The Stop TB Partnership Working Group on New TB Vaccines (WGNV) held its second annual meeting on 12 November 2024 in Bali, Indonesia. The meeting was part of the full-day New TB Tools Summit 2024 – a collaboration between WGNV, the Stop TB Partnership’s Working Group on New Drugs and New Diagnostics Working Group, and FIND – held just in advance of the 54th Union World Conference on Lung Health. 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 update on WGNV activities, key outcomes from the 7th Global Forum on TB Vaccines, updates on two vaccine candidates in Phase 3 development (M72 and MTBVAC), a read-out from a policy and planning meeting for implementation of new TB vaccines in Indonesia, and a presentation on the importance of community engagement in TB vaccine research, development, and implementation. View the full agenda here.
WGNV Update
WGNV Chair David Lewinsohn opened the session and welcomed participants. Jennifer Woolley, Head of the WGNV Secretariat, provided an overview of WGNV overarching accomplishments and activities over the past year as well as accomplishments and activities in theWGNV priority areas of knowledge-sharing, fostering discussion and collaboration, advocacy, and issues in product development. Carly Young, Co-Chair of the WGNV Early Career Researcher Network Steering Committee, provided an overview of Network activities. Jennifer and Carly also shared a preview of what is planned for 2025.
Shaun Palmer, Coordinator of the TB Vaccine Advocacy Roadmap (TB Vax ARM), provided an overview of TB Vax ARM (for which WGNV is a Core Group member), its approach, priority areas, and key activities.
Participants were encouraged to get involved by joining WGNV and TB Vax ARM, participating in WGNV and TB Vax ARM activities, sharing information and resources that WGNV can post on its website, and to suggest topics or activities that WGNV can facilitate to benefit the TB vaccine R&D community.
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Key Outcomes from the 7th Global Forum on TB Vaccines
The next portion of the meeting focused on key outcomes from the 7th Global Forum on TB Vaccines (7GF) which took place from 8 – 10 October 2024 in Rio de Janeiro, Brazil.
David Lewinsohn (7GF Co-Chair, Oregon Health & Science University) reviewed key outcomes for the thematic track on Diversifying the TB Vaccine Pipeline, including efforts to develop biomarkers, correlates of protection, and measure of bacterial burden; increasing diversity through novel approaches and platforms; optimizing animal models to better reflect human disease; and progress and lessons learned in the development a controlled human infection model (also known as a human challenge model).
Ann Ginsberg (7GF Organizing Committee, Gates Foundation) summarized key takeaways related to clinical development of new TB vaccines based on three key themes that emerged as enabling factors throughout 7GF: 1) the need for more funding, including a more diverse donor base, innovative funding solutions and new partnerships to provide sufficient funding to ensure a robust pipeline and advance candidates through the clinic; 2) innovative approaches to make clinical trials and the road to licensure faster and less expensive; and 3) that collaboration is crucial to fill the funding gap, pool experience, and identify innovative ways to advance the most promising vaccine candidates as quickly and efficiently as possible.
Richard White (7GF Organizing Committee, London School of Hygiene & Tropical Medicine) reviewed key topics discussed at 7GF in the tracks on Ensuring Public Health Impact and Implementation of new TB Vaccines. His key takeaways focused on impressive country preparedness underway, first data on new TB vaccine acceptability, and new and useful modelling/framework activities (for example, allocation frameworks and impact models).
Shaun Palmer (7GF Community Engagement Committee, IAVI) gave an overview of community engagement and advocacy activities in the lead up to and during 7GF, led by the first-ever Global Forum Community Engagement Committee. The Committee led the development of the 7th Global Forum Community Declaration through a consultative process, which garnered 1410 individual and organizational signatories from 81 countries, and they helped to ensure active, meaningful visibility of communities throughout 7GF.
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Updates on the MTBVAC and M72/AS01E Vaccine Candidates
This section of the agenda gave an overview of two candidates in Phase 3 clinical development: M72/AS01Eand MTBVAC (representatives for other candidates in Phase 3 trials were invited but not able to participate in this session).
Ann Ginsberg introduced the session and provided context on how these candidates fit in the overall TB vaccine portfolio. Her presentation included a review of the WHO Preferred Product Characteristics for New TB Vaccines and a brief overview of TB vaccines in Phase 3 development. She also emphasized the importance of the unprecedented number of efficacy trial results that will be available over the next five years and what the field will be able to learn from these trials to advance TB vaccine research and development (R&D).
Mark Hatherill (South African Tuberculosis Vaccine Initiative, University of Cape Town) gave an overview ofthe MTBVAC candidate, including a description of the candidate, the clinical trial history, noting that the candidate is following two development pathways – in infants and in adolescents and adults – and ongoing trials and plans for further clinical development of the candidate.
Alemnew Dagnew (Bill & Melinda Gates Medical Research Institute) presented an update on the M72/AS01E candidate, including the product development background, a description of the candidate, clinical development of the candidate including completed and ongoing trials, the proposed indication for the vaccine, and progress in the ongoing Phase 3 trial.
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Preparing for Implementation
Birgitte Giersing (WHO) gave a report from a meeting held on 8 – 9 November on “New TB Vaccines & Indonesia: Policy Planning and Evidence”. This was the first country-specific consultation on TB vaccine implementation, which is important in understanding the context and country-specific situation that will vary among high burden countries. She reviewed the objectives of the meeting, country-specific criteria for vaccine introduction, the TB context in Indonesia, the process and content of the meeting, and the meeting conclusions and recommendations based on the goals of Available, Accessible, and Accepted as outlined in the WHO global framework to prepare for country introduction of new tuberculosis vaccines for adolescents and adults. A report from this meeting is being prepared for publication.
Community Engagement
The final presentation, given by Peter Owiti (WGNV Core Group, Gavi CSO Steering Committee, Stop TB Partnership Affected Communities Delegation) focused on the importance of meaningful community engagement in TB vaccine research, development, and deployment. He stressed why community engagement is imperative and non-negotiable for vaccine success, reviewed the roles of the Gavi Civil Society Steering Committee, international organizations like Gavi, UNICEF, Global Fund and World Bank, and communities and stressed the importance of collaboration. He also discussed community expectations for a new TB vaccine, and provided strategies to help increase vaccine confidence and uptake.
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