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

NCT06194318 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-06-06

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Clover Biopharmaceuticals AUS Pty

    lead INDUSTRY

Principal Investigators

  • Christopher Rook, MD · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2025-02-26
Completion
2025-05-07
FDA Drug
Yes

Countries

  • Australia

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 NCT06194318 on ClinicalTrials.gov