First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

February 26, 2025

Study Completion Date

May 7, 2025

Conditions
Respiratory Syncytial Virus Vaccination
Interventions
BIOLOGICAL

Candidate 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™

BIOLOGICAL

placebo

placebo

BIOLOGICAL

candidate 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™

BIOLOGICAL

AREXVY

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.

Trial Locations (2)

5067

Fusion Clinical Research, Adelaide

6009

Linear Clinical Research, Nedlands

All Listed Sponsors
lead

Clover Biopharmaceuticals AUS Pty

INDUSTRY