First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
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™
placebo
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™
Fusion Clinical Research
Adelaide, Southern Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine
Proportion of participants with local and systemic solicited AEs
Time frame: Within 7 days after vaccination
Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Proportion of participants with unsolicited AEs
Time frame: Within 28 days after vaccination
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Time frame: Throughout the study period, from enrollment to 6 months follow up
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters
Time frame: Screening and Day 8
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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.