Trial to Compare BCG-Bulgaria and BCG-Denmark
BCGSTRAIN IV
Randomized Trial Evaluating the Non-specific Effects of BCG-Bulgaria and BCG-Denmark in Guinea-Bissau: Effects on Mortality, Morbidity, and BCG Skin Reactions
1 other identifier
interventional
15,000
1 country
1
Brief Summary
The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of Hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare vaccination with Bacillus Calmette-Guérin (BCG) Danish strain (AJ Vaccines, Copenhagen 1331 strain) versus BCG-Bulgaria (BB-NCIPD, BCG-SL 222 Sofia strain) 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission. The trial will also examine the association between BCG strains and BCG skin reaction kinetics and characteristics. As a secondary aim, this large study will be used to further evaluate the role of maternal BCG immune priming for overall health, since there are indications that the maternal BCG scar status influences offspring health outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJanuary 22, 2024
January 1, 2024
1.7 years
May 24, 2022
January 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality risk
Deaths from all-causes
Six weeks of age
Secondary Outcomes (10)
All-cause mortality risk
One week of age
All-cause mortality risk
Six months of age
In-hospital case-fatality rate
Six weeks of age
In-hospital case-fatality rate
Six months of age
Hospital admission from all causes
Six weeks of age
- +5 more secondary outcomes
Study Arms (2)
BCG-Denmark
EXPERIMENTALInfants randomized to receive BCG-Denmark at discharge from the Maternity Ward will receive one 0.05 ml infant dose of Mycobacterium bovis BCG live-attenuated BCG-AJ vaccine by intradermal injection in the left deltoid region. Dependent on national supply, oral polio vaccine will be co-administered.
BCG-Bulgaria
ACTIVE COMPARATORInfants randomized to receive BCG-Bulgaria at discharge from the Maternity Ward will receive one 0.05 ml infant dose of Mycobacterium bovis BCG live-attenuated BCG-Bulgaria vaccine by intradermal injection in the left deltoid region. Dependent on national supply, oral polio vaccine will be co-administered.
Interventions
Eligibility Criteria
You may qualify if:
- \- Healthy infants under one year of age who are vaccinated at the HNSM maternity ward.
You may not qualify if:
- Infants who have already received either BCG or oral polio vaccine (OPV)
- Infants who are moribund due to gross malformation or acute illness (about to die or be transferred to the pediatric ward according to the local health physician assessment); the latter children can be recruited when they are discharged from the pediatric ward or the neonatal intensive care unit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bandim Health Projectlead
- University of Southern Denmarkcollaborator
Study Sites (1)
Bandim Health Project
Bissau, Guinea-Bissau
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Aaby, Professor
Bandim Health Project
- STUDY CHAIR
Christine Stabell Benn, Professor
University of Southern Denmark and Bandim Health Project
- STUDY DIRECTOR
Frederik Schaltz-Buchholzer, MD, PhD
University of Southern Denmark and Bandim Health Project
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Following informed consent, the child's mother/guardian selects, from a stack of envelopes, a closed envelope that contains a sealed randomization lot indicating allocation to either BCG-Denmark or BCG-Bulgaria. The mother, inclusion assistant and vaccinator will thus not be blinded to the intervention allocation. All assistants assessing outcomes during follow-up procedures and providers of care will be blinded to the randomization allocation.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
May 31, 2022
Study Start
October 21, 2022
Primary Completion
July 1, 2024
Study Completion
October 1, 2024
Last Updated
January 22, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share
Deidentified participant data with a data dictionary can be shared after approval of a data-sharing proposal sent to Professor Christine Stabell Benn (cbenn@health.sdu.dk).