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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form, 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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).

Locations (1)

Fusion Clinical Research
Adelaide, Southern Australia, Australia