Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000738123
Ethics application status
Approved
Date submitted
6/05/2019
Date registered
16/05/2019
Date last updated
3/03/2022
Date data sharing statement initially provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Validating magnetic resonance imaging (MRI) tools to measure brain inflammation using a typhoid vaccine in healthy adults
Scientific title
Validating MRI tools to measure neuroinflammation in vivo using a typhoid vaccine in healthy adults
Secondary ID [1] 298066 0
None
Universal Trial Number (UTN)
U1111-1224-8965
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunological response 312622 0
Condition category
Condition code
Inflammatory and Immune System 311121 311121 0 0
Other inflammatory or immune system disorders
Neurological 311122 311122 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314328 0
Treatment: Drugs
Comparator / control treatment
Placebo: 0.5 ml 0.9% saline solution administered once via intramuscular injection
Control group
Placebo

Outcomes
Primary outcome [1] 319893 0
Change in magnetisation transfer exchange from magnetisation-weighted MRI scan
Timepoint [1] 319893 0
3 hours post-vaccine administration
Primary outcome [2] 319894 0
Change in brain temperature measured by echo-planar spectroscopic imaging MRI scan
Timepoint [2] 319894 0
3 hours post-vaccine administration
Primary outcome [3] 319895 0
Change in diffusion-weighted measures derived from diffusion-weighted MRI scans
Timepoint [3] 319895 0
3 hours post-vaccine administration
Secondary outcome [1] 370039 0
Change in peripheral interleukin-1 from blood samples, measured using enzyme-linked immunosorbent assay (ELISA)
Timepoint [1] 370039 0
Three hours post-vaccine administration
Secondary outcome [2] 370040 0
Change in peripheral interleukin-6 from blood samples, measured using ELISA
Timepoint [2] 370040 0
Three hours post-vaccine administration
Secondary outcome [3] 370424 0
Change in peripheral interleukin-10 from blood samples, measured using ELISA
Timepoint [3] 370424 0
Three hours post-vaccination administration
Secondary outcome [4] 370425 0
Change in peripheral tumour necrosis factor from blood samples, measured using ELISA
Timepoint [4] 370425 0
Three hours post-vaccination administration
Secondary outcome [5] 370426 0
Change in mood states as assessed by the Profile of Mood States (POMS)
Timepoint [5] 370426 0
Three hours post-vaccination administration

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2020
Actual
12/06/2020
Date of last participant enrolment
Anticipated
Actual
5/05/2021
Date of last data collection
Anticipated
Actual
19/05/2021
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 21455 0
New Zealand
State/province [1] 21455 0
Auckland

Funding & Sponsors
Funding source category [1] 302597 0
Charities/Societies/Foundations
Name [1] 302597 0
Neurological Foundation of New Zealand
Country [1] 302597 0
New Zealand
Funding source category [2] 302688 0
Charities/Societies/Foundations
Name [2] 302688 0
Oakley Mental Health Research Foundation
Country [2] 302688 0
New Zealand
Funding source category [3] 302689 0
Charities/Societies/Foundations
Name [3] 302689 0
Maurice and Phyllis Paykel Trust
Country [3] 302689 0
New Zealand
Funding source category [4] 302690 0
Charities/Societies/Foundations
Name [4] 302690 0
New Zealand Pharmacy Education and Research Foundation
Country [4] 302690 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 302620 0
None
Name [1] 302620 0
Address [1] 302620 0
Country [1] 302620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303232 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 303232 0
Ethics committee country [1] 303232 0
New Zealand
Date submitted for ethics approval [1] 303232 0
16/01/2019
Approval date [1] 303232 0
06/03/2019
Ethics approval number [1] 303232 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92938 0
Dr Joanne Lin
Address 92938 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 92938 0
New Zealand
Phone 92938 0
+64 9 923 2255
Fax 92938 0
Email 92938 0
[email protected]
Contact person for public queries
Name 92939 0
Joanne Lin
Address 92939 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 92939 0
New Zealand
Phone 92939 0
+64 9 923 2255
Fax 92939 0
Email 92939 0
[email protected]
Contact person for scientific queries
Name 92940 0
Joanne Lin
Address 92940 0
School of Pharmacy
The University of Auckland
Private Bag 92019
Auckland 1142
Country 92940 0
New Zealand
Phone 92940 0
+64 9 923 2255
Fax 92940 0
Email 92940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Public sharing of data has not been approved by the ethics committee


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBrain temperature as an indicator of neuroinflammation induced by typhoid vaccine: Assessment using whole-brain magnetic resonance spectroscopy in a randomised crossover study.2022https://dx.doi.org/10.1016/j.nicl.2022.103053
N.B. These documents automatically identified may not have been verified by the study sponsor.