Trial Review

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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.
Scientific title
The PRotective Effect of Maternal Immunisation on preTerm birth: Underlying mechanisms and Role in newborn immune function
Secondary ID [1] 306689 0
MRFF 2007141
Universal Trial Number (UTN)
Trial acronym
PREMITUR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-term birth 325637 0
Pregnancy 325638 0
Vaccination 325639 0
Condition category
Condition code
Inflammatory and Immune System 322995 322995 0 0
Normal development and function of the immune system
Reproductive Health and Childbirth 322996 322996 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 325268 0
Not applicable
Comparator / control treatment
The control group will be women recruited who do not receive vaccinations in pregnancy
Control group
Active

Outcomes
Primary outcome [1] 330763 0
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
Timepoint [1] 330763 0
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
Secondary outcome [1] 418314 0
Assessment of immune cell levels measured from nasal swabs
Timepoint [1] 418314 0
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.

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311020 0
Government body
Name [1] 311020 0
Department of Health and Aged Care (Medical Research Future Fund)
Country [1] 311020 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 314705 0
None
Name [1] 314705 0
Address [1] 314705 0
Country [1] 314705 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310567 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 310567 0
Research Support Services
Level 2, i Block
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Ethics committee country [1] 310567 0
Australia
Date submitted for ethics approval [1] 310567 0
Approval date [1] 310567 0
21/09/2021
Ethics approval number [1] 310567 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118114 0
Prof Michelle Giles
Address 118114 0
Department of Obstetrics and Gynaecology
Monash Health
Clayton Road
Clayton
VICTORIA 3168
Country 118114 0
Australia
Phone 118114 0
+61 3 95944564
Fax 118114 0
Email 118114 0
michelle.giles@monash.edu
Contact person for public queries
Name 118115 0
Prof Michelle Giles
Address 118115 0
Department of Obstetrics and Gynaecology
Monash Health
Clayton Road
Clayton
VICTORIA 3168
Country 118115 0
Australia
Phone 118115 0
+61 3 95944564
Fax 118115 0
Email 118115 0
michelle.giles@monash.edu
Contact person for scientific queries
Name 118116 0
Prof Michelle Giles
Address 118116 0
Department of Obstetrics and Gynaecology
Monash Health
Clayton Road
Clayton
VICTORIA 3168
Country 118116 0
Australia
Phone 118116 0
+61 3 95944564
Fax 118116 0
Email 118116 0
michelle.giles@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.