Tuberculosis vaccines
IVR's role and related links
IVR's role in TB vaccine development
The WHO Initiative for Vaccine Research (IVR) actively facilitates TB vaccine development with the overriding objective to accelerate the availability of a safe, effective, appropriate and affordable vaccine. In particular, IVR
In particular, IVR:
- helps to build international consensus on:
- harmonization of laboratory assays that can be used to evaluate the immunogenicity, safety and parameters such as vaccine "take" of a TB vaccine candidate
- definition of the quality and magnitude of clinical signs and symptoms, so-called clinical endpoints, used to determine the clinical efficacy of a new TB vaccine
- clinical and physical standards for vaccine evaluation and quality control
- clinical trial design, clinical development plans and regulatory pathways, and
- target product profiles
- builds the capacity of regulatory agencies in disease-endemic countries to evaluate TB vaccine-related submission for clinical studies and licensure;
- supports TB high burden countries to define a national strategy for the evaluation of, and access to new TB vaccines;
- assures that TB vaccine clinical trials collect all the information necessary for a future WHO policy recommendation; and
- provides the secretariat function for the Vaccine Working Group of the Global Partnership to Stop TB.
WHO guidelines on tuberculosis
- Immunological basis for immunization series module 5: tuberculosis (2011)
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WHO position paper on BCG vaccine (2004)
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