drugset / Trial / NCT01906853
Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction
Phase 3
Completed
1272 enrolled
Murdoch Childrens Research Institute
Mercy Hospital for Women, Australia · collabRoyal Children's Hospital · collabUniversity of Melbourne · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
1. To determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life. 2. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.
Timeline
- Start
- 2013-07
- Primary completion
- 2023-09
- Completion
- 2025-02
Outcome
Missed primary endpoint
paper adjusted risk difference (aRD) 3.8% (95% CI -1.5 to 9.1) after multiple imputation). PMID 39004434 ↗
paper Neonatal BCG-Denmark vaccination does not protect against atopic sensitisation or clinical food allergy in the first year of life. PMID 39004434 ↗
paper adjusted risk difference (aRD) -4.3%, 95% CI -9.9% to 1.3%, multiple imputation model). PMID 34309859 ↗
paper adjusted risk difference [aRD] -1.7 percentage points; 95%CI -7.4, 3.9. PMID 40464744 ↗
Publications
- Khazaei Y, Kodikara S, Butler CA, Messina NL, Le Cao KA, Dashper SG, Silva MJ. Development and validation of diagnostic and prognostic prediction tools for dental caries in young children through prospective and cross-sectional observational studies: a protocol. BMJ Open. 2025 Oct 5;15(10):e105145. doi: 10.1136/bmjopen-2025-105145.
- Pittet LF, Forbes EK, Donath S, Francis KL, Gardiner K, Flanagan KL, Ponsonby AL, Robins-Browne R, Shann F, South M, Vuillermin P, Casalaz D, Curtis N, Messina NL; Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group. Neonatal BCG vaccination to prevent asthma: Results from the MIS BAIR randomized controlled trial. Pediatr Allergy Immunol. 2025 Jun;36(6):e70110. doi: 10.1111/pai.70110.
- Messina NL, Gardiner K, Pittet LF, Forbes EK, Francis KL, Freyne B, Zufferey C, Abruzzo V, Morison C, Turner H, Allen KJ, Flanagan KL, Ponsonby AL, Robins-Browne R, Shann F, Vuillermin P, Donath S, Casalaz D, Curtis N; Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) Group. Neonatal BCG Vaccination for Prevention of Allergy in Infants: The MIS BAIR Randomised Controlled Trial. Clin Exp Allergy. 2024 Sep;54(9):682-693. doi: 10.1111/cea.14537. Epub 2024 Jul 14.
- Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Morrison C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Donath S, Casalaz D, Phillips R, Curtis N. Discordance Between Diagnosis Tools for Assessing Eczema in Infants: A Challenge for Intervention Trials. Dermatitis. 2022 May-Jun 01;33(3):207-214. doi: 10.1097/DER.0000000000000842. Epub 2022 Feb 16.
- Pittet LF, Messina NL, Gardiner K, Freyne B, Abruzzo V, Francis KL, Morrison C, Zufferey C, Vuillermin P, Allen KJ, Ponsonby AL, Robins-Browne R, Shann F, Flanagan KL, Phillips R, Donath S, Casalaz D, Curtis N. Prevention of infant eczema by neonatal Bacillus Calmette-Guerin vaccination: The MIS BAIR randomized controlled trial. Allergy. 2022 Mar;77(3):956-965. doi: 10.1111/all.15022. Epub 2021 Aug 9.
- Cirovic B, de Bree LCJ, Groh L, Blok BA, Chan J, van der Velden WJFM, Bremmers MEJ, van Crevel R, Handler K, Picelli S, Schulte-Schrepping J, Klee K, Oosting M, Koeken VACM, van Ingen J, Li Y, Benn CS, Schultze JL, Joosten LAB, Curtis N, Netea MG, Schlitzer A. BCG Vaccination in Humans Elicits Trained Immunity via the Hematopoietic Progenitor Compartment. Cell Host Microbe. 2020 Aug 12;28(2):322-334.e5. doi: 10.1016/j.chom.2020.05.014. Epub 2020 Jun 15.
- Messina NL, Gardiner K, Donath S, Flanagan K, Ponsonby AL, Shann F, Robins-Browne R, Freyne B, Abruzzo V, Morison C, Cox L, Germano S, Zufferey C, Zimmermann P, Allen KJ, Vuillermin P, South M, Casalaz D, Curtis N. Study protocol for the Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR), a randomised controlled trial to determine the non-specific effects of neonatal BCG vaccination in a low-mortality setting. BMJ Open. 2019 Dec 15;9(12):e032844. doi: 10.1136/bmjopen-2019-032844.
- Zimmermann P, Perrett KP, van der Klis FR, Curtis N. The immunomodulatory effects of measles-mumps-rubella vaccination on persistence of heterologous vaccine responses. Immunol Cell Biol. 2019 Jul;97(6):577-585. doi: 10.1111/imcb.12246. Epub 2019 Mar 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG Denmark | Vaccine | 0.05 ml | Other |