Actively Recruiting
A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T Vaccine Compared to AREXVY in Adults Previously Vaccinated With AREXVY
Led by Clover Biopharmaceuticals USA, LLC · Updated on 2025-05-14
160
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and immune response of the SCB-1019T vaccine when given as a revaccination to healthy adults aged 60 to 85 years who were previously vaccinated with AREXVY. This Phase 1 study compares SCB-1019T revaccination to AREXVY revaccination and placebo, aiming to understand how these vaccines perform in older adults. The study is overseen by a safety monitoring committee to ensure participant safety. Participants are randomly assigned to one of four groups: a low dose of SCB-1019T, a high dose of SCB-1019T, AREXVY vaccine, or placebo. All vaccinations are given on Day 1. The SCB-1019T vaccine is a novel bivalent recombinant RSV vaccine targeting two main virus strains, while AREXVY is used as an active comparator. The study design allows for evaluation of different vaccine doses and comparison with the original AREXVY vaccine and placebo. During the study, participants will be monitored closely for safety and side effects, especially within 7 and 28 days after vaccination, and throughout a 6-month follow-up period. Assessments include physical exams, laboratory tests, and other procedures to measure immune response and vaccine tolerability. The total participation duration is approximately 6 months, during which data on vaccine safety and immune effects will be collected and analyzed.
CONDITIONS
Brief Title
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 60 to 85 years at screening who previously received AREXVY.
- Willing and able to comply with all study visits, vaccination, laboratory tests, and procedures.
- Able and willing to provide informed consent before screening.
- Healthy participants or those with stable medical conditions not requiring recent therapy changes or hospitalizations within 3 months.
You will not qualify if you...
- Having an acute illness or fever of 38°C or higher at vaccination time; minor illnesses without fever may be allowed.
- Recurrent or uncontrolled neurological disorders or seizures.
- Serious or unstable chronic illnesses.
- History of dementia or medical conditions impairing cognition moderately or severely.
- History of severe allergic reactions or severe adverse events related to vaccines or any vaccine component.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants receive a single dose of either the SCB-1019T vaccine at low or high dose, AREXVY vaccine, or placebo as a revaccination.
1 vaccination visit (in-person)
Duration - Up to 6 months
Participants are monitored for safety, reactogenicity, and immunogenicity after vaccination, including assessments up to 6 months post-vaccination.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 5 locations
1
AMR Phoenix
Phoenix, Arizona, United States, 85282
Actively Recruiting
2
AMR Fort Myers
Fort Myers, Florida, United States, 33912
Actively Recruiting
3
AMR Lexington
Lexington, Kentucky, United States, 40509
Actively Recruiting
4
AMR Kansas City
Kansas City, Missouri, United States, 64114
Actively Recruiting
5
Knoxville
Knoxville, Tennessee, United States, 37909
Actively Recruiting
Research Team
X
Xuesong Pei, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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