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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001111369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
22/12/2025
Date registered
Help: Date registered
8/09/2026
Date last updated
Help: Date last updated
8/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
8/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Bacterial mucosal immunotherapy for prevention of lower respiratory tract infections in preterm born infants- AUSTRALIA (BALLOON-AU)
Scientific title
Bacterial mucosal immunotherapy for prevention of lower respiratory tract infections in preterm born infants- AUSTRALIA (BALLOON-AU)
Additional trial identifiers [1] 316188 0
none
Universal Trial Number (UTN)
Trial acronym
BALLOON-AU
Related trial records

Health condition
Health condition(s) studied:
Lower Respiratory Tract Infections 340250 0
Condition category
Condition code
Respiratory 336444 336444 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 332870 0
Treatment: Drugs
Description of the comparator or control
Placebo: A sublingual spray comprising of all excipients of the MV130, aside from the inactivated bacteria. The placebo and study treatment are both manufactured by Inmunotek, Spain to ensure true blinding. The trial will be carried out under a Clinical Trial Notification submitted to the Therapeutic Goods Administration. The intervention is therefore only to be used by the named investigators, for the participants specified in this protocol, and within the trial.
Control group
Placebo

Outcomes
Primary outcome [1] 343964 0
The primary outcome: To investigate if sublingual Bactek spray, when compared to placebo, decreases the risk of health professional confirmed LRTIs and associated healthcare utilisation in infants born <30 weeks’ gestation, between randomisation and one year of corrected age.
Timepoint [1] 343964 0
LRTI events will be monitored continuously from randomisation to 12 months corrected age, with data collected through weekly parent questionnaires, scheduled telephone follow-up calls, and in-person clinic assessments at 3, 6, 9, and 12 months corrected age.
Secondary outcome [1] 456259 0
Number of health professional–diagnosed lower respiratory tract infection (LRTI) episodes.
Timepoint [1] 456259 0
Continuously between randomisation and 12 months corrected age, with assessment at 3, 6, 9, and 12 month clinic visits.
Secondary outcome [2] 458869 0
Time to first health professional–diagnosed lower respiratory tract infection (LRTI).
Timepoint [2] 458869 0
Measured from randomisation until the first LRTI event or until 12 months corrected age.
Secondary outcome [3] 458870 0
Number of parent-reported, health professional-confirmed wheezing episodes.
Timepoint [3] 458870 0
Assessed continuously between randomisation and 12 months corrected age, with reporting at scheduled follow-up contacts and clinic visits.
Secondary outcome [4] 458871 0
Respiratory viruses detected during health professional-confirmed LRTI episodes.
Timepoint [4] 458871 0
At each qualifying LRTI episode between randomisation and 12 months corrected age.
Secondary outcome [5] 458872 0
Respiratory medication use.
Timepoint [5] 458872 0
Assessed continuously between randomisation and 12 months corrected age, with reporting at 3, 6, 9 and 12 month clinic visits.
Secondary outcome [6] 458873 0
Impact of LRTI on the infant and family, including days of childcare and work missed.
Timepoint [6] 458873 0
Continuously from randomisation to 12 months corrected age through weekly REDCap questionnaires, with additional assessment using the Health Economics Questionnaire at 6 and 12 months corrected age.
Secondary outcome [7] 458874 0
Safety of MV130 (Bactek) administration in preterm infants, measured by adverse events.
Timepoint [7] 458874 0
Continuously from randomisation throughout the 12-month treatment period and at the Month 13 safety follow-up.
Secondary outcome [8] 465887 0
Health-related quality of life of infants and their carers.
Timepoint [8] 465887 0
Approximately 2 weeks following neonatal discharge, and at 6 and 12 months corrected age.
Secondary outcome [9] 465888 0
Lung function trajectory.
Timepoint [9] 465888 0
At randomisation, and at 6 and 12 months corrected age.
Secondary outcome [10] 465889 0
Somatic growth, assessed by weight, length and head circumference.
Timepoint [10] 465889 0
At baseline and at 3, 6, 9 and 12 months corrected age.
Secondary outcome [11] 467024 0
To assess the immunological effects of Bactek treatment, including adaptive and trained immunity.
Timepoint [11] 467024 0
Baseline

