Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
- 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.
- Short title
- Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-06-03
- First posted
- 2025-02-24
- Registry last updated
- 2025-05-14
- Primary completion date
- 2026-03-03
- Start date
- 2025-03-21
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Clover Biopharmaceuticals USA, LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06843317
- ClinicalTrials.gov ID
- NCT06843317
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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
To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine
Timeframe: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 60 Years
- Maximum age
- 85 Years
- Healthy volunteers
- Yes
- Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.
- Individuals are 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 (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.
- 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.
- Recurrent or un-controlled neurological disorders or seizures.
- Serious or unstable chronic illnesses
- Any history of dementia or any medical condition that moderately or severely impairs cognition
- 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.
- AMR PhoenixPhoenix, United StatesRecruiting
- AMR Fort MyersFort Myers, United StatesRecruiting
- AMR LexingtonLexington, United StatesRecruiting
- AMR Kansas CityKansas City, United StatesRecruiting
- KnoxvilleKnoxville, United StatesRecruiting