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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06984094




Registration number
NCT06984094
Ethics application status
Date submitted
14/05/2025
Date registered
22/05/2025
Date last updated
30/05/2025

Titles & IDs
Public title
First-in-human Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
Scientific title
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
Secondary ID [1] 0 0
CLO-SCB-1033-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Vaccination 0 0
Human Metapneumovirus Vaccination 0 0
Parainfluenza Vaccination 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SCB-1019T
Treatment: Other - SCB-1022
Treatment: Other - SCB-1033

Experimental: Group 1 (SCB-1022 dose level 1) - 24 adults to receive dose level 1 of SCB-1022 at Day 1

Experimental: Group 2 (SCB-1022 dose level 2) - 24 adults to receive dose level 2 of SCB-1022 at Day 1

Experimental: Group 3 (SCB-1033 dose level 1) - 24 adults to receive dose level 1 of SCB-1033 at Day 1

Active comparator: Group 4 (SCB-1019T) - 24 adults to receive SCB-1019T at Day 1

Experimental: Group 5 (SCB-1022 dose level 3) - 24 adults to receive dose level 3 of SCB-1022 at Day 1

Experimental: Group 6 (SCB-1033 dose level 2) - 24 adults to receive dose level 2 of SCB-1033 at Day 1

Experimental: Group 7 (SCB-1033 dose level 3) - 24 adults to receive dose level 3 of SCB-1033 at Day 1

Active comparator: Group 8 (SCB-1019T) - 24 adults to receive SCB-1019T at Day 1


Treatment: Other: 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)).

Treatment: Other: 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).

Treatment: Other: 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).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Timepoint [1] 0 0
Within 7 days after vaccination
Primary outcome [2] 0 0
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Timepoint [2] 0 0
Within 28 days after vaccination
Primary outcome [3] 0 0
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Timepoint [3] 0 0
Throughout the study period, from enrollment to 6 months follow up
Primary outcome [4] 0 0
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Timepoint [4] 0 0
Screening and day 8

Eligibility
Key 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
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Southern Australi
Recruitment hospital [1] 0 0
Fusion Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5067 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clover Biopharmaceuticals AUS Pty
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher D Rook, MD
Address 0 0
Fusion Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Xuesong Pei, MD
Address 0 0
Country 0 0
Phone 0 0
+8618515445890
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06984094