Eligibility
Key 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
Minimum age
No limit
Maximum age
37 Weeks
Sex
Both males and females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation program was developed by the Centre for Trials Research (CTR) BALLOON trial team at Cardiff University, UK (international trial lead) and will be embedded within the study database with controlled access maintaining blinding. Online randomisation is through the central BALLOON Trial Randomisation Database provided by The Centre for Healthcare Randomised Trials (CHaRT). Access to the randomisation allocation will be strictly controlled.
Site randomisation will occur centrally by BALLOON trial team at Cardiff University, UK). At randomisation, an authorised member of the site research team (site neonatologist, neonatal research nurse or dispensing pharmacist at neonatal unit) will access the central BALLOON Trial Randomisation Database. After confirming that the participant qualifies for randomisation, the randomisation system will assign both a study ID and a treatment pack ID number. The treatment pack ID links the participant to a unique treatment pack of the trial drug to be allocated. An automated email confirming the randomisation will be sent to the site team and a copy of the email will also be sent to the local site pharmacy team and to the BALLOON-UK trial team. To avoid any issues with inadvertent unblinding or dosing errors, multiple births will be randomised to the same arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 using minimisation with a random element (p = 0.8). Allocations will be minimised by gestational age and anti-RSV prophylaxis – both assumed to have a strong prognostic relationship with the outcome. The randomisation program was developed by the Centre for Trials Research (CTR) BALLOON trial team at Cardiff University, UK (international trial lead) and will be embedded within the study database with controlled access maintaining blinding. Online randomisation is through the central BALLOON Trial Randomisation Database provided by The Centre for Healthcare Randomised Trials (CHaRT). Access to the randomisation allocation will be strictly controlled.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis
The primary analysis will compare the proportion of participants receiving a health professional diagnosed LRTI post-randomisation between randomisation and one-year corrected age between arms by fitting a two-level Poisson (or negative binomial) regression model, with participants nested within centres. Models will also adjust for gestation at birth and anti-RSV prophylaxis (as per randomisation factors). Results will be reported as risk ratios, 95% confidence intervals, and p-values. Missing data will be managed within a multiple imputation framework. Sensitivity analyses will consider (i) a comparison between arms of the number of health professional diagnosed LRTI episodes within 12-months, and (ii) the use of inverse probability of treatment weights to estimate the effect of the intervention under the hypothetic scenario of different levels of adherence. The primary analyses will examine subgroup interaction terms to explore any differential intervention effects by gestational age, anti-RSV prophylaxis, and centre.
Secondary outcomes will be analysed using appropriate regression models (e.g., linear, Poisson, negative binomial, flexible parametric survival models), adjusting for stratification and minimisation variables as per the primary analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/01/2029
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
Recruitment outside Australia
Country [1] 27720 0
United Kingdom
State/province [1] 27720 0

Funding & Sponsors
Funding source category [1] 320785 0
Government body
Name [1] 320785 0
Australian Government Department of Health, Disability and Ageing – Medical Research Future Fund (MRFF), 2024 International Clinical Trial Collaborations
Country [1] 320785 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Kids Research Institute Australia
Address
Country
Australia
Secondary sponsor category [1] 324089 0
None
Name [1] 324089 0
Address [1] 324089 0
Country [1] 324089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319316 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 319316 0
Ethics committee country [1] 319316 0
Australia
Date submitted for ethics approval [1] 319316 0
22/09/2025
Approval date [1] 319316 0
08/12/2025
Ethics approval number [1] 319316 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 146958 0
A/Prof Shannon Simpson
Address 146958 0
The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands, WA, 6009
Country 146958 0
Australia
Phone 146958 0
+61 0400848313
Fax 146958 0
Email 146958 0
[email protected]
Contact person for public queries
Name 146959 0
Shannon Simpson
Address 146959 0
The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands, WA, 6009
Country 146959 0
Australia
Phone 146959 0
+61 0400848313
Fax 146959 0
Email 146959 0
[email protected]
Contact person for scientific queries
Name 146960 0
Shannon Simpson
Address 146960 0
The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands, WA, 6009
Country 146960 0
Australia
Phone 146960 0
+61 8 6319 1000
Fax 146960 0
Email 146960 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.