RSV InfectionPhase 1NCT06843317
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
A Phase 1 study testing Candidate vaccine, SCB-1019T and AREXVY in people with RSV Infection, run by Clover Biopharmaceuticals USA, LLC at 5 sites in United States.
Trial summary
CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed. 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
- What is being tested?
- 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
- 5 sitesUnited States
- Study dates
- 21 Mar 2025to 3 Jun 2026
- Phase
- Phase 1
- 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 60-85 years of age at the screening visit and who received AREXVY before.
- Individuals are 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 (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Who cannot join
- Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
- Recurrent or un-controlled neurological disorders or seizures.
- Serious or unstable chronic illnesses
- Any history of dementia or any medical condition that moderately or severely impairs cognition
- History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
AMR Fort Myers
Fort Myers, Florida, 33912
Pedro Ylisastigui, MD, 615-591-0211, amrteam@amrllc.com
- Recruiting
AMR Kansas City
Kansas City, Missouri, 64114
Martha Sue Fanning, MD, 615-591-0211, amrteam@amrllc.com
- Recruiting
Knoxville
Knoxville, Tennessee, 37909
Jerry B. Punch, MD, 615-591-0211, amrteam@amrllc.com
- Recruiting
AMR Lexington
Lexington, Kentucky, 40509
Mark Adams, MD, 615-591-0211, amrteam@amrllc.com
- Recruiting
AMR Phoenix
Phoenix, Arizona, 85282
William Reedy, MD, 615-591-0211, amrteam@amrllc.com
About this study
Official title: A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before
CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.
Read the detailed description
The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.
- Conditions
- RSV Infection
- Being tested
- Candidate vaccine, SCB-1019T, AREXVY, placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candidate vaccine, SCB-1019TBiological
SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.
AREXVYBiological
positive comparator
placeboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (SCB-1019T) | Experimental | 50 adults to receive low dose SCB-1019T at Day 1 Receives: Biological: Candidate vaccine, SCB-1019T |
| Group 2 (SCB-1019T) | Experimental | 50 adults to receive high dose SCB-1019T at Day 1 Receives: Biological: Candidate vaccine, SCB-1019T |
| Group 3 (AREXVY) | Active comparator | 50 adults to receive AREXVY at Day 1 Receives: Biological: AREXVY |
| Group 4 (Placebo) | Placebo comparator | 10 adults to receive Placebo at Day 1 Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Proportion of participants with local and systemic solicited AEs
Measured: Within 7 days after vaccination
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Proportion of participants with unsolicited AEs
Measured: Within 28 days after vaccination
To evaluate the safety and reactogenicity of revaccination with SCB-1019T 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start21 Mar 2025
- Primary completion3 Mar 2026 (estimated)
- Study completion3 Jun 2026 (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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clover Biopharmaceuticals USA, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843317
- Sponsor's protocol ID
- CLO-SCB-1019-002
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 14 May 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before
- ClinicalTrials.gov ID
- NCT06843317
- Acronym / sponsor ID
- CLO-SCB-1019-002
- Conditions
- RSV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Clover Biopharmaceuticals USA, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 3 Mar 2026 (estimated)
- Study completion
- 3 Jun 2026 (estimated)
- First posted
- 24 Feb 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.
CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.
Detailed description
The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (SCB-1019T) | Experimental | Biological: Candidate vaccine, SCB-1019T50 adults to receive low dose SCB-1019T at Day 1 |
| Group 2 (SCB-1019T) | Experimental | Biological: Candidate vaccine, SCB-1019T50 adults to receive high dose SCB-1019T at Day 1 |
| Group 3 (AREXVY) | Active comparator | Biological: AREXVY50 adults to receive AREXVY at Day 1 |
| Group 4 (Placebo) | Placebo comparator | Other: placebo10 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 60-85 years of age at the screening visit and who received AREXVY before.
- Individuals are 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 (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).
- Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Key exclusion criteria (6 listed)
- Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
- Recurrent or un-controlled neurological disorders or seizures.
- Serious or unstable chronic illnesses
- Any history of dementia or any medical condition that moderately or severely impairs cognition
- History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
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-1019TSCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™. | Biological | Group 1 (SCB-1019T), Group 2 (SCB-1019T) |
| AREXVYpositive comparator | Biological | Group 3 (AREXVY) |
| placeboPlacebo Comparator | Other | Group 4 (Placebo) |
Primary outcome
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Time frame: Within 7 days after vaccination
Proportion of participants with local and systemic solicited AEs
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Time frame: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
To evaluate the safety and reactogenicity of revaccination with SCB-1019T 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
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 14 May 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.
5 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-1019T and AREXVY in people with RSV Infection, run by Clover Biopharmaceuticals USA, LLC at 5 sites in United States.
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 6 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
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?
Contact Xuesong Pei, MD ((+86) 18515445890, xuesong.pei@cloverbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine (time frame: Within 7 days after vaccination). The study lists 3 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 14 May 2025.