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Trial registered on ANZCTR
Registration number
ACTRN12623000170628
Ethics application status
Approved
Date submitted
19/01/2023
Date registered
17/02/2023
Date last updated
17/02/2023
Date data sharing statement initially provided
17/02/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
The PRotective Effect of Maternal Immunisation on preTerm birth: Underlying mechanisms and Role in newborn immune function (PREMITUR) Study.
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Scientific title
The PRotective Effect of Maternal Immunisation on preTerm birth: Underlying mechanisms and Role in newborn immune function
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Secondary ID [1]
306689
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MRFF 2007141
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Universal Trial Number (UTN)
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Trial acronym
PREMITUR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pre-term birth
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Pregnancy
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Vaccination
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Condition category
Condition code
Inflammatory and Immune System
322995
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0
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Normal development and function of the immune system
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Reproductive Health and Childbirth
322996
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0
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Normal pregnancy
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This study will unravel the immune trajectory of pregnancy and the impact maternal immunisation has on the maternal as well as the newborn immune development.
Participants will be asked to provide x5 blood samples over the period of their pregnancy and x2 infant nasal fluid samples up to 6 weeks post partum. Infant samples are taken by the study team at on site appointments
Blood Samples are taken at the following windows:
Visit 1: 10-14 weeks gestation
Visit 2: 20-22 weeks gestation
Visit 3: 26-28 weeks gestation
Visit 4: 34-36 weeks gestation
Visit 5: At birth.
Blood tests will occur on site at the recruiting centre and should coincide with routine antenatal appointments and routine testing.
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Intervention code [1]
325268
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Not applicable
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Comparator / control treatment
The control group will be women recruited who do not receive vaccinations in pregnancy
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Control group
Active
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Outcomes
Primary outcome [1]
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Immune trajectory during pregnancy assed using blood samples and the impact of maternal immunisation on this trajectory.
This is what we need to do as the outcome of interest is the impact of vaccination on the immune trajectory
This is where we will use systems biology to assess the impact of vaccination on the immune trajectory
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Assessment method [1]
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Timepoint [1]
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Blood samples are taken at 5 time points across pregnancy to asses the trajectory during a woman's pregnancy.
These samples are taken at:
10 - 14 weeks gestation - visit 1
20-22 weeks gestation - visit 2
26-28 weeks gestation - visit 3
34-36 weeks gestation - visit 4
Birth - visit 5.
Not all timepoints will be taken in the event a pregnancy is premature. For example, if a woman births at 35 weeks, she will have a visit 1, visit 2, visit 3 and visit 5
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Secondary outcome [1]
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Assessment of immune cell levels measured from nasal swabs
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Assessment method [1]
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Timepoint [1]
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This is assess at two time points. One at birth and the other at 6 weeks of age. Samples are collected by the study team.
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Eligibility
Key inclusion criteria
• Nulliparous women
• Aged 18 to equal to 45 years
• Available for the entire study period
• Gestation between 9 and 22 weeks at time of recruitment.
• Willing and able to comply with all study requirements including timing and/or nature of required assessments and follow up of mother and baby to six weeks post-partum
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Multiparous women
• Multiple pregnancy
• Unable to provide consent
• Concomitant immunosuppressive medication likely to continue beyond first trimester
• Any other significant acute or chronic medical condition that in the opinion of the investigator may interfere with the interpretation of study results or place the participant at increased risk if they participate in the study.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
2/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
400
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Accrual to date
100
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health and Aged Care (Medical Research Future Fund)
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Address [1]
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Department of Health and Aged Care
GPO Box 9848
Canberra ACT 2601
Australia
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Monash Health
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Address
246 Clayton Road
Clayton
Victoria 3168
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash Health Human Research Ethics Committee
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Ethics committee address [1]
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Research Support Services
Level 2, i Block
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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21/09/2021
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Ethics approval number [1]
310567
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Summary
Brief summary
Maternal immunisation, a low cost/high efficacy intervention is recommended for its pathogen specific protection. We believe maternal immunisation has another, massive impact: reduction of preterm birth (PTB). Our overarching question is: how does maternal immunisation alter the immune system in pregnant women and/or their newborn to reduce adverse pregnancy outcomes and enhances the newborn infant’s capacity to protect from infectious diseases during early childhood? To answer this question and potentially impact on the single greatest cause of childhood mortality globally we are conducting a multi-site, prospective observational cohort study collecting maternal and infant biosamples at defined time points during pregnancy and post partum from nulliparous women. We plan to enrol 400 women and apply systems biology to determine the immune trajectory in pregnancy and the impact of maternal immunisation (including influenza, pertussis and/or COVID-19 vaccines) on this trajectory. We also plan to delineate the impact of maternal immunisation on the immune trajectory of the infant.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Michelle Giles
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Address
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Department of Obstetrics and Gynaecology
Monash Health
Clayton Road
Clayton
VICTORIA 3168
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Country
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Australia
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Phone
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+61 3 95944564
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Michelle Giles
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Address
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Department of Obstetrics and Gynaecology
Monash Health
Clayton Road
Clayton
VICTORIA 3168
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Country
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Australia
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Phone
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+61 3 95944564
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Michelle Giles
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Address
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Department of Obstetrics and Gynaecology
Monash Health
Clayton Road
Clayton
VICTORIA 3168
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Country
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Australia
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Phone
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+61 3 95944564
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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