Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
A Phase 1/2, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022, a Combination Recombinant RSV-hMPV Protein Subunit Vaccine Candidate, and SCB-1033, a Combination Recombinant RSV-hMPV-PIV3 Protein Subunit Vaccine Candidate in Healthy Older Adults Aged 60-85 Years
1 other identifier
interventional
612
1 country
3
Brief 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).
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
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
May 20, 2026
May 1, 2026
2.7 years
May 14, 2025
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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).
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 (Part 1 and Part 2) or Placebo (Part 3).
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 (Part 1 and Part 2) or placebo (Part 3).
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Throughout the study period, from enrollment up to 2 years follow-up
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2).
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.
Screening and day 8
Study Arms (12)
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
Group 9 (SCB-1022 Formulation 1)
EXPERIMENTAL105 adults to receive formulation 1 of SCB-1022 at Day 1
Group 10 (SCB-1022 Formulation 2)
EXPERIMENTAL105 adults to receive formulation 2 of SCB-1022 at Day 1
Group 11 (SCB-1033)
EXPERIMENTAL105 adults to receive SCB-1033 at Day 1
Group 12 Placebo (saline)
EXPERIMENTAL105 adults to receive placebo 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 (3)
Fusion Clinical Research
Adelaide, Southern Australia, 5067, Australia
Paratus Clinical Research
Melbourne, Victoria, 3070, Australia
Linear Clinical Research
Perth, Western Australia, 6009, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher D Rook, MD
Fusion Clinical Research
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 (Estimated)
March 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share