Tuberculosis Vaccine Preparedness Repository

About

Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) is a five-year cooperative agreement made possible by the United States Agency for International Development (USAID), with the assistance of the American people, that aims to transform TB prevention and care. Vaccine Preparedness is one of SMART4TB’s focus areas and this platform showcases completed, ongoing, and planned TB vaccine preparedness projects to foster collaboration among the many actors in this space. To learn more about our methodology for the repository, visit the Overview section.

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Projects and Initiatives

Mapping the existing body of knowledge on new and repurposed TB vaccine implementation: A scoping review

By synthesizing the existing body of knowledge, this review offers comprehensive insights into the current state of research on implementation of these TB adults and adolescent vaccines. Offering insights into key dimensions: (1) epidemiological impact, (2) costing, cost-effectiveness, and/or economic impact, (3) acceptability, and the (4) feasibility of implementation; this includes implementation strategies of target populations, and health system capabilities.

What do people want?

Investigate current TB prevention modalities vs vaccine. We lack understanding of preferences and trade offs people would be willing to make across a spectrum of issues related to study design, type of vaccines, how they are given, how often, where they are given, to whom, efficacy estimates and side effects etc.

TPTVaxx

Vaccines will be introduced in contexts where TPT already exists. Exploration of possible study designs, expected effectiveness, feasibility of integrated approaches is key.

Evidence considerations for vaccine policy development for tuberculosis vaccines intended for adults and adolescents

The ECVP facilitates early engagement and alignment across the stakeholders involved in vaccine development and those responsible for vaccine regulatory, policy, funding and country introduction decisions. This framework aims to anticipate and collectively delineate the clinical trial, observational, and other data likely to be required by global and national policymakers, and to do so when most valuable – during development of the late-stage clinical plan, including the design of the pivotal licensure trial.

A global framework to prepare for country introduction of new TB vaccines for adults and adolescents

New vaccines for the prevention of TB disease in adolescents and adults could become available in the next 3-5 years. WHO has therefore developed a Global Framework to prepare for Country Introduction of New TB Vaccines for Adults and Adolescents which aims to guide countries and global stakeholders in preparing for the introduction and scale-up in countries. This framework has been drafted in collaboration with a WHO Expert Advisory Group and in consultation with other stakeholders, and describes critical activities to prepare for introduction decision-making and subsequent implementation and impact of new TB vaccines for adults and adolescents. 

Preferred product characteristics for new tuberculosis vaccine

The document presents WHO preferences for new tuberculosis vaccines, driven by the high medical need for contribution to the fight against TB, in alignment with the End TB strategy. Priorities are for a vaccine to be administered to adolescents and adults for prevention of pulmonary tuberculosis and reduction of transmission, and for a pediatric vaccine with improved safety and efficacy as compared to BCG.

Preferred product characteristics for therapeutic vaccines to improve tuberculosis treatment outcomes

The preferred product characteristics (PPC) for therapeutic TB vaccines described in this document are intended to provide guidance to scientists, funding agencies, public and private sector organizations developing such vaccine candidates. This document presents potential clinical end-points for ev idence generation and discusses key considerations about potential clinical development strategies

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