> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/first-in-human-safety-and-immunogenicity-study-of-scb-1019-a0873eb1-7ca0-4d37-bded-2aa8a2f87b8b > Record changed: 2026-10-13 # First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults NCT06194318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) Lead sponsor Clover Biopharmaceuticals AUS Pty Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) Start date 2023-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Title and summary **Summary** First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Short title** First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Official title** Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Dates **Completion date** 2025-05-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **First posted** 2024-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Registry last updated** 2025-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Primary completion date** 2025-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Start date** 2023-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Size and sites **Actual participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Lead sponsor** Clover Biopharmaceuticals AUS Pty Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Identifiers **Registry ID** NCT06194318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **ClinicalTrials.gov ID** NCT06194318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Outcomes ### Primary outcomes 1. Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine Timeframe: Within 7 days after vaccination Proportion of participants with local and systemic solicited AEs 2. Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine Timeframe: Within 28 days after vaccination Proportion of participants with unsolicited AEs 3. Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine Timeframe: Throughout the study period, from enrollment to 6 months follow up Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study 4. Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine Timeframe: Screening and Day 8 Mean change and shift from baseline in hematology, biochemistry and coagulation parameters Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Male and female participants 60 to 85 years of age at the screening visit. 2. Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures. 3. 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. ### Exclusion criteria 1. Acute disease or fever (≥38°C) at time of vaccination. 2. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines. 3. Any progressive unstable or uncontrolled clinical conditions. 4. Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome. Please refer to Protocol for full list of Inclusion and Exclusion criteria. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Sites - Fusion Clinical ResearchAdelaide, Australia - Linear Clinical ResearchNedlands, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06194318) ## Related records ### Drugs (1) - [Respiratory syncytial virus pre-fusion glycoprotein F](https://trialight.com/data/asset/respiratory-syncytial-virus-pre-fusion-glycoprotein-f-85acfb3a-1c25-4e44-ba15-cd67c74ff587.md) ### Lead sponsors (1) - [Clover Biopharmaceuticals AUS Pty](https://trialight.com/data/company/clover-biopharmaceuticals-aus-pty-a8f76b32-97f1-4e58-baa6-469eceb8fe7e.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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