RAN BIOLINKS celebrates a milestone in the PREMITUR Study, pioneering maternal immunisation research to reduce preterm births

Wednesday, January 17, 2024

RAN BioLinks team is thrilled to highlight the publication of the clinical protocol and the successful collaboration in the ground-breaking PREMITUR study. This two-year effort focuses on characterizing the underlying mechanisms of maternal immunization during pregnancy and its role in newborn immune function to reduce adverse pregnancy outcomes, particularly preterm births (PTB), identified as the single most significant cause of childhood morbidity and mortality globally. Maternal immunization is, however, recognized as a low-cost and highly effective intervention for pathogen-specific protection, and has shown evidence of reducing preterm births.

The PRotective Effect of Maternal Immunisation on preTerm birth (PREMITUR) study aims to enroll up to 400 pregnant women to understand the immune trajectory during pregnancy and the impact of maternal immunization, including influenza, pertussis, and/or COVID-19 vaccines, on this trajectory and identify potential areas for interventions.

The PREMITUR study is a multi-site, prospective observational cohort study collecting maternal and infant biological samples at defined time points during pregnancy and post-partum. Currently 220 women are enrolled with nearly 1600 maternal and infant biospecimens collected across multiple sites in Australia and over 6000 samples stored in the biobank. The study is on track for its last year of recruitment and the study team is continuing to collect samples for future multi-omic applications.

The outcomes of the PREMITUR study are expected to identify critical areas for targeted intervention studies, significantly impacting maternal and child healthcare.

Collaborative support from RAN BIOLINKS team:

RAN BIOLINKS has been a key player in providing comprehensive support for the PREMITUR study, implementing advanced biobanking solutions, a seamless sample tracking system, and a comprehensive data monitoring platform. Our team remains committed to supporting the study team in further exciting multi-omic analyses, addressing data needs, and providing scientific support during and post-completion of the trial.

RAN BIOLINKS continues its commitment to contribute to healthcare evolution through innovative data management solutions.

For more information about the trial, check the latest publication from the team:
https://www.frontiersin.org/articles/10.3389/fimmu.2023.1212320/full

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Our Services Make A Difference, Hear It From Our Collaborators

"More than a Thousand households enrolled in record time and followed up throughout the study with home visits (in the midst of lockdowns) is what I would call LARGE SCALE!"

I know that most studies (even before the COVID, but especially during the pandemic) took years between starting and locking down data (and that is not taking into account the actual study duration). The operational infrastructure that you enabled for ConCorD19 was the first time that all of us PIs were part of a study that was implemented within weeks of design and data locked down within a few weeks of study end. This is unprecedented in my experience

- Prof. Tobias Kollmann
​Professor of System Vaccinology

"The day to day logistics of every aspect of the trial were managed, including procurement of the necessary biospecimen collection kits and transportation supplies"

Our COVID-19 clinical trial required coordination of field teams, timed biospecimen collection and the processing, storage and transportation of clinical samples (across international borders). The management of data that accrued in the trial database in real time ensured that the protocol was adhered to and provided the principle investigators tools to follow participant registration and biospecimen collection. In every regard, the operational needs of the trial were facilitated by RAN BioLinks. The day to day logistics of every aspect of the trial were managed, including procurement of the necessary biospecimen collection kits and transportation supplies, securing regulatory approvals for biospecimen transfers and coordinating border and customs requirements to expedite transfers. I look forward to working with RAN BioLinks in the future.

- Prof. Eleanore Fish
Professor & Associate Chair
Dept. Immunology, University of Toronto

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