Skip to main content
OpenTrials
Completed

NCT Number: NCT06194318

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Syncytial Virus Vaccination

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fusion Clinical Research, Adelaide, Southern Australia, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants 60 to 85 years of age at the screening visit.
  • Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
  • Individuals willing and able to give an informed consent, prior to screening. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included.

Exclusion criteria

  • Acute disease or fever (≥38°C) at time of vaccination.
  • History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
  • Any progressive unstable or uncontrolled clinical conditions.
  • Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.

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

Treatment and study plan

Candidate vaccine, SCB-1019

Biological

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™

Placebo

Biological

placebo

candidate vaccine, SCB-1019T

Biological

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™

AREXVY

Biological

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.

Primary outcomes

  1. Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine

    Time frame: Within 7 days after vaccination

    Proportion of participants with local and systemic solicited AEs

  2. Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine

    Time frame: Within 28 days after vaccination

    Proportion of participants with unsolicited AEs

  3. Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine

    Time frame: Throughout the study period, from enrollment to 6 months follow up

    Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study

  4. Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine

    Time frame: Screening and Day 8

    Mean change and shift from baseline in hematology, biochemistry and coagulation parameters

Sponsors and collaborators

Lead sponsor

Clover Biopharmaceuticals AUS Pty

Industry

Registry information

Official study title

Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.