Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
NCT ID: NCT06843317
Last Updated: 2025-05-14
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
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RECRUITING
PHASE1
160 participants
INTERVENTIONAL
2025-03-21
2026-06-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1 (SCB-1019T)
50 adults to receive low dose SCB-1019T at Day 1
Candidate vaccine, SCB-1019T
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™.
Group 2 (SCB-1019T)
50 adults to receive high dose SCB-1019T at Day 1
Candidate vaccine, SCB-1019T
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™.
Group 3 (AREXVY)
50 adults to receive AREXVY at Day 1
AREXVY
positive comparator
Group 4 (Placebo)
10 adults to receive Placebo at Day 1
placebo
Placebo Comparator
Interventions
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Candidate vaccine, SCB-1019T
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™.
AREXVY
positive comparator
placebo
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
2. Individuals are 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.
4. 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).
Exclusion Criteria
2. Recurrent or un-controlled neurological disorders or seizures.
3. Serious or unstable chronic illnesses
4. Any history of dementia or any medical condition that moderately or severely impairs cognition
5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
60 Years
85 Years
ALL
Yes
Sponsors
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Clover Biopharmaceuticals USA, LLC
INDUSTRY
Responsible Party
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Locations
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AMR Phoenix
Phoenix, Arizona, United States
AMR Fort Myers
Fort Myers, Florida, United States
AMR Lexington
Lexington, Kentucky, United States
AMR Kansas City
Kansas City, Missouri, United States
Knoxville
Knoxville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLO-SCB-1019-002
Identifier Type: -
Identifier Source: org_study_id
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