Validating magnetic resonance imaging (MRI) tools to measure brain inflammation using a typhoid vaccine in healthy adults

Not Applicable

Completed

• Conditions: Immunological response; Inflammatory and Immune System - Other inflammatory or immune system disorders; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12619000738123
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-16
• Study Completion: 2021-05-19
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in magnetisation transfer exchange from magnetisation-weighted MRI scan[3 hours post-vaccine administration];Change in brain temperature measured by echo-planar spectroscopic imaging MRI scan[3 hours post-vaccine administration];Change in diffusion-weighted measures derived from diffusion-weighted MRI scans[3 hours post-vaccine administration]

Secondary Outcome Measures

Name	Time	Method
Change in peripheral interleukin-1 from blood samples, measured using enzyme-linked immunosorbent assay (ELISA)[Three hours post-vaccine administration];Change in peripheral interleukin-6 from blood samples, measured using ELISA [Three hours post-vaccine administration];Change in peripheral interleukin-10 from blood samples, measured using ELISA [Three hours post-vaccination administration ];Change in peripheral tumour necrosis factor from blood samples, measured using ELISA [Three hours post-vaccination administration ];Change in mood states as assessed by the Profile of Mood States (POMS)[Three hours post-vaccination administration ]