB-2019 with Alum adjuvant
SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.
Dose Expansion Phase: Adult Group 24
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Dose Expansion Phase: Adult Group 25
Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Dose Expansion Phase: Elderly Group 26
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
Dose Expansion Phase: Elderly Group 27
Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SCB-2019
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
SCB-2019 with AS03 adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
SCB-2019 with Alum adjuvant
SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. For the adult group: 18 to 54 years, inclusive, and
2. For the elderly group: 55 to 75 years, inclusive.
2. Individuals who are willing and able to give an informed consent, prior to Screening.
3. Individuals who are able to comply with study requirements.
4. Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
1. Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to each vaccination. They must be using a highly effective licensed method of birth control for 30 days prior to the first dose of the study vaccine/placebo and must agree to continue such precautions during the study until 60 days after the second dose of the study vaccine/placebo.
2. Women not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (no menses for 12 months and follicle-stimulating hormone \[FSH\] in the postmenopausal range).
3. Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 90 days after the second dose of the study vaccine/placebo and also refrain from donating sperm during this period.
5. General good health based on medical history, physical examination, cardiac health evaluation, and clinical laboratory evaluations. Participants in the elderly population who have medically stable, well-controlled co-morbidities may be enrolled at the discretion of the Investigator.
All clinical laboratory values should be within normal reference ranges unless confirmed by Investigator or delegate as not clinically significant. One repeat evaluation of electrocardiogram (ECG), and clinical laboratory tests will be permitted, at the discretion of the Investigator.
6. Individuals agree to avoid strenuous exercise from Screening to Day 50.
For the SARS-CoV-2 seropositive treatment group only (Treatment Groups 16 to 18):
7. Serological or ELISA confirmation of SARS-CoV-2;
8. No history of severe SARS-CoV-2 symptoms;
9. No SARS-CoV-2 symptoms at the time of the screening .
Exclusion Criteria
2. Individuals with positive serology test results for SARS-CoV-2 at Screening (excluding the SARS-CoV-2 seropositive treatment group \[Treatment Groups 16 to 18\]).
3. Individuals with behavioral or cognitive impairment in the opinion of the Investigator.
4. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
5. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
6. Individuals with known or suspected impairment of the immune system, such as:
1. Use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to Day 1. Use of inhaled, intranasal, or topical corticosteroids is allowed.Note: Systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the study vaccine/placebo.
2. Receipt of cancer chemotherapy within 5 years prior to Day 1.
3. Receipt of immunostimulants or immunosuppressants within 60 days prior to Day 1.
4. Known HIV or acquired immune deficiency syndrome (AIDS).
5. Subjects with active or prior documented autoimmune disorder (such as potential immune-mediated diseases \[pIMDs\]).
6. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study.
7. Positive serology test results for hepatitis C virus antibody, HIV antibody, and/or hepatitis B virus surface antigen at Screening.
8. Individuals who are pregnant or breastfeeding.
9. Individuals who are allergic to any of the study vaccine/placebo components as outlined in the current SCB 2019 IB.
10. Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the date of first administration of the study vaccine/placebo (Day 1).
11. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study.
12. Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3 days of intended study vaccination.
13. Individuals who have a previous confirmed or suspected illness caused by coronaviruses, SARS-CoV-1, SARS-CoV-2, and Middle East Respiratory Syndrome (MERS)-CoV (excluding the SARS-CoV-2 seropositive treatment group \[Treatment Groups 16 to 18\]).
14. Individuals who have received any prior vaccine against a coronavirus, including but not limited to SARS-CoV, SARS-CoV-2, MERS-CoV.
15. Individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days (before or after) the study vaccine/placebos, with the exception of the seasonal influenza vaccine.
16. Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS CoV 2 infection and/or its complications.
17. Individuals with known bleeding diathesis.
18. Individuals with a body mass index \<18.5 kg/m2 or \>35.0 kg/m2.
19. Individuals with a history of drug or alcohol abuse within the past 2 years.
20. Individuals with a history of anaphylaxis or angioedema including but not limited to history of anaphylaxis after any vaccine.
21. Individuals with any condition that, in the opinion of the Investigator, would interfere with the primary study objectives or pose additional subject risk.
22. Individuals who are research staff involved with the clinical study or family/household members of research staff.
23. Individuals must not have donated blood for 2 months prior to Day 1 and must agree to not donate blood for 6 months post Day 1 (receipt of first dose of study vaccine).
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clover Biopharmaceuticals AUS Pty
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, Li P, Liang P, Han HH, Liang J, Clemens R. Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Feb 20;397(10275):682-694. doi: 10.1016/S0140-6736(21)00241-5. Epub 2021 Jan 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLO-SCB-2019-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.