NCT06843317

Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults

A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Clover Biopharmaceuticals USA, LLC · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.

Detailed description

The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.

Conditions

• RSV Infection

Interventions

Type	Name	Description
BIOLOGICAL	Candidate vaccine, SCB-1019T	SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.
BIOLOGICAL	AREXVY	positive comparator
OTHER	placebo	Placebo Comparator

Timeline

• Start date: 2025-03-21
• Primary completion: 2026-03-03
• Completion: 2026-06-03
• First posted: 2025-02-24
• Last updated: 2025-05-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study