Respiratory Syncytial Virus VaccinationPhase 1NCT06194318
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
A Phase 1 study testing Candidate vaccine, SCB-1019, candidate vaccine, SCB-1019T and AREXVY in people with Respiratory Syncytial Virus Vaccination, run by Clover Biopharmaceuticals AUS Pty at 2 sites in Australia.
Trial summary
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Vaccination
- What is being tested?
- Candidate vaccine, SCB-1019, candidate vaccine, SCB-1019T and AREXVY
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesAustralia
- Study dates
- 13 Dec 2023to 7 May 2025
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female participants 60 to 85 years of age at the screening visit.
- Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
- 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.
Who cannot join
- Acute disease or fever (≥38°C) at time of vaccination.
- History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
- Any progressive unstable or uncontrolled clinical conditions.
- Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Fusion Clinical Research
Adelaide, Southern Australia, 5067
Linear Clinical Research
Nedlands, Western Australia, 6009
About this study
Official title: Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
Read the detailed description
A Phase 1, placebo-controlled, randomized, observer-blind, First-in-human Study to describe the Safety, reactogenicity and immunogenicity of a bivalent recombinant RSV vaccines (SCB-1019 and SCB-1019T) in healthy adults
- Conditions
- Respiratory Syncytial Virus Vaccination
- Being tested
- Candidate vaccine, SCB-1019, placebo, candidate vaccine, SCB-1019T, AREXVY
- Keywords
- Respiratory Syncytial Virus vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candidate vaccine, SCB-1019Biological
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™
placeboBiological
placebo
candidate vaccine, SCB-1019TBiological
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™
AREXVYBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| group 1 (SCB-1019 low dose with Alum; young adults) | Experimental | 4 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1 Receives: Biological: Candidate vaccine, SCB-1019 |
| group 2 (Placebo; young adults) | Placebo comparator | 2 young adults (18-59 years old) will receive Placebo at Day 1 Receives: Biological: placebo |
| group 3 (SCB-1019 high dose with Alum; Young Adults) | Experimental | 4 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1 Receives: Biological: Candidate vaccine, SCB-1019 |
| group 4 (Placebo; young adults) | Placebo comparator | 2 young adults (18-59 years old) will receive Placebo at Day 1 Receives: Biological: placebo |
| group 5 (SCB-1019 low dose without Alum; older adults) | Experimental | 10 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1 Receives: Biological: Candidate vaccine, SCB-1019 |
| group 6 (SCB-1019 low dose with Alum; older adults) | Experimental | 10 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1 Receives: Biological: Candidate vaccine, SCB-1019 |
| group 7 (Placebo; older adults) | Placebo comparator | 4 older adults (60-85 years old) will receive Placebo at Day 1 Receives: Biological: placebo |
| group 8 (SCB-1019 high dose without Alum; older adults) | Experimental | 10 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1 Receives: Biological: Candidate vaccine, SCB-1019 |
| group 9 (SCB-1019 high dose with Alum; older adults) | Experimental | 10 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1 Receives: Biological: Candidate vaccine, SCB-1019 |
| group 10 (Placebo; older adults) | Placebo comparator | 4 older adults (60-85 years old) will receive Placebo at Day 1 Receives: Biological: placebo |
| Group 11 (SCB-1019T high dose without Alum; older adults) | Experimental | 30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day Receives: Biological: candidate vaccine, SCB-1019T |
| Group 12 (AREXVY; older adults) | Active comparator | 30 older adults (60-85 years old) will receive AREXVY at Day 1 Receives: Biological: AREXVY |
| Group 13 (Placebo; older adults) | Placebo comparator | 10 older adults (60-85 years old) will receive Placebo at Day 1 Receives: Biological: placebo |
| Group 14 (SCB-1019T mid dose with Alum; older adults) | Experimental | 30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1 Receives: Biological: candidate vaccine, SCB-1019T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine
Proportion of participants with local and systemic solicited AEs
Measured: Within 7 days after vaccination
Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Proportion of participants with unsolicited AEs
Measured: Within 28 days after vaccination
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Measured: Throughout the study period, from enrollment to 6 months follow up
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters
Measured: Screening and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start13 Dec 2023
- Primary completion26 Feb 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus VaccinationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clover Biopharmaceuticals AUS Pty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Rook, MD, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194318
- Sponsor's protocol ID
- CLO-SCB-1019-001
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults
- ClinicalTrials.gov ID
- NCT06194318
- Acronym / sponsor ID
- CLO-SCB-1019-001
- Conditions
- Respiratory Syncytial Virus Vaccination
- Keywords
- Respiratory Syncytial Virus vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 8 Jan 2024 (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.
