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

Phase 1

Completed

• Conditions: Respiratory Syncytial Virus Vaccination
• Interventions: Biological: Candidate vaccine, SCB-1019; Biological: placebo; Biological: candidate vaccine, SCB-1019T; Biological: AREXVY

• Registration Number: NCT06194318
• Lead Sponsor: Clover Biopharmaceuticals AUS Pty

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-11-17
• Study Start: 2023-12-13
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-08
• Status Verified: 2024-02
• Primary Completion: 2025-02-26
• Study Completion: 2025-05-07
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 3 (SCB-1019 360µg with Alum; young adults)	Candidate vaccine, SCB-1019	4 young adults (18-59 years old) will receive high dose SCB-1019 (360µg, with Alum) at Day 1
group 4 (Placebo; young adults)	placebo	2 young adults (18-59 years old) will receive Placebo at Day 1
group 10 (Placebo; older adults)	placebo	4 older adults (60-85 years old) will receive Placebo at Day 1
group 2 (Placebo; young adults)	placebo	2 young adults (18-59 years old) will receive Placebo at Day 1
group 1 (SCB-1019 90µg with Alum; young adults)	Candidate vaccine, SCB-1019	4 young adults (18-59 years old) will receive low dose SCB-1019 (90µg, with Alum) at Day 1
group 5 (SCB-1019 90µg without Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive low dose SCB-1019 (90µg, without Alum) at Day 1
group 7 (Placebo; older adults)	placebo	4 older adults (60-85 years old) will receive Placebo at Day 1
group 9 (SCB-1019 360µg with Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive high dose SCB-1019 (360µg, with Alum) at Day 1
group 8 (SCB-1019 360µg without Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive high dose SCB-1019 (360µg, without Alum) at Day 1
group 6 (SCB-1019 90µg with Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive low dose SCB-1019 (90µg, with Alum) at Day 1
group 5 (SCB-1019 low dose without Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1
group 6 (SCB-1019 low dose with Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1
group 7 (Placebo; older adults)	placebo	4 older adults (60-85 years old) will receive Placebo at Day 1
Group 11 (SCB-1019T high dose without Alum; older adults)	candidate vaccine, SCB-1019T	30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day
Group 12 (AREXVY; older adults)	AREXVY	30 older adults (60-85 years old) will receive AREXVY at Day 1
Group 13 (Placebo; older adults)	placebo	10 older adults (60-85 years old) will receive Placebo at Day 1
Group 14 (SCB-1019T mid dose with Alum; older adults)	candidate vaccine, SCB-1019T	30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1
group 1 (SCB-1019 low dose with Alum; young adults)	Candidate vaccine, SCB-1019	4 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1
group 8 (SCB-1019 high dose without Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1
group 9 (SCB-1019 high dose with Alum; older adults)	Candidate vaccine, SCB-1019	10 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1
group 10 (Placebo; older adults)	placebo	4 older adults (60-85 years old) will receive Placebo at Day 1
group 2 (Placebo; young adults)	placebo	2 young adults (18-59 years old) will receive Placebo at Day 1
group 3 (SCB-1019 high dose with Alum; Young Adults)	Candidate vaccine, SCB-1019	4 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1
group 4 (Placebo; young adults)	placebo	2 young adults (18-59 years old) will receive Placebo at Day 1

Primary Outcome Measures

Name	Time	Method
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine	Within 7 days after vaccination	Proportion of participants with local and systemic solicited AEs
Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine	Within 28 days after vaccination	Proportion of participants with unsolicited AEs
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine	Screening and Day 8	Mean change and shift from baseline in hematology, biochemistry and coagulation parameters

Trial Locations

Locations (2)

Fusion Clinical Research; 🇦🇺 Adelaide, Southern Australia, Australia

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia