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Published on: July 28, 2023
Consensus statement on diagnostic end points for infant tuberculosis vaccine trials.
Mark Hatherill1, Suzanne Verver, Hassan Mahomed
1South African Tuberculosis Vaccine Initiative, University of Cape Town, South Africa. mark.hatherill@uct.ac.za
Summary
Defining endpoints for childhood tuberculosis vaccine trials remains challenging. Experts reached modified consensus on some endpoints but lacked agreement on others, highlighting the need for a hierarchical approach.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Clinical trial methodology
Background:
- Lack of a standard case definition hinders clinical trial endpoint definition for childhood tuberculosis.
- Aims to identify consensus and debate on potential endpoints for tuberculosis vaccine trials in HIV-uninfected children.
Framework:
- Consensus Workshop involving 38 opinion leaders at the Second Global Forum on TB Vaccines.
- Outcomes categorized into unanimity, modified consensus, or lack of consensus, with individual reservations noted.
Implementation:
- Modified consensus on unsuitability of historical BCG trial endpoints, symptomatic intrathoracic tuberculosis, and primary complex tuberculosis in younger children.
- Agreement on hilar lymphadenopathy as primary radiologic diagnosis for intrathoracic tuberculosis.
- Lack of consensus on Mycobacterium tuberculosis culture significance and prior exposure evidence for diagnosis.
Implications:
- No single primary endpoint definition achieved; proposed hierarchy based on occurrence, relevance, and certainty.
- Identified criteria for composite or multiple endpoints for future tuberculosis vaccine trials.
- Highlights need for refined definitions considering disease phenotypes and diagnostic certainty in pediatric TB research.
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