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The implications of using different time horizons when evaluating investment to prevent infectious disease

A lifetime time horizon is conventional for cost-effectiveness analysis, but not routine for transmission-dynamic modeling, given uncertainty in future epidemiological dynamics and high computation costs. We demonstrate implications of alternative analytic time horizons with a case study of novel tuberculosis (TB) vaccine introduction

IGRA prevalence study

2024-2025

Planned

A cross-sectional study to determine IGRA positivity rate to assess eligibility for participation in tuberculosis (TB) vaccine efficacy trials

Insights into TB vaccine acceptability among adolescents in Khayelitsha through community engagement

Ongoing

Initially designed as an internal assessment of the impact of engagement workshops, we used short surveys to understand high-school learner perspectives of vaccines, focusing on COVID 19, TB and HIV vaccines. Between 2022 and 2024, we collected responses from 350 adolescents (14-18 years old). All participants live in Khayelitsha, where high rates of TB (4224 cases notified in the last year) intersect with socio-economic challenges

Modelling to estimate the health impact of novel tuberculosis vaccines on TB burden in people living with HIV

2023-2024

Hypothetical vaccine

Ongoing

This project will inform tuberculosis (TB) prevention efforts by estimating the health impact of novel tuberculosis vaccines on TB burden in people living with HIV (PLHIV) using a novel Mycobacterium tuberculosis transmission model. HIV confers the largest relative risk of TB, and new TB vaccines could be an important tool to prevent TB; however, modelling studies have not systematically investigated how new vaccines will affect TB burden in PLHIV. In stage 1 of this project, we aim to investigate TB vaccine impact in PLHIV where vaccine product characteristics and delivery vary by recipient HIV status. In stage 2, we aim to quantify how complex vaccine targeting strategies and incorporating additional granularity in HIV/AIDS natural history might affect vaccine impact estimates in PLHIV

New tuberculosis vaccines are in late-stage trials, but how confident is the public in high burden countries in vaccines?

Ongoing

With tuberculosis (TB) vaccine candidates in late-stage trials, it is important to prepare for