NCT06194318

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Clover Biopharmaceuticals AUS Pty · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Respiratory Syncytial Virus Vaccination

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-13
• Primary completion: 2025-02-26
• Completion: 2025-05-07
• First posted: 2024-01-08
• Last updated: 2025-06-06

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study