Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000227392
Ethics application status
Approved
Date submitted
28/03/2008
Date registered
2/05/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bacille Calmette-Guérin (BCG) Immune Response Study
Scientific title
Improving protection against childhood tuberculosis: the influence of Bacille Calmette-Guérin (BCG) vaccine strain and age on protective immunity
Universal Trial Number (UTN)
Trial acronym
BIRS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 2972 0
Immune response after BCG vaccine 2973 0
Condition category
Condition code
Infection 3115 3115 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of three different BCG vaccine strains (BCG-Denmark, BCG-Japan, BCG-Russia) for immunisation at birth. Immunisation at 2 months of age with one BCG vaccine strain (BCG-Denmark). In all study groups 0.05ml of BCG will be administered intradermally.
Intervention code [1] 2711 0
Prevention
Comparator / control treatment
BCG vaccine strains will be compared with one another. Dose under 1 year of age 0.05 ml. Infants immunised at birth will be compared with those immunised at 2 months of age.
Control group
Active

Outcomes
Primary outcome [1] 4004 0
Frequency of cytokine (eg interferon-gamma) producing T cells measured by flow cytometry in samples after in vitro stimulation.
Timepoint [1] 4004 0
10 weeks after immunisation
Secondary outcome [1] 6742 0
Qualitative immune response measured as the pattern of cytokine producing T cells measured with flow cytometry and in supernatants using a multiplex bead array system.
Timepoint [1] 6742 0
10 weeks after immunisation

Eligibility
Key inclusion criteria
Term, well newborn infants.
Minimum age
1 Days
Maximum age
2 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Family history of immunodeficiencies. Mother with HIV. Mother with active TB.

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)
Consenting mothers/families in antenatal clinic. Randomisation of newborn infants to one of four groups at birth using seald opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using three broad ethnical groups: Parents originating form Africa, Indian Subcontinent, Asia.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
256
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3234 0
Government body
Name [1] 3234 0
Murdoch Children's Research Institute
Country [1] 3234 0
Australia
Funding source category [2] 3235 0
University
Name [2] 3235 0
Nossal Institute of Global Health
Country [2] 3235 0
Australia
Funding source category [3] 3236 0
Government body
Name [3] 3236 0
Swiss National Science Foundation
Country [3] 3236 0
Switzerland
Funding source category [4] 3237 0
University
Name [4] 3237 0
The University of Melbourne
Country [4] 3237 0
Australia
Funding source category [5] 3349 0
Charities/Societies/Foundations
Name [5] 3349 0
European Society for Paediatric Infectious Diseases
Country [5] 3349 0
Switzerland
Primary sponsor type
Hospital
Name
The Mercy Hospital for Women
Address
163 Studley Road, Heidelberg 3084, VIC
Country
Australia
Secondary sponsor category [1] 2895 0
None
Name [1] 2895 0
Address [1] 2895 0
Country [1] 2895 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5218 0
Human Research Ethics Committee, Mercy Hospital for Women
Ethics committee address [1] 5218 0
163 Studley Road, Heidelberg 3084, VIC
Ethics committee country [1] 5218 0
Australia
Date submitted for ethics approval [1] 5218 0
Approval date [1] 5218 0
07/12/2007
Ethics approval number [1] 5218 0
R07/16

Summary
Brief summary
This study is investigating the influence of vaccine strain and age at immunisation on the immune response in children to Bacille Calmette-Guérin (BCG) immunisation. The underlying hypothesis is that there is a measurable difference in the qualtitative and qualitative immune response which may be associated with differences in the level of protection
Trial website
Trial related presentations / publications
Ritz N, Hanekom, W, Robins-Browne R, Britton W, Curtis N. The influence of BCG vaccine strain on the immune response and protection against tuberculosis.
FEMS Microbiology Reviews 2008 in press.
Public notes

Contacts
Principal investigator
Name 28474 0
Address 28474 0
Country 28474 0
Phone 28474 0
Fax 28474 0
Email 28474 0
Contact person for public queries
Name 11631 0
Prof Nigel Curtis
Address 11631 0
Royal Children's Hospital Melbourne
Flemington Road
Parkville 3052, VIC
Country 11631 0
Australia
Phone 11631 0
03 9345 6366
Fax 11631 0
Email 11631 0
[email protected]
Contact person for scientific queries
Name 2559 0
Dr Nicole Ritz
Address 2559 0
Royal Children's Hospital Melbourne
Flemington Road
Parkville 3052, VIC
Country 2559 0
Australia
Phone 2559 0
03 9345 4990
Fax 2559 0
Email 2559 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseBacillus Calmette-Guerin Skin Reaction Predicts Enhanced Mycobacteria-Specific T-Cell Responses in Infants A Post Hoc Analysis of a Randomized Controlled Trial.2022https://dx.doi.org/10.1164/rccm.202108-1892OC
EmbaseMycobacterium ulcerans-specific immune response after immunisation with bacillus Calmette-Guerin (BCG) vaccine.2021https://dx.doi.org/10.1016/j.vaccine.2020.11.045
EmbaseComparable CD4 and CD8 T cell responses and cytokine release after at-birth and delayed BCG immunisation in infants born in Australia.2016https://dx.doi.org/10.1016/j.vaccine.2016.06.077
N.B. These documents automatically identified may not have been verified by the study sponsor.