Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
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
1 other identifier
interventional
160
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 24, 2025
CompletedStudy Start
First participant enrolled
March 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2026
ExpectedMay 14, 2025
February 1, 2025
12 months
February 20, 2025
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Proportion of participants with local and systemic solicited AEs
Within 7 days after vaccination
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Proportion of participants with unsolicited AEs
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
Throughout the study period, from enrollment to 6 months follow up
Study Arms (4)
Group 1 (SCB-1019T)
EXPERIMENTAL50 adults to receive low dose SCB-1019T at Day 1
Group 2 (SCB-1019T)
EXPERIMENTAL50 adults to receive high dose SCB-1019T at Day 1
Group 3 (AREXVY)
ACTIVE COMPARATOR50 adults to receive AREXVY at Day 1
Group 4 (Placebo)
PLACEBO COMPARATOR10 adults to receive Placebo at Day 1
Interventions
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™.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
AMR Phoenix
Phoenix, Arizona, 85282, United States
AMR Fort Myers
Fort Myers, Florida, 33912, United States
AMR Lexington
Lexington, Kentucky, 40509, United States
AMR Kansas City
Kansas City, Missouri, 64114, United States
Knoxville
Knoxville, Tennessee, 37909, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2025
First Posted
February 24, 2025
Study Start
March 21, 2025
Primary Completion
March 3, 2026
Study Completion (Estimated)
June 3, 2026
Last Updated
May 14, 2025
Record last verified: 2025-02