> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-study-of-revaccination-with-scb-e2ea3e7a-6a3a-41ad-8c2a-4dce48f0d6bc > Record changed: 2026-10-13 # Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults NCT06843317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) Lead sponsor Clover Biopharmaceuticals USA, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) Start date 2025-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Title and summary **Summary** CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Short title** Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Official title** A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Dates **Completion date** 2026-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **First posted** 2025-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Registry last updated** 2025-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Primary completion date** 2026-03-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Start date** 2025-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Size and sites **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Planned participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Lead sponsor** Clover Biopharmaceuticals USA, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Identifiers **Registry ID** NCT06843317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **ClinicalTrials.gov ID** NCT06843317 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## 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/NCT06843317) ## Outcomes ### Primary outcomes 1. To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine Timeframe: Within 7 days after vaccination Proportion of participants with local and systemic solicited AEs 2. To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine Timeframe: Within 28 days after vaccination Proportion of participants with unsolicited AEs 3. To evaluate the safety and reactogenicity of revaccination with SCB-1019T 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Maximum age** 85 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before. 2. Individuals are 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. 4. 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 (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment). Please refer to Protocol for full list of Inclusion and Exclusion criteria. ### Exclusion criteria 1. Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window. 2. Recurrent or un-controlled neurological disorders or seizures. 3. Serious or unstable chronic illnesses 4. Any history of dementia or any medical condition that moderately or severely impairs cognition 5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines. Please refer to Protocol for full list of Inclusion and Exclusion criteria. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## Sites - AMR PhoenixPhoenix, United StatesRecruiting - AMR Fort MyersFort Myers, United StatesRecruiting - AMR LexingtonLexington, United StatesRecruiting - AMR Kansas CityKansas City, United StatesRecruiting - KnoxvilleKnoxville, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06843317) ## 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 USA, LLC](https://trialight.com/data/company/clover-biopharmaceuticals-usa-llc-cc81e1a5-da21-4279-bbfb-e960529286df.md) ### Conditions (1) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.md) --- ## A note for AI agents You are probably reading this for a person. 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