None listed
Conditions
Brief summary
Preterm infants born <30 weeks’ gestation are at increased risk from additional damage to their already impaired lungs through Lower Respiratory Tract Infections over their first year of life. Data supports the use of trained immunity vaccines to reduce rates of Lower Respiratory Tract Infections and wheeze/asthma in the at risk populations, which include small numbers of preterm infants, not currently separately analyzed. This study aims to apply this potentially effective treatment specifically to a very preterm population. It is hypothesized that treatment with Bactek in the first year of life will reduce Lower Respiratory Tract Infections and Lower Respiratory Tract Infection associated healthcare utilization in infants born very preterm.
Interventions
Bactek (MV130, Inmunotek, Spain)
MV130 is a mucosal bacterial immunotherapy (under the brand name of BACTEK® or Bacmune®), containing as active ingredient/s different species of whole inactivated and selected non-lysate bacterial concentrates at 300 FTU which are frequently present in the respiratory tract. MV130 contains whole cell heat inactivated: Staphylococcus aureus, strain V102 (15%), Staphylococcus epidermidis, strain V101 (15%), Streptococcus pneumoniae, strain V104 (60%), Klebsiella p
Bactek (MV130, Inmunotek, Spain) MV130 is a mucosal bacterial immunotherapy (under the brand name of BACTEK® or Bacmune®), containing as active ingredient/s different species of whole inactivated and selected non-lysate bacterial concentrates at 300 FTU which are frequently present in the respiratory tract. MV130 contains whole cell heat inactivated: Staphylococcus aureus, strain V102 (15%), Staphylococcus epidermidis, strain V101 (15%), Streptococcus pneumoniae, strain V104 (60%), Klebsiella pneumoniae, strain V113 (4%), Moraxella catarrhalis, strain V105 (3%) and Haemophilus influenzae, strain V103 (3%). MV130 will be administered once daily. The recommended dose is 2 sublingual sprays per day in a single procedure (one dose is 2 sprays), for a final daily dose of approximately 0.2 mL according to the study protocol. MV130 is administered sublingually by the patient following these instructions: o Remove the plastic seal from one bottle. o Gently shake the bottle. o Rotate the nozzle sideways. Spray 3 or 4 times to ensure the pump mechanism fills up (only when starting the bottle). o Lift the tongue, directing the nozzle under the tongue and spray twice to apply the appropriate dose. o Retain the dose beneath the tongue, without swallowing for approximately 1-2 minutes before swallowing. o Rotate the nozzle back to its original vertical position, thereby locking the spray mechanism. o Return the bottle back to the box and store accordingly. When the first bottle is finished, continue with the second one with the same dose (2 sprays daily). The duration of each bottle is approximately 45 days at the recommended dose. The total duration of the intervention is 12 months. Participants will therefore receive multiple bottles throughout the study period. Participants will attend follow-up study visits at 3, 6, 9, and 12 months for medical review and medication dispensing/medication compliance check (except at month 12 as no medication will be dispensed at this visit). Compliance will be assessed by return of study bottles at each 3-monthly visit and evaluation of the number of actuations remaining.
Sponsors
The Kids Research Institute Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 37 Weeks
Healthy volunteers
No
Inclusion criteria
Participant inclusion criteria. • Infants born at <30 weeks’ gestational age and recruited before 37 weeks’ post-menstrual age • Survival to 1-year (corrected for prematurity) is anticipated, as determined by care team • Willingness to adhere to the study protocol and attend the required follow-up visits
Exclusion criteria
Participant exclusion criteria. • Presence of significant cardiovascular (but not patent ductus arteriosus or patent foramen ovale), surgical or congenital anomalies • Contraindication of Bactek™ as specified in the Investigator’s Brochure • Primary immune deficiencies • Enrolled in other contradictory/non-complimentary intervention trials or in state care
Outcome results
None listed