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First-in-human Safety and Immunogenicity Study of SCB-1019 in Healthy Adults
This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the bivalent SCB-1019 vaccine candidate with or without aluminium hydroxide in young adults (18-59 years) and older adults (60-85 years).
Study details:
The study design includes an age- and dose-escalation (low/high dose) in two adult age groups (young adults \[18-59 years\] and older adults \[60-85 years\]). Study will be conducted in two parts, part 1 will enrolled young adults and part 2 will enroll older adults. A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants.
Detailed characterization of safety (including safety laboratory evaluation) and immune responses is planned. A placebo will be used as a control. 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-12-13
Primary completion: 2024-10-01
Study completion finish: 2025-05-01
Study type
PREVENTION
Phase
PHASE1
Trial ID
NCT06194318
Intervention or treatment
BIOLOGICAL: Candidate vaccine, SCB-1019
BIOLOGICAL: placebo
Conditions
- • Respiratory Syncytial Virus Infection
Find a site
Closest Location:
Linear Clinical Research
Research sites nearby
Select from list below to view details:
Linear Clinical Research
Nedlands, Western Australia, Australia
Fusion Clinical Research
Adelaide, Southern Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: group 1 (SCB-1019 90µg with Alum; young adults)
| BIOLOGICAL: Candidate vaccine, SCB-1019
|
PLACEBO_COMPARATOR: group 2 (Placebo; young adults)
| BIOLOGICAL: placebo
|
EXPERIMENTAL: group 3 (SCB-1019 360µg with Alum; young adults)
| BIOLOGICAL: Candidate vaccine, SCB-1019
|
PLACEBO_COMPARATOR: group 4 (Placebo; young adults)
| BIOLOGICAL: placebo
|
EXPERIMENTAL: group 5 (SCB-1019 90µg without Alum; older adults)
| BIOLOGICAL: Candidate vaccine, SCB-1019
|
EXPERIMENTAL: group 6 (SCB-1019 90µg with Alum; older adults)
| BIOLOGICAL: Candidate vaccine, SCB-1019
|
PLACEBO_COMPARATOR: group 7 (Placebo; older adults)
| BIOLOGICAL: placebo
|
EXPERIMENTAL: group 8 (SCB-1019 360µg without Alum; older adults)
| BIOLOGICAL: Candidate vaccine, SCB-1019
|
EXPERIMENTAL: group 9 (SCB-1019 360µg with Alum; older adults)
| BIOLOGICAL: Candidate vaccine, SCB-1019
|
PLACEBO_COMPARATOR: group 10 (Placebo; older adults)
| BIOLOGICAL: placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Evaluate the reactogenicity of SCB-1019 vaccine | Proportion of participants with local and systemic solicited AEs | Within 7 days after vaccination |
Evaluate the unsolicited AEs of SCB-1019 vaccine | Proportion of participants with unsolicited AEs | Within 28 days after vaccination |
Evaluate the SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019 vaccine | 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 |
Evaluate the safety and tolerability in hematology parameters of SCB-1019 vaccine | Mean change and shift from baseline in hematology parameters | Screening and Day 8 |
Evaluate the safety and tolerability in biochemistry parameters of SCB-1019 vaccine | Mean change and shift from baseline in biochemistry parameters | Screening and Day 8 |
Evaluate the safety and tolerability in coagulation parameters of SCB-1019 vaccine | Mean change and shift from baseline in coagulation parameters | Screening and Day 8 |
Secondary outcome
Frequently Asked Questions
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