Bacterial mucosal immunotherapy for prevention of lower respiratory tract infections in preterm born infants

Infants born <30 weeks’ gestation often develop lung disease during the neonatal period, putting them at risk of significant lung disease throughout child- and adulthood, including asthma and the premature development of chronic obstructive pulmonary disease. After discharge from the neonatal unit, lung disease is exacerbated by frequent respiratory viral infections requiring far greater health utilisation than their term-born equivalents. Even in term-born infants, viral infections are associated with the development of preschool wheezing and lifelong chronic lung disease. However, the consequences are more severe in preterm-born infants due to these added insults on the background of significant pre-existing lung disease. Trained immunity-based vaccines, such as Bactek (MV-130) are increasingly used to prevent viral infections in young children susceptible to developing persistent wheeze; providing protection via activation of innate and adaptive immunity. The Primary Objective of the BALLOON Trial is to investigate if sublingual Bactek, compared to placebo, decreases health professional confirmed lower respiratory tract infections (LRTIs) and associated healthcare utilisation in infants born <30 weeks' gestation, between randomisation and one year corrected age. Secondary Objectives are to establish if sublingual Bactek is superior to placebo to:

(1) reduce parent-reported, health professional confirmed wheezing;

(2) reduce respiratory medication usage including inhalers, antibiotics and systemic corticosteroids, and

(3) reduce the economic and family burden of LRTIs.

Mechanistic Objectives, include assessing the effect of Bactek on"

(1) lung function trajectory;

(2) the infants’ adaptive immunity and its modulation;

(3) establish which respiratory viruses associated with LRTIs are modulated by treatment, and

(4) trained immunity in vivo in circulating myeloid cells.

This intervention may improve the lifelong lung health trajectories for survivors of preterm birth.

If you are interested, please contact Dr Tamara Blake for further information.