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RECRUITING
NCT06843317
PHASE1

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

Sponsor: Clover Biopharmaceuticals USA, LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-03-21

Completion Date

2026-06-03

Last Updated

2025-05-14

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (5)

AMR Phoenix

Phoenix, Arizona, United States

AMR Fort Myers

Fort Myers, Florida, United States

AMR Lexington

Lexington, Kentucky, United States

AMR Kansas City

Kansas City, Missouri, United States

Knoxville

Knoxville, Tennessee, United States