SCB-2019 as COVID-19 Vaccine
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.
1 other identifier
interventional
166
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Jun 2020
Longer than P75 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
June 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2021
CompletedFebruary 18, 2022
February 1, 2022
1.3 years
May 25, 2020
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Incidence of solicited adverse events (AEs) after vaccination
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
7 days after the first or second vaccination.
Incidence of unsolicited AEs after vaccination
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Day 1 to Day 50
Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Day 1 to Day 50
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
Day 1 to Day 184
As assessed by serum anti-SCB-2019 IgG antibody titers
Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
Day 1 to Day 184
Secondary Outcomes (4)
Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )
Day 1 to Day 184
Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )
Day 1 to Day 184
Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)
Day 1 to Day 184
Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses
Day 1 to Day 184
Study Arms (27)
Adult Group 1
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg.
Adult Group 2
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
Adult Group 3
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
Adult Group 4
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg .
Adult Group 5
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Adult Group 6
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
Adult Group 7
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg .
Adult Group 8
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
Adult Group 9
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Elderly Group 10
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
Elderly Group 11
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
Elderly Group 12
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Elderly Group 13
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
Elderly Group 14
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
Elderly Group 15
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
SARS-CoV-2 Seropositive Group 16
PLACEBO COMPARATORSARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg.
SARS-CoV-2 Seropositive Group 17
PLACEBO COMPARATORSARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg with AS03 adjuvant.
SARS-CoV-2 Seropositive Group 18
PLACEBO COMPARATORSARS-CoV-2 Seropositive subjects receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Adjuvant Dose Modification: Adult Group 19
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Adjuvant Dose Modification: Adult Group 20
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Adjuvant Dose Modification: Elderly Group 21
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Adjuvant Dose Modification: Elderly Group 22
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Alum Only Adjuvant Group 23
PLACEBO COMPARATORSubjects receive SCB-2019 9 µg with Alum adjuvant only.
Dose Expansion Phase: Adult Group 24
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Dose Expansion Phase: Adult Group 25
PLACEBO COMPARATORAdult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Dose Expansion Phase: Elderly Group 26
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
Dose Expansion Phase: Elderly Group 27
PLACEBO COMPARATORElderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
Interventions
SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
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 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 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.
Eligibility Criteria
You may qualify if:
- Healthy adult male or females, ≥18 years of age at Screening:
- For the adult group: 18 to 54 years, inclusive, and
- For the elderly group: 55 to 75 years, inclusive.
- Individuals who are willing and able to give an informed consent, prior to Screening.
- Individuals who are able to comply with study requirements.
- Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:
- 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.
- 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).
- 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.
- 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.
- 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):
- Serological or ELISA confirmation of SARS-CoV-2;
- No history of severe SARS-CoV-2 symptoms;
- +1 more criteria
You may not qualify if:
- 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 \[Treatment Groups 16 to 18\]).
- Individuals with positive serology test results for SARS-CoV-2 at Screening (excluding the SARS-CoV-2 seropositive treatment group \[Treatment Groups 16 to 18\]).
- Individuals with behavioral or cognitive impairment in the opinion of the Investigator.
- Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.
- Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- Individuals with known or suspected impairment of the immune system, such as:
- 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.
- Receipt of cancer chemotherapy within 5 years prior to Day 1.
- Receipt of immunostimulants or immunosuppressants within 60 days prior to Day 1.
- Known HIV or acquired immune deficiency syndrome (AIDS).
- Subjects with active or prior documented autoimmune disorder (such as potential immune-mediated diseases \[pIMDs\]).
- 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.
- Positive serology test results for hepatitis C virus antibody, HIV antibody, and/or hepatitis B virus surface antigen at Screening.
- Individuals who are pregnant or breastfeeding.
- Individuals who are allergic to any of the study vaccine/placebo components as outlined in the current SCB 2019 IB.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009, Australia
Related Publications (1)
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.
PMID: 33524311DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2020
First Posted
May 28, 2020
Study Start
June 19, 2020
Primary Completion
October 20, 2021
Study Completion
December 8, 2021
Last Updated
February 18, 2022
Record last verified: 2022-02