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

NCT06194318 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CLO-SCB-1019-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Respiratory Syncytial Virus Vaccination

Keywords

Respiratory Syncytial Virus vaccination

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (14)

group 1 (SCB-1019 low dose with Alum; young adults)

EXPERIMENTAL

4 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1

Biological: Candidate vaccine, SCB-1019

group 2 (Placebo; young adults)

PLACEBO COMPARATOR

2 young adults (18-59 years old) will receive Placebo at Day 1

Biological: placebo

group 3 (SCB-1019 high dose with Alum; Young Adults)

EXPERIMENTAL

4 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1

Biological: Candidate vaccine, SCB-1019

group 4 (Placebo; young adults)

PLACEBO COMPARATOR

2 young adults (18-59 years old) will receive Placebo at Day 1

Biological: placebo

group 5 (SCB-1019 low dose without Alum; older adults)

EXPERIMENTAL

10 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1

Biological: Candidate vaccine, SCB-1019

group 6 (SCB-1019 low dose with Alum; older adults)

EXPERIMENTAL

10 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1

Biological: Candidate vaccine, SCB-1019

group 7 (Placebo; older adults)

PLACEBO COMPARATOR

4 older adults (60-85 years old) will receive Placebo at Day 1

Biological: placebo

group 8 (SCB-1019 high dose without Alum; older adults)

EXPERIMENTAL

10 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1

Biological: Candidate vaccine, SCB-1019

group 9 (SCB-1019 high dose with Alum; older adults)

EXPERIMENTAL

10 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1

Biological: Candidate vaccine, SCB-1019

group 10 (Placebo; older adults)

PLACEBO COMPARATOR

4 older adults (60-85 years old) will receive Placebo at Day 1

Biological: placebo

Group 11 (SCB-1019T high dose without Alum; older adults)

EXPERIMENTAL

30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day

Biological: candidate vaccine, SCB-1019T

Group 12 (AREXVY; older adults)

ACTIVE COMPARATOR

30 older adults (60-85 years old) will receive AREXVY at Day 1

Biological: AREXVY

Group 13 (Placebo; older adults)

PLACEBO COMPARATOR

10 older adults (60-85 years old) will receive Placebo at Day 1

Biological: placebo

Group 14 (SCB-1019T mid dose with Alum; older adults)

EXPERIMENTAL

30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1

Biological: candidate vaccine, SCB-1019T

Interventions

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™

group 1 (SCB-1019 low dose with Alum; young adults); group 3 (SCB-1019 high dose with Alum; Young Adults); group 5 (SCB-1019 low dose without Alum; older adults); group 6 (SCB-1019 low dose with Alum; older adults); group 8 (SCB-1019 high dose without Alum; older adults); group 9 (SCB-1019 high dose with Alum; older adults)

placebo BIOLOGICAL

placebo

Group 13 (Placebo; older adults); group 10 (Placebo; older adults); group 2 (Placebo; young adults); group 4 (Placebo; young adults); group 7 (Placebo; older adults)

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™

Group 11 (SCB-1019T high dose without Alum; older adults); Group 14 (SCB-1019T mid dose with Alum; older adults)

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.

Group 12 (AREXVY; older adults)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clover Biopharmaceuticals AUS Pty: lead

Study Sites (2)

Fusion Clinical Research

Adelaide, Southern Australia, 5067, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Interventions

arexvy

Study Officials

• Christopher Rook, MD

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: January 8, 2024
• Study Start: December 13, 2023
• Primary Completion: February 26, 2025
• Study Completion: May 7, 2025
• Last Updated: June 6, 2025

Record last verified: 2024-02

Locations

AU (2)