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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04405908




Registration number
NCT04405908
Ethics application status
Date submitted
25/05/2020
Date registered
28/05/2020
Date last updated
18/02/2022

Titles & IDs
Public title
SCB-2019 as COVID-19 Vaccine
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety and Immunogenicity of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for COVID-19 in Healthy Volunteers.
Secondary ID [1] 0 0
CLO-SCB-2019-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SCB-2019
Treatment: Other - SCB-2019 with AS03 adjuvant
Treatment: Other - SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
Treatment: Other - SCB-2019 with Alum adjuvant

Placebo comparator: Adult Group 1 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg.

Placebo comparator: Adult Group 2 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.

Placebo comparator: Adult Group 3 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.

Placebo comparator: Adult Group 4 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg .

Placebo comparator: Adult Group 5 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.

Placebo comparator: Adult Group 6 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.

Placebo comparator: Adult Group 7 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg .

Placebo comparator: Adult Group 8 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.

Placebo comparator: Adult Group 9 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.

Placebo comparator: Elderly Group 10 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.

Placebo comparator: Elderly Group 11 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.

Placebo comparator: Elderly Group 12 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.

Placebo comparator: Elderly Group 13 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.

Placebo comparator: Elderly Group 14 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.

Placebo comparator: Elderly Group 15 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.

Placebo comparator: SARS-CoV-2 Seropositive Group 16 - SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg.

Placebo comparator: SARS-CoV-2 Seropositive Group 17 - SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg with AS03 adjuvant.

Placebo comparator: SARS-CoV-2 Seropositive Group 18 - SARS-CoV-2 Seropositive subjects receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.

Placebo comparator: Adjuvant Dose Modification: Adult Group 19 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.

Placebo comparator: 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.

Placebo comparator: Adjuvant Dose Modification: Elderly Group 21 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.

Placebo comparator: 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.

Placebo comparator: Alum Only Adjuvant Group 23 - Subjects receive SCB-2019 9 µg with Alum adjuvant only.

Placebo comparator: Dose Expansion Phase: Adult Group 24 - Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.

Placebo comparator: 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.

Placebo comparator: Dose Expansion Phase: Elderly Group 26 - Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.

Placebo comparator: 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.


Treatment: Other: SCB-2019
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).

Treatment: Other: 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.

Treatment: Other: 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.

Treatment: Other: SCB-2019 with Alum adjuvant
SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of solicited adverse events (AEs) after vaccination
Timepoint [1] 0 0
7 days after the first or second vaccination.
Primary outcome [2] 0 0
Incidence of unsolicited AEs after vaccination
Timepoint [2] 0 0
Day 1 to Day 50
Primary outcome [3] 0 0
Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)
Timepoint [3] 0 0
Day 1 to Day 50
Primary outcome [4] 0 0
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
Timepoint [4] 0 0
Day 1 to Day 184
Primary outcome [5] 0 0
As assessed by serum anti-SCB-2019 IgG antibody titers
Timepoint [5] 0 0
Day 1 to Day 184
Secondary outcome [1] 0 0
Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )
Timepoint [1] 0 0
Day 1 to Day 184
Secondary outcome [2] 0 0
Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )
Timepoint [2] 0 0
Day 1 to Day 184
Secondary outcome [3] 0 0
Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)
Timepoint [3] 0 0
Day 1 to Day 184
Secondary outcome [4] 0 0
Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses
Timepoint [4] 0 0
Day 1 to Day 184

Eligibility
Key inclusion criteria
1. Healthy adult male or females, =18 years of age at Screening:

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 .
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Individuals with any positive test for SARS-CoV-2 infection, including but not limited to RT-PCR, at Screening (excluding the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).
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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/12/2021
Sample size
Target
Accrual to date
Final
166
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clover Biopharmaceuticals AUS Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double blind, placebo controlled, first-in-human (FIH) study to assess safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered as 2 injections IM in healthy subjects. Each study vaccine dose level will be evaluated with and without adjuvant.
Trial website
https://clinicaltrials.gov/study/NCT04405908
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04405908