Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults
ConditionRSV Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60-85
SponsorClover Biopharmaceuticals USA, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Candidate vaccine, SCB-1019T
- AREXVY
- placebo
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov