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

NCT06843317 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • RSV Infection

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

Sponsors & Collaborators

  • Clover Biopharmaceuticals USA, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2026-03-03
Completion
2026-06-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843317 on ClinicalTrials.gov