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
1 other identifier
interventional
192
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedStudy Start
First participant enrolled
June 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedAugust 8, 2025
August 1, 2025
9 months
May 14, 2025
August 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
Proportion of participants with local and systemic solicited AEs
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
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
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.
Screening and day 8
Study Arms (8)
Group 1 (SCB-1022 dose level 1)
EXPERIMENTAL24 adults to receive dose level 1 of SCB-1022 at Day 1
Group 2 (SCB-1022 dose level 2)
EXPERIMENTAL24 adults to receive dose level 2 of SCB-1022 at Day 1
Group 3 (SCB-1033 dose level 1)
EXPERIMENTAL24 adults to receive dose level 1 of SCB-1033 at Day 1
Group 4 (SCB-1019T)
ACTIVE COMPARATOR24 adults to receive SCB-1019T at Day 1
Group 5 (SCB-1022 dose level 3)
EXPERIMENTAL24 adults to receive dose level 3 of SCB-1022 at Day 1
Group 6 (SCB-1033 dose level 2)
EXPERIMENTAL24 adults to receive dose level 2 of SCB-1033 at Day 1
Group 7 (SCB-1033 dose level 3)
EXPERIMENTAL24 adults to receive dose level 3 of SCB-1033 at Day 1
Group 8 (SCB-1019T)
ACTIVE COMPARATOR24 adults to receive SCB-1019T at Day 1
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fusion Clinical Research
Adelaide, Southern Australia, 5067, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D Rook, MD
Fusion Clinical Research
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2025
First Posted
May 22, 2025
Study Start
June 18, 2025
Primary Completion
March 3, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share