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
Detailed description
A Phase 1, placebo-controlled, randomized, observer-blind, First-in-human Study to describe the Safety, reactogenicity and immunogenicity of a bivalent recombinant RSV vaccines (SCB-1019 and SCB-1019T) in healthy adults
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| group 1 (SCB-1019 low dose with Alum; young adults) | Experimental | Biological: Candidate vaccine, SCB-10194 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1 |
| group 2 (Placebo; young adults) | Placebo comparator | Biological: placebo2 young adults (18-59 years old) will receive Placebo at Day 1 |
| group 3 (SCB-1019 high dose with Alum; Young Adults) | Experimental | Biological: Candidate vaccine, SCB-10194 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1 |
| group 4 (Placebo; young adults) | Placebo comparator | Biological: placebo2 young adults (18-59 years old) will receive Placebo at Day 1 |
| group 5 (SCB-1019 low dose without Alum; older adults) | Experimental | Biological: Candidate vaccine, SCB-101910 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1 |
| group 6 (SCB-1019 low dose with Alum; older adults) | Experimental | Biological: Candidate vaccine, SCB-101910 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1 |
| group 7 (Placebo; older adults) | Placebo comparator | Biological: placebo4 older adults (60-85 years old) will receive Placebo at Day 1 |
| group 8 (SCB-1019 high dose without Alum; older adults) | Experimental | Biological: Candidate vaccine, SCB-101910 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1 |
| group 9 (SCB-1019 high dose with Alum; older adults) | Experimental | Biological: Candidate vaccine, SCB-101910 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1 |
| group 10 (Placebo; older adults) | Placebo comparator | Biological: placebo4 older adults (60-85 years old) will receive Placebo at Day 1 |
| Group 11 (SCB-1019T high dose without Alum; older adults) | Experimental | Biological: candidate vaccine, SCB-1019T30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day |
| Group 12 (AREXVY; older adults) | Active comparator | Biological: AREXVY30 older adults (60-85 years old) will receive AREXVY at Day 1 |
| Group 13 (Placebo; older adults) | Placebo comparator | Biological: placebo10 older adults (60-85 years old) will receive Placebo at Day 1 |
| Group 14 (SCB-1019T mid dose with Alum; older adults) | Experimental | Biological: candidate vaccine, SCB-1019T30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female participants 60 to 85 years of age at the screening visit.
- Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
- 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.
Key exclusion criteria (5 listed)
- Acute disease or fever (≥38°C) at time of vaccination.
- History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
- Any progressive unstable or uncontrolled clinical conditions.
- Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
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-1019The 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™ | Biological | group 1 (SCB-1019 low dose with Alum; young adults), group 3 (SCB-1019 high dose with Alum; Young Adults), group 5 (SCB-1019 low dose without Alum; older adults), group 6 (SCB-1019 low dose with Alum; older adults), group 8 (SCB-1019 high dose without Alum; older adults), group 9 (SCB-1019 high dose with Alum; older adults) |
| placeboplacebo | Biological | Group 13 (Placebo; older adults), group 10 (Placebo; older adults), group 2 (Placebo; young adults), group 4 (Placebo; young adults), group 7 (Placebo; older adults) |
| candidate vaccine, SCB-1019TThe 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™ | Biological | Group 11 (SCB-1019T high dose without Alum; older adults), Group 14 (SCB-1019T mid dose with Alum; older adults) |
| AREXVYAREXVY 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. | Biological | Group 12 (AREXVY; older adults) |
Primary outcome
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine
Time frame: Within 7 days after vaccination
Proportion of participants with local and systemic solicited AEs
Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Time frame: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Time frame: Throughout the study period, from enrollment to 6 months follow up
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Time frame: Screening and Day 8
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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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.
Christopher Rook, MD principal investigator
CMAX Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Candidate vaccine, SCB-1019, candidate vaccine, SCB-1019T and AREXVY in people with Respiratory Syncytial Virus Vaccination, run by Clover Biopharmaceuticals AUS Pty at 2 sites in Australia.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jun 2025. 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 Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine (time frame: Within 7 days after vaccination). The study lists 4 primary outcomes in all. 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 6 Jun 2025.