First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
- Summary
- First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
- Short title
- First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
- Official title
- Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-05-07
- First posted
- 2024-01-08
- Registry last updated
- 2025-06-06
- Primary completion date
- 2025-02-26
- Start date
- 2023-12-13
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Clover Biopharmaceuticals AUS Pty
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06194318
- ClinicalTrials.gov ID
- NCT06194318
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine
Timeframe: Within 7 days after vaccination
Proportion of participants with local and systemic solicited AEs
Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Timeframe: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Timeframe: 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
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Timeframe: Screening and Day 8
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Healthy volunteers
- Yes
- 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.
- Acute disease or fever (≥38°C) at time of vaccination.
- History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
- Any progressive unstable or uncontrolled clinical conditions.
- Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
Please refer to Protocol for full list of Inclusion and Exclusion criteria.
- Fusion Clinical ResearchAdelaide, Australia
- Linear Clinical ResearchNedlands, Australia