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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
192
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 (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 (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).
Fusion Clinical Research
Adelaide, Southern Australia, Australia
RECRUITINGTo evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Proportion of participants with local and systemic solicited AEs
Time frame: Within 7 days after vaccination
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Proportion of participants with unsolicited AEs
Time frame: Within 28 days after vaccination
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Time frame: Throughout the study period, from enrollment to 6 months follow up
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.
Time frame: Screening and day 8
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