First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
NCT ID: NCT06194318
Last Updated: 2025-06-06
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
160 participants
INTERVENTIONAL
2023-12-13
2025-05-07
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.
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
NCT06843317
Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine
NCT01290419
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
NCT06067230
A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
NCT06573281
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
NCT06850051
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
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
group 1 (SCB-1019 low dose with Alum; young adults)
4 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1
Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
group 2 (Placebo; young adults)
2 young adults (18-59 years old) will receive Placebo at Day 1
placebo
placebo
group 3 (SCB-1019 high dose with Alum; Young Adults)
4 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1
Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
group 4 (Placebo; young adults)
2 young adults (18-59 years old) will receive Placebo at Day 1
placebo
placebo
group 5 (SCB-1019 low dose without Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1
Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
group 6 (SCB-1019 low dose with Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1
Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
group 7 (Placebo; older adults)
4 older adults (60-85 years old) will receive Placebo at Day 1
placebo
placebo
group 8 (SCB-1019 high dose without Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1
Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
group 9 (SCB-1019 high dose with Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1
Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
group 10 (Placebo; older adults)
4 older adults (60-85 years old) will receive Placebo at Day 1
placebo
placebo
Group 11 (SCB-1019T high dose without Alum; older adults)
30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day
candidate vaccine, SCB-1019T
The SCB-1019T vaccines contain RSV F protein subunits from the two dominant circulating strains, A and B strain. Antigens are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
Group 12 (AREXVY; older adults)
30 older adults (60-85 years old) will receive AREXVY at Day 1
AREXVY
AREXVY is a FDA-approved respiratory syncytial virus (RSV) vaccine for adults aged 60 and older. Developed by GSK, it targets the prefusion F glycoprotein to protect against lower respiratory tract disease caused by RSV.
Group 13 (Placebo; older adults)
10 older adults (60-85 years old) will receive Placebo at Day 1
placebo
placebo
Group 14 (SCB-1019T mid dose with Alum; older adults)
30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1
candidate vaccine, SCB-1019T
The SCB-1019T vaccines contain RSV F protein subunits from the two dominant circulating strains, A and B strain. Antigens are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Candidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
placebo
placebo
candidate vaccine, SCB-1019T
The SCB-1019T vaccines contain RSV F protein subunits from the two dominant circulating strains, A and B strain. Antigens are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
AREXVY
AREXVY is a FDA-approved respiratory syncytial virus (RSV) vaccine for adults aged 60 and older. Developed by GSK, it targets the prefusion F glycoprotein to protect against lower respiratory tract disease caused by RSV.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
3. Individuals willing and able to give an informed consent, prior to screening. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included.
Exclusion Criteria
2. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
3. Any progressive unstable or uncontrolled clinical conditions.
4. Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
18 Years
85 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.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher Rook, MD
Role: PRINCIPAL_INVESTIGATOR
CMAX Clinical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fusion Clinical Research
Adelaide, Southern Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLO-SCB-1019-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.