None listed
Conditions
Brief summary
A multicentre clinical observational study to determine whether dysbiosis of the neonatal gut microbiome, driven by antibiotic exposure in the perinatal period, leads to impairment of subsequent antigen-specific responses to routine infant immunisations. This study will enrol vaginally born, term infants, with and without perinatal antibiotic exposure (maternal intrapartum antibiotics administered within 28 days of delivery or direct infant antibiotic exposure in the first 28 days of life. Infants will be vaccinated according to the National Immunisation Program and will have stool and blood samples collected to assess gut microbiome, gene expression responses and antigen specific vaccine responses. Proportions achieving seroprotective antibody titres at approximately 7 months and 18 months of age will be compared between exposed and unexposed groups to assess impact of early antibiotic exposure on subsequent vaccine responses.
Interventions
This is an observational trial which will examine and compare immune responses to vaccines in infants in three groups classified by exposure to antibiotics.
Group 1 –Infant with direct antibiotic exposure within 28 days of birth
Group 2 - Infant born to mother who received intrapartam maternal antibiotics within 28 days prior to delivery
Group 3 – Infant with no direct or maternal antibiotic exposure
Participants will be followed up from birth until 18 months of age.
Sponsors
Women's and Children's Health Network
Eligibility
Sex/Gender
All
Age
No minimum to 7 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy term infant (at least 37 weeks gestation) 2. Infant expected to have routine immunisation according to the National Immunisation Program (NIP) 3. Infant delivered vaginally
Exclusion criteria
1, Infant delivered by caesarean section 2. Infant has a confirmed sepsis (defined by laboratory confirmed bacterial infection in blood cultures or CSF) 3. Mother or infant has a known or suspected disorder of the immune system that would prevent an immune response to the vaccines, such as participant with congenital or acquired immunodeficiency or those receiving systemic immunosuppressive therapy. 4. Infant has suspected or confirmed HIV, major congenital abnormality or serious illness. 5. Mother or infant is participating in a clinical study that may interfere with participation in, or outcomes of this study 6.Mother of infant had a recorded Body Mass Index >30kg/m2 at a first trimester antenatal visit
Outcome results
None listed