New Horizons for TB Vaccine Research Involve Early Awareness, Coordinated Efforts and Equitable Access: Thoughts from the 6th Annual Global Forum on TB Vaccines

Every year at the Global Forum on TB Vaccines, stakeholders from all over the world gather to discuss the development of new vaccines to prevent tuberculosis (TB). Together, they review the current state of the field, share the latest research findings and identify new and innovative approaches to TB vaccine research.
FHI Clinical had a strong presence this year at the virtual conference, with a theme of “New horizons for TB vaccines.” Our own Ghiorghis Belai, Vice President of Global Strategy, and FHI Clinical Scientific Advisory Experts, Falgunee K. Parekh, MPH, PhD, and Ben Woods, MD, presented the plenary session: Follow the EPI: Finding TB-Prevalent Populations to Guide TB Vaccine Protocol Design. In addition, Ghiorghis presented an abstract during the Clinical Research and Epidemiology track.
Meg Fromuth, Associate Director, Clinical Operations; Leonard Herbst, Global Head, Project Management; and Sanchia Theron, Global Head, Medical Affairs, who attended the virtual conference, provided some insights regarding their takeaways from the sessions they attended.
Creating early awareness of ways to prevent TB is crucial.
Data were presented from a study recently published in The Lancet regarding the link between cytomegalovirus (CMV) and TB in children. The study showed that children who acquire CMV in the first year of life are at high risk of subsequently developing TB. Per the authors, the findings suggest that efforts to prevent TB in early childhood in high-burden countries might need to involve deterring or delaying acquisition of CMV perinatally or in the first months of life.

“Yes! A major takeaway for me after listening to conference sessions is how crucial it is to raise awareness of the need for a safe and effective TB vaccine."
Sanchia Theron

Coordinated efforts are required to advance TB vaccine development.

To Meg, it seemed that many of the presenters felt that, to move forward with TB vaccine development, a coordinated multinational, financial and political sustaining effort is needed. Sanchia added that protocol design and early involvement of epidemiologic experts are key for successful study execution. This was also the focus of FHI Clinical’s plenary discussion, in which we described our four-pronged approach to site feasibility for TB vaccine trials:

  1. Biosurveillance analytic methodology
  2. Indicator and attribute scoring
  3. Epidemiological analysis
  4. Epidemiological expert assessment
TB Vaccine Trial Challenges

Identifying high TB-burden areas with eligible, treatment-naïve populations is critical to rapid enrollment, enhanced participant diversity and timely completion of TB vaccine trials. However, we are challenged by the simultaneous development and administration of TB preventive therapy (TPT) as well as varying levels of research capacity in these areas. Watch the plenary session recording to learn more about how an approach that engages clinical operations, epidemiology and other experts early, during protocol design, can be more efficient and help ensure the proposed development plan can be implemented within the target populations.

Leonard attended a session in which Dr Michèle Tameris from the South African Tuberculosis Vaccine Initiative (SATVI) presented data from the Phase 2a trial of the Mycobacterium tuberculosis vaccine (MTBVAC). This dose-defining safety and immunogenicity study, conducted with BCG-naïve newborns in South Africa, presents an important step toward achieving the World Health Organization (WHO) End TB Strategy. The 7-year Phase 3 trial is just being initiated and will extend the evaluation of MTBVAC safety and efficacy in newborns to other areas of sub-Saharan Africa.
Equitable access to TB preventive care is important.

FHI Clinical’s Global Strategy team aims to promote clinical equity through research and discourse on trial design at the global level, which was reflected in both the FHI Clinical plenary session and abstract presentation. According to Meg, health equity in the care of TB (and many other diseases) was also a popular theme throughout the conference, including in a discussion with Dr. Molebogeng Rangaka, Associate Professor at the Institute of Global Health, University College London called Impact of TPT on Clinical Trial Design. This discussion highlighted the importance of developing TB vaccine trials that help ensure vulnerable populations have access to existing preventive care.

“Where you live should not dictate IF you live."
overheard by Meg Formuth

COVID-19 continues to have an effect on TB vaccine research and development.
Leonard and Sanchia both commented that discussions reflected on the large impact of COVID-19 on vaccine research, as the funding for many other diseases has been channeled into COVID-19 vaccine development. However, many of the projects that were put on hold are now getting back into development, and we should capitalize on what we’ve learned during the pandemic, including how to develop reliable correlates of immune protection and biomarkers, to ensure successful development in the future.
FHI Clinical is positioned to help TB vaccine research with our extensive footprint in sub-Saharan Africa.
FHI Clinical is very well positioned within sub-Saharan Africa to deliver on clinical research to support our sponsors and collaborators to get new vaccines to market. With the addition of the South Africa team, we have gained a wealth of experience in TB vaccine research and increased the number of studies within the FHI Clinical portfolio significantly. Moreover, an advantageous wealth of local knowledge of the African continent, where TB is a major health concern.

“I was excited to see that FHI Clinical is the CRO for one of the current ‘front runners’ in TB vaccine development that shared data!"
Sanchia Theron

Read more about FHI Clinical’s experience with research in sub-Saharan Africa, as well as our relationships with local networks such as the Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL), and how we are positioned for successful trials in Africa.

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