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

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Vaccination
• Intervention / Treatment: Biological: placebo; Biological: Candidate vaccine, SCB-1019; Biological: candidate vaccine, SCB-1019T; Biological: AREXVY

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Southern Australia
    • Adelaide, Southern Australia, Australia, 5067
      • Fusion Clinical Research
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 all scheduled 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, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included.

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 allergic reaction (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 of Guillain-Barré syndrome.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group 2 (Placebo; young adults); 2 young adults (18-59 years old) will receive Placebo at Day 1	Biological: placebo; placebo
Placebo Comparator: group 4 (Placebo; young adults); 2 young adults (18-59 years old) will receive Placebo at Day 1	Biological: placebo; placebo
Placebo Comparator: group 7 (Placebo; older adults); 4 older adults (60-85 years old) will receive Placebo at Day 1	Biological: placebo; placebo
Placebo Comparator: group 10 (Placebo; older adults); 4 older adults (60-85 years old) will receive Placebo at Day 1	Biological: placebo; placebo
Experimental: group 1 (SCB-1019 low dose with Alum; young adults); 4 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1	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™
Experimental: group 3 (SCB-1019 high dose with Alum; Young Adults); 4 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1	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™
Experimental: group 5 (SCB-1019 low dose without Alum; older adults); 10 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1	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™
Experimental: group 6 (SCB-1019 low dose with Alum; older adults); 10 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1	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™
Experimental: group 8 (SCB-1019 high dose without Alum; older adults); 10 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1	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™
Experimental: group 9 (SCB-1019 high dose with Alum; older adults); 10 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1	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™
Experimental: Group 11 (SCB-1019T high dose without Alum; older adults); 30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day	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™
Active Comparator: Group 12 (AREXVY; older adults); 30 older adults (60-85 years old) will receive AREXVY at Day 1	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.
Placebo Comparator: Group 13 (Placebo; older adults); 10 older adults (60-85 years old) will receive Placebo at Day 1	Biological: placebo; placebo
Experimental: Group 14 (SCB-1019T mid dose with Alum; older adults); 30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1	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™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine	Proportion of participants with local and systemic solicited AEs	Within 7 days after vaccination
Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine	Proportion of participants with unsolicited AEs	Within 28 days after vaccination
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine	Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study	Throughout the study period, from enrollment to 6 months follow up
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine	Mean change and shift from baseline in hematology, biochemistry and coagulation parameters	Screening and Day 8

Collaborators and Investigators

• Sponsor: Clover Biopharmaceuticals AUS Pty
• Investigators: Principal Investigator: Christopher Rook, MD, CMAX Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): May 7, 2025

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory Syncytial Virus vaccination
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: CLO-SCB-1019-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No