RSV InfectionPhase 1/2NCT06984094
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
A Phase 1/2 study testing SCB-1019T, SCB-1022 and SCB-1033 in people with RSV Infection and Human Metapneumovirus Infection, run by Clover Biopharmaceuticals AUS Pty at 3 sites in Australia.
Trial summary
This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3). Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection, Human Metapneumovirus Infection, Parainfluenza Infection
- What is being tested?
- SCB-1019T, SCB-1022 and SCB-1033
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 3 sitesAustralia
- Study dates
- 18 Jun 2025to Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 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.
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Who cannot join
- Pregnancy or potential to become pregnant during the study.
- Acute disease or fever (≥38°C) at time of vaccination.
- History of Guillain-Barré Syndrome (GBS).
- Recurrent or un-controlled neurological disorders or seizures.
- Serious or unstable chronic illnesses. Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Fusion Clinical Research
Adelaide, Southern Australia, 5067
Paratus Clinical Research
Melbourne, Victoria, 3070
Linear Clinical Research
Perth, Western Australia, 6009
About this study
Official title: A Phase 1/2, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022, a Combination Recombinant RSV-hMPV Protein Subunit Vaccine Candidate, and SCB-1033, a Combination Recombinant RSV-hMPV-PIV3 Protein Subunit Vaccine Candidate in Healthy Older Adults Aged 60-85 Years
This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).
Read the detailed description
In Part 1 and Part 2, the study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. Part 3 will descriptively compare SCB-1022 and SCB-1033 against placebo.
The sample size of this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1/2 study. The study will be overseen by a safety monitoring committee.
- Being tested
- SCB-1019T, SCB-1022, SCB-1033, Placebo (saline)
- Keywords
- Respiratory Syncytial Virus vaccination, Human Matapneumovirus vaccination, Parainfluenza vaccination, healthy volunteers
- Medical subject headings
- Respiratory Syncytial Virus Infections, Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCB-1019TBiological
SCB-1019T (bivalent recombinant RSV vaccine candidate) consists of two recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)) and RSV B strain (SCB-1019T(B)).
SCB-1022Biological
SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).
SCB-1033Biological
SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020).
Placebo (saline)Biological
0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (SCB-1022 dose level 1) | Experimental | 24 adults to receive dose level 1 of SCB-1022 at Day 1 Receives: Biological: SCB-1022 |
| Group 2 (SCB-1022 dose level 2) | Experimental | 24 adults to receive dose level 2 of SCB-1022 at Day 1 Receives: Biological: SCB-1022 |
| Group 3 (SCB-1033 dose level 1) | Experimental | 24 adults to receive dose level 1 of SCB-1033 at Day 1 Receives: Biological: SCB-1033 |
| Group 4 (SCB-1019T) | Active comparator | 24 adults to receive SCB-1019T at Day 1 Receives: Biological: SCB-1019T |
| Group 5 (SCB-1022 dose level 3) | Experimental | 24 adults to receive dose level 3 of SCB-1022 at Day 1 Receives: Biological: SCB-1022 |
| Group 6 (SCB-1033 dose level 2) | Experimental | 24 adults to receive dose level 2 of SCB-1033 at Day 1 Receives: Biological: SCB-1033 |
| Group 7 (SCB-1033 dose level 3) | Experimental | 24 adults to receive dose level 3 of SCB-1033 at Day 1 Receives: Biological: SCB-1033 |
| Group 8 (SCB-1019T) | Active comparator | 24 adults to receive SCB-1019T at Day 1 Receives: Biological: SCB-1019T |
| Group 9 (SCB-1022 Formulation 1) | Experimental | 105 adults to receive formulation 1 of SCB-1022 at Day 1 Receives: Biological: SCB-1022 |
| Group 10 (SCB-1022 Formulation 2) | Experimental | 105 adults to receive formulation 2 of SCB-1022 at Day 1 Receives: Biological: SCB-1022 |
| Group 11 (SCB-1033) | Experimental | 105 adults to receive SCB-1033 at Day 1 Receives: Biological: SCB-1033 |
| Group 12 Placebo (saline) | Experimental | 105 adults to receive placebo at Day 1 Receives: Biological: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
Proportion of participants with local and systemic solicited AEs
Measured: Within 7 days after vaccination
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
Proportion of participants with unsolicited AEs
Measured: Within 28 days after vaccination
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or placebo (Part 3).
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Measured: Throughout the study period, from enrollment up to 2 years follow-up
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2).
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.
