NCT06984094

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

A Phase 1, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022 and SCB-1033 in Healthy Older Adults Aged 60-85 Years

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Clover Biopharmaceuticals AUS Pty · Industry
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus Vaccination
• Human Metapneumovirus Vaccination
• Parainfluenza Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	SCB-1019T	SCB-1019T (bivalent recombinant RSV vaccine candidate) consists of two recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)) and RSV B strain (SCB-1019T(B)).
BIOLOGICAL	SCB-1022	SCB-1022 (combination recombinant RSV-hMPV vaccine candidate) consists of three recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), and hMPV (SCB-1021).
BIOLOGICAL	SCB-1033	SCB-1033 (combination recombinant RSV-hMPV-PIV3 vaccine candidate) consists of four recombinant protein subunit antigens: RSV A strain (SCB-1019T(A)), RSV B strain (SCB-1019T(B)), hMPV (SCB-1021) and PIV3 (SCB-1020).

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-03-03
• Completion: 2026-06-30
• First posted: 2025-05-22
• Last updated: 2025-08-08

Locations

1 site across 1 country: Australia