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RecruitingPhase 1NCT06984094

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

Sponsor

Clover Biopharmaceuticals AUS Pty

Enrollment

192 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Respiratory Syncytial Virus VaccinationHuman Metapneumovirus VaccinationParainfluenza Vaccination

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.

Eligibility

Min Age: 65 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria4

  • 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.
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Interventions

BIOLOGICALSCB-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)).

BIOLOGICALSCB-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).

BIOLOGICALSCB-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).

Locations(1)

Fusion Clinical Research

Adelaide, Southern Australia, Australia

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NCT06984094