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 posted22 May 2025
- Study start18 Jun 2025
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clover Biopharmaceuticals AUS Pty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher D Rook, MD, Principal investigator, Fusion Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984094
- Sponsor's protocol ID
- CLO-SCB-1033-001
- Status last verified
- Oct 2026
- First submitted
- 14 May 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022, a Combination Recombinant RSV-hMPV Protein Subunit Vaccine Candidate, and SCB-1033, a Combination Recombinant RSV-hMPV-PIV3 Protein Subunit Vaccine Candidate in Healthy Older Adults Aged 60-85 Years
- ClinicalTrials.gov ID
- NCT06984094
- Acronym / sponsor ID
- CLO-SCB-1033-001
- Keywords
- Respiratory Syncytial Virus vaccination, Human Matapneumovirus vaccination, Parainfluenza vaccination, healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 May 2025 (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.
This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).
Detailed description
In Part 1 and Part 2, the study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. Part 3 will descriptively compare SCB-1022 and SCB-1033 against placebo.
The sample size of this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1/2 study. The study will be overseen by a safety monitoring committee.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Group 1 (SCB-1022 dose level 1) | Experimental | Biological: SCB-102224 adults to receive dose level 1 of SCB-1022 at Day 1 |
| Group 2 (SCB-1022 dose level 2) | Experimental | Biological: SCB-102224 adults to receive dose level 2 of SCB-1022 at Day 1 |
| Group 3 (SCB-1033 dose level 1) | Experimental | Biological: SCB-103324 adults to receive dose level 1 of SCB-1033 at Day 1 |
| Group 4 (SCB-1019T) | Active comparator | Biological: SCB-1019T24 adults to receive SCB-1019T at Day 1 |
| Group 5 (SCB-1022 dose level 3) | Experimental | Biological: SCB-102224 adults to receive dose level 3 of SCB-1022 at Day 1 |
| Group 6 (SCB-1033 dose level 2) | Experimental | Biological: SCB-103324 adults to receive dose level 2 of SCB-1033 at Day 1 |
| Group 7 (SCB-1033 dose level 3) | Experimental | Biological: SCB-103324 adults to receive dose level 3 of SCB-1033 at Day 1 |
| Group 8 (SCB-1019T) | Active comparator | Biological: SCB-1019T24 adults to receive SCB-1019T at Day 1 |
| Group 9 (SCB-1022 Formulation 1) | Experimental | Biological: SCB-1022105 adults to receive formulation 1 of SCB-1022 at Day 1 |
| Group 10 (SCB-1022 Formulation 2) | Experimental | Biological: SCB-1022105 adults to receive formulation 2 of SCB-1022 at Day 1 |
| Group 11 (SCB-1033) | Experimental | Biological: SCB-1033105 adults to receive SCB-1033 at Day 1 |
| Group 12 Placebo (saline) | Experimental | Biological: Placebo (saline)105 adults to receive placebo at Day 1 |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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.
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Key exclusion criteria (5 listed)
- Pregnancy or potential to become pregnant during the study.
- Acute disease or fever (≥38°C) at time of vaccination.
- History of Guillain-Barré Syndrome (GBS).
- Recurrent or un-controlled neurological disorders or seizures.
- Serious or unstable chronic illnesses. 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 |
|---|---|---|
| SCB-1019TSCB-1019T (bivalent recombinant RSV vaccine candidate) consists of two recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)) and RSV B strain (SCB-1019T(B)). | Biological | Group 4 (SCB-1019T), Group 8 (SCB-1019T) |
| SCB-1022SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021). | Biological | Group 1 (SCB-1022 dose level 1), Group 10 (SCB-1022 Formulation 2), Group 2 (SCB-1022 dose level 2), Group 5 (SCB-1022 dose level 3), Group 9 (SCB-1022 Formulation 1) |
| SCB-1033SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020). | Biological | Group 11 (SCB-1033), Group 3 (SCB-1033 dose level 1), Group 6 (SCB-1033 dose level 2), Group 7 (SCB-1033 dose level 3) |
| Placebo (saline)0.9% saline | Biological | Group 12 Placebo (saline) |
Primary outcome
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
Time frame: Within 7 days after vaccination
Proportion of participants with local and systemic solicited AEs
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
Time frame: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or placebo (Part 3).
Time frame: Throughout the study period, from enrollment up to 2 years follow-up
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2).
Time frame: Screening and day 8
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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 D Rook, MD principal investigator
Fusion Clinical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCB-1019T, SCB-1022 and SCB-1033 in people with RSV Infection and Human Metapneumovirus Infection, run by Clover Biopharmaceuticals AUS Pty at 3 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 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3). (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 26 Oct 2026.