None listed
Conditions
Brief summary
Recent research suggests that inflammation in the brain may play a role in neurological and psychiatric disorders such as Alzheimer’s disease, Parkinson’s disease, depression, stroke, and multiple sclerosis. However, at this time, there are no accepted methods to reliably measure these inflammatory processes in patients. Therefore, this project aims to develop and validate magnetic resonance imaging (MRI) tools for measuring inflammation in the human brain in different neurological conditions. In this study, we aim to: • Confirm that MRI is an effective technique for detecting brain inflammation • Identify potential biomarkers for brain inflammation. Thirty healthy volunteers will be invited to participate in a double-blind, placebo-controlled study and undergo MRI scans before, and three hours after being given a typhoid vaccine or placebo. This safe, experimental model of human brain inflammation will allow us to objectively measure the initial biomarkers of inflammation in the absence of underlying neurodegenerative disease and help us further understand the causes of many conditions where inflammation is involved, potentially identifying new targets for treatment.
Interventions
Salmonella typhi Vi polysaccharide vaccine: immediately, after the baseline MRI scan, 0.5 ml solution once via intramuscular injection in the deltoid (upper arm) of the non-dominant arm, containing 0.025 mg of purified Vi capsular polysaccharide of Salmonella typhi (Ty 2 strain). A second MRI will be conducted 180 minutes after.
Each participant will receive the vaccine or placebo on a separate study visit. Each study visit will be at least 7 days apart to allow for a sufficient wash-out perio
Salmonella typhi Vi polysaccharide vaccine: immediately, after the baseline MRI scan, 0.5 ml solution once via intramuscular injection in the deltoid (upper arm) of the non-dominant arm, containing 0.025 mg of purified Vi capsular polysaccharide of Salmonella typhi (Ty 2 strain). A second MRI will be conducted 180 minutes after. Each participant will receive the vaccine or placebo on a separate study visit. Each study visit will be at least 7 days apart to allow for a sufficient wash-out period.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
• Participant is willing and able to give informed consent for participation in the study • In the investigators' opinion, is able and willing to comply with all study requirements
Exclusion criteria
• Any physical or psychiatric illness e.g. rheumatologic/autoimmune diseases, major depressive disorder • Current use of any prescribed medication e.g. anti-inflammatory, immunomodulatory medications • Recreation drug use in the previous six months • Smoking • Contraindications for a typhoid vaccine (known systemic hypersensitivity reaction to any component of TYPHIM Vi or a life-threatening reaction after previous administration of the vaccine or vaccine containing the same substance) • Receiving a typhoid vaccine within the past three years • Receiving any other vaccines within one month • Body-weight <50kg or >120kg. • Inability to speak or read English • Contraindications for MRI scanning • Elevated body temperature (>38.0°C) and/or peripheral signs of acute infection/illness (e.g. sneezing, rhinorrhoea) on the day of the study – can be rescheduled/rescreened at a later date • Any other condition judged by the study team as likely to impact on the ability of the participant to complete the study
Outcome results
None listed