Summary: 2025 Working Group on New TB Vaccines Annual Open Meeting

By: WGNV

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The Stop TB Partnership Working Group on New TB Vaccines (WGNV) held its 3rd Annual Open Meeting on 17 November 2025 in Copenhagen, Denmark, in advance of the Union World Conference on Lung Health. The meeting was part of “Innovate, Integrate, Impact: A symposium on New Tools to End TB”, organized by the Stop TB Partnership, the Working Groups on New Drugs, the New Diagnostics Working Group, FIND, and the Novo Nordisk Foundation Initiative for Vaccines and Immunity (NIVI). Our thanks to the presenters and all the participants for your interest in WGNV and what is happening in the field.

The agenda included an overview of WGNV activities, brief updates on global and collaborative initiatives in TB vaccine research, development and implementation, reviews of progress and opportunities in early-stage, preclinical and clinical research, and a panel discussion on perspectives on engaging and preparing communities for new TB vaccines.

View the agenda for the WGNV meeting here.
View the agenda for the full symposium here.

Welcome and Update on Activities

WGNV Chair David Lewinsohn opened the session and welcomed participants. Jennifer Woolley, WGNV Secretariat, provided an overview of WGNV activities in its priority areas of knowledge-sharing, fostering discussion and collaborationadvocacy, and issues in product development. Rebecca Clark, a member of the WGNV Early Career Researcher Network Steering Committee, provided an overview of Network activities.

Participants were encouraged to get involved by joining WGNV, participating in the newly launched WGNV Online Community, engaging in WGNV activities, and leveraging the resources and information available through the WGNV website and other platforms.

 Slides | Video

Global and Collaborative Initiatives in TB Vaccine, Research, Development, and Implementation

Speakers in this session presented brief updates on global and collaborative efforts underway to support and advance TB vaccine research, development, and implementation.

  • Rasmus Mortensen (Statens Serum Institut) provided an overview of the Novo Nordisk Foundation Initiative for Vaccine and Immunity (NIVI), which has the two-pronged mission of 1) generating knowledge on host immunity, host-pathogen interactions, and vaccine technologies; and 2) translating knowledge into vaccines that provide robust, durable, and broad immunity against respiratory pathogens, including tuberculosis.
  • Elly van Riet (TBVI) reviewed the TB Vaccine Product Development Pathway, an online tool to help researchers navigate the path from discovery to a tangible product. She gave an overview of the Pathway, it’s role in the end-to-end approach of TB vaccine development, opportunities for researchers to get support in product development, and updates and revisions currently underway.
  • Frank Cobelens (AIGHD) summarized the findings of a review being conducted on progress against key targets in the TB Vaccine Roadmap launched five years ago. He noted what has been achieved and what is still outstanding under each of the five themes of the Roadmap – basic and translational science, animal models, clinical trials, epidemiology and modelling, and research to ensure optimal implementation.
  • Birgitte Giersing (WHO) shared updates on the work of the TB Vaccine Accelerator Council, including recent interactions with and initial feedback from the WHO Strategic Advisory Group of Experts (SAGE) ; and updates on activities related to three of the working groups established under the Accelerator – WG 2: Product development, manufacturing & policy (see  here for the WHO technical advisory group on clinical and policy); WG 3: Finance & Access; and WG4: Country Readiness, Advocacy, and Community Partnership.
  • Shaun Palmer (IAVI) discussed a series of workshops exploring opportunities for innovative and long-term sustained funding for TB vaccine R&D and for product development at large. Key themes emerging from these discussions include enhancing the role of high-burden middle-income countries in vaccine financing, diversifying funders and coordinating resources, and supporting a whole-system approach to enhance broader regional health R&D infrastructure and capabilities.

Slides | Video

Opportunities in Clinical and Preclinical Research

This session focused on key issues and opportunities to expand and enhance clinical and preclinical research.

Elana van Brakel (IAVI) gave a high-level overview of current considerations in TB vaccine clinical trials, with an emphasis on faster, smarter clinical development. Her talk focused on target populations, with prevention of clinical TB in adolescents and adults having the greatest impact; trial endpoints, primarily prevention of symptomatic disease, as well as recent discussion on using asymptomatic TB as an endpoint; Mtb sensitization status (IGRA+/IGRA-); and including people living with HIV and pregnant and lactating women.

David Lewinsohn (Oregon Health & Science University) discussed new research underway in the early-stage and preclinical area. With regard to antigens, he discussed the importance of understanding the context, that is, which antigens are presented on the Mtb-infected cell, and the identity and location of the cells presenting these antigens. He presented research on two RNA vaccines that both show preclinical efficacy, and for which one (Biontech) has advanced to human evaluation. He presented work on the development of new adjuvants. Two models were discussed that might inform the development of vaccines that can address key issues in the human response to exposure to Mtb, specifically the potential to clear the infection following challenge:  The first the low-dose challenge mouse model, and the second the human challenge model (also known as the controlled human infection model). He argued that, to accelerate TB vaccine R&D, it is imperative to conduct experimental medicine studies to determine what a vaccine can do before it enters late-stage trials and emphasized the need for the will and resources to fund such studies in the early stages of a vaccine.

Slides | Video

Perspectives on Engaging and Preparing Communities for New TB Vaccines

The meeting concluded with a panel session on engaging and preparing communities for new TB vaccines. Mike Frick (Treatment Action Group) moderated the discussion, and Priyanka Aiyer (Global Fund Advocates Network), Peter Owiti (Gavi CSO Constituency Steering Committee and WGNV Core Group), and Limakatso Lebina (Africa Health Research Institute provided their perspectives as panelists. They explored numerous topics, including what we need to be doing with communities now, while the science is still underway, to prepare for efficacy results and vaccine roll-out; issues that are being discussed in South Africa, as one of the countries taking a leading role in preparing for the roll-out of new TB vaccines; how to get global structures organized to figure out the supply, access, and financing components in making new TB vaccines available; practical examples of pitfalls to avoid from learned experiences with existing vaccine introductions; and the contributions and unique role that civil society and communities can play in preparing for new TB vaccines.

Video

Full videos of all symposium sessions can be found here.

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