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Clinical Trials in Australia / NCT06984094
Active, not recruiting Phase 1/2

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

NCT06984094 · tracked via the Priya Life Science Australia tracker
Sponsor
Clover Biopharmaceuticals AUS Pty
Phase
Phase 1/2
Started
2025-06-18
Last updated
2026-05-20

Condition(s) studied

RSV InfectionHuman Metapneumovirus InfectionParainfluenza Infection

Investigational drug(s) / intervention(s)

SCB-1019TSCB-1022SCB-1033Placebo (saline)

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

Study 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).

Eligibility

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3). — Within 7 days after vaccination
    Proportion of participants with local and systemic solicited AEs
  • To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3). — Within 28 days after vaccination
    Proportion of participants with unsolicited AEs
  • To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or placebo (Part 3). — Throughout the study period, from enrollment up to 2 years follow-up
    Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
  • To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2). — Screening and day 8
    Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.

Trial sites (3)

FacilityCityRegionStatus
Fusion Clinical Research Adelaide Southern Australia
Paratus Clinical Research Melbourne Victoria
Linear Clinical Research Perth Western Australia

Other trials for the same condition

A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine, LYB005 in Healthy Adults Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06984094 on ClinicalTrials.gov ↗ ← All trials in Australia