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

Last updated: June 4, 2025
Sponsor: Clover Biopharmaceuticals AUS Pty
Overall Status: Completed

Phase

1

Condition

Respiratory Syncytial Virus (Rsv)

Common Cold

Throat And Tonsil Infections

Treatment

AREXVY

candidate vaccine, SCB-1019T

placebo

Clinical Study ID

NCT06194318
CLO-SCB-1019-001
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female participants 60 to 85 years of age at the screening visit.

  2. Individuals willing and able to comply with study requirements, including allscheduled visits, vaccination, laboratory tests, and other study procedures.

  3. Individuals willing and able to give an informed consent, prior to screening.Healthy participants as determined by medical history, physical examination, andclinical judgment of the investigator; participants with pre-existing stable medicalconditions can be included.

Exclusion

Exclusion Criteria:

  1. Acute disease or fever (≥38°C) at time of vaccination.

  2. History of a severe adverse reaction associated with a vaccine or severe allergicreaction (e.g., anaphylaxis) to any component of the study vaccines.

  3. Any progressive unstable or uncontrolled clinical conditions.

  4. Any progressive or severe neurologic disorder, seizure disorder, or history ofGuillain-Barré syndrome.

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Study Design

Total Participants: 160
Treatment Group(s): 4
Primary Treatment: AREXVY
Phase: 1
Study Start date:
December 13, 2023
Estimated Completion Date:
May 07, 2025

Study 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

Connect with a study center

  • Fusion Clinical Research

    Adelaide, Southern Australia 5067
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

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