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Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
Sponsor: Clover Biopharmaceuticals AUS Pty
Summary
This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).
Official title: A Phase 1/2, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022, a Combination Recombinant RSV-hMPV Protein Subunit Vaccine Candidate, and SCB-1033, a Combination Recombinant RSV-hMPV-PIV3 Protein Subunit Vaccine Candidate in Healthy Older Adults Aged 60-85 Years
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
612
Start Date
2025-06-18
Completion Date
2028-07
Last Updated
2026-05-20
Healthy Volunteers
Yes
Interventions
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)).
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).
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).
Placebo (saline)
0.9% saline
Locations (3)
Fusion Clinical Research
Adelaide, Southern Australia, Australia
Paratus Clinical Research
Melbourne, Victoria, Australia
Linear Clinical Research
Perth, Western Australia, Australia