None listed
Conditions
Brief summary
This is a prospective randomised trial investigating the immunological effects of two different RSV vaccines in older adults aged 60 years and above. Participants will be randomised to receive a single dose of either the Abrysvo or Arexvy RSV vaccine. Alongside standard antibody and cell mediated immunity assays, detailed exploratory systems biology assays (transcriptomics, epigenetics, lipidomics, metabolomics) and flow cytometry will be performed to investigate the broad immunomodulatory effects of RSV vaccination.
Interventions
Randomised to receive a single 0.5mL dose intramuscularly of the Arexvy RSV vaccine. The vaccine will be administered by a research nurse who will not be directly supervised but will document the vaccine given in the CRF.
Sponsors
Tasmanian Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Men and women aged 60 years and older with or without co-morbidities. Ability to communicate in English. Ability to communicate by mobile telephone and text messaging. Written informed consent to participate in the trial.
Exclusion criteria
Known allergy or contraindication to Abrysvo or Arexvy RSV vaccination. Unlikely to be available for the duration of the study.
Outcome results
None listed