None listed
Conditions
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.
Interventions
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: 2
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.
Sponsors
Monash Health
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
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.
Outcome results
None listed