The recent Virtual Global Forum on TB Vaccines brought together over 300 participants from more than 30 countries to share data, concepts and new approaches to TB vaccine research, as well as promote a global dialogue on the path forward.
As part of the conference, FHI Clinical sponsored a discussion on the impact of TB preventive treatment (TPT) as standard of care on TB vaccine development. The prestigious panel consisted of:
What is TPT?
TPT is intended to prevent latent TB infection from progressing to active, symptomatic disease. It typically involves administering one or more anti-TB drugs and aims to reduce the morbidity and mortality associated with active TB disease.
FHI Clinical Scientific Advisory Expert and Founder and Principal Scientist, EpiPointe
FHI Clinical Scientific Advisory Expert and Pediatric Infectious Disease Physician
The panelists briefed attendees on the new World Health Organization Guidelines for TPT and introduced some of the implications for TB vaccine development. They then invited attendees to discuss these issues.
Ghiorghis Belai kicked things off, acknowledging the many questions and issues that experts in the field are currently grappling with around this topic. Panelists and attendees were prompted to think about questions facing the state of TB vaccine development, including:
- What is the impact of TPT on vaccine development?
- How does TPT affect the design of vaccine trials?
- How do we identify targets if we are considering interferon gamma release assay (IGRA) positive but no active disease vs. IGRA negative but high-risk participants?
- Should we even include these groups?
- How can we target high-risk populations? And how can we be sure that these groups will not be eligible for TPT at some point during the trial?
- How do you assess the need for a booster vaccine?
- What about the long-term protection of the vaccine?
- How will TPT affect long-haul COVID survivors?
Polling questions
A poll was also conducted during the presentation, during which attendees were asked a series of questions related to TPT.
How important is TPT roll-out to controlling TB
Is TB considered a public health issue in the setting in which you work?
What type of vaccine would be best suited for your country?
Not surprisingly, the majority of attendees considered the roll-out of TPT to be “very important” in the setting in which they work. While a lesser majority considered TB a public health issue in their area, most attendees felt that vaccines targeting prevention of either disease or infection are most critical for their region.
Expert panelist perspective
We asked panelist and FHI Clinical Scientific Advisory Expert, Falgunee K. Parekh, a few questions to summarize her thoughts on the experience.
Q: What was your biggest takeaway from the discussion?
One thought that stayed with me was the impact it would have if we were able to implement ongoing surveillance to obtain time series data on incidences of TB. We could use that data to assess changes in TB epidemiology in the context of TPT implementation.
Q. What do you think the TB vaccine community needs to talk more about?
Moving forward, I think the TB vaccine community should explore alternative clinical study designs.
Q. What surprised you most from the panel discussion?
I was surprised by the idea of planning the statistical analysis of a clinical trial to allow for adjustments of changing incidence in the context of TPT.
Q. Were the poll results what you expected? Any surprises or additional insights?
The poll results made me realize that we could bring TPT implementation and TB vaccine development together. That way, we could leverage TPT contact tracing efforts to identify high-risk individuals who may be eligible to participate in a TB vaccine clinical trial.
Community collaboration
As one of the participants said during the roundtable, we shouldn’t be satisfied with the current status of TB vaccine research. As a community, we’re looking for lots of ways to collaborate with private enterprise, academia, governments and local communities to proactively prevent TB and reach different populations at different times to keep people healthy. There are some exciting prospects in TB vaccines, and we hope panels like this can call attention to the importance of vaccine trials so we have multiple options to choose from.
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