First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults

Phase 1

Not yet recruiting

• Conditions: Respiratory Syncytial Virus Vaccination; Human Metapneumovirus Vaccination; Parainfluenza Vaccination
• Interventions: Biological: SCB-1022; Biological: SCB-1033; Biological: SCB-1019T

• Registration Number: NCT06984094
• Lead Sponsor: Clover Biopharmaceuticals AUS Pty

Brief Summary

This phase 1 study will evaluate the safety, reactogenicity, and immunogenicity of 3 different dose levels of SCB-1022 and SCB-1033 in healthy adults aged 60-85 years.

Detailed Description

The study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-14
• Study First Posted: 2025-05-22
• Last Update Submitted: 2025-05-26
• Last Update Posted: 2025-05-30
• Study Start: 2025-05-31
• Primary Completion: 2026-03-03
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

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.

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

Exclusion Criteria

• Pregnancy or potential to become pregnant during the study.
• Acute disease or fever (≥38°C) at time of vaccination.
• History of Guillain-Barré Syndrome (GBS).
• Recurrent or un-controlled neurological disorders or seizures.
• Serious or unstable chronic illnesses. 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 1 (SCB-1022 dose level 1)	SCB-1022	24 adults to receive dose level 1 of SCB-1022 at Day 1
Group 2 (SCB-1022 dose level 2)	SCB-1022	24 adults to receive dose level 2 of SCB-1022 at Day 1
Group 3 (SCB-1033 dose level 1)	SCB-1033	24 adults to receive dose level 1 of SCB-1033 at Day 1
Group 4 (SCB-1019T)	SCB-1019T	24 adults to receive SCB-1019T at Day 1
Group 5 (SCB-1022 dose level 3)	SCB-1022	24 adults to receive dose level 3 of SCB-1022 at Day 1
Group 6 (SCB-1033 dose level 2)	SCB-1033	24 adults to receive dose level 2 of SCB-1033 at Day 1
Group 7 (SCB-1033 dose level 3)	SCB-1033	24 adults to receive dose level 3 of SCB-1033 at Day 1
Group 8 (SCB-1019T)	SCB-1019T	24 adults to receive SCB-1019T at Day 1

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.	Screening and day 8	Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.

Trial Locations

Locations (1)

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