Respiratory Syncytial Virus Vaccination
Conditions
Keywords
Respiratory Syncytial Virus vaccination
Brief summary
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
Detailed description
A Phase 1, placebo-controlled, randomized, observer-blind, First-in-human Study to describe the Safety, reactogenicity and immunogenicity of a bivalent recombinant RSV vaccines (SCB-1019 and SCB-1019T) in healthy adults
Interventions
BIOLOGICALCandidate vaccine, SCB-1019
The SCB-1019 vaccine contains RSV F protein subunits from the two dominant circulating strains, A strain (SCB-1019A) and B strain (SCB-1019B). SCB-1019A and SCB-1019B are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
BIOLOGICALplacebo
placebo
BIOLOGICALcandidate vaccine, SCB-1019T
The SCB-1019T vaccines contain RSV F protein subunits from the two dominant circulating strains, A and B strain. Antigens are recombinant RSV F-Trimer proteins engineered by fusing the ectodomain of RSV F protein with Trimer-Tag™
BIOLOGICALAREXVY
AREXVY is a FDA-approved respiratory syncytial virus (RSV) vaccine for adults aged 60 and older. Developed by GSK, it targets the prefusion F glycoprotein to protect against lower respiratory tract disease caused by RSV.
Sponsors
Clover Biopharmaceuticals AUS Pty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female participants 60 to 85 years of age at the screening visit. 2. Individuals 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. 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.
Exclusion criteria
1. Acute disease or fever (≥38°C) at time of vaccination. 2. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines. 3. Any progressive unstable or uncontrolled clinical conditions. 4. Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome. Please refer to Protocol for full list of Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine | 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 | 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 | 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 |
Countries
Australia
Outcome results
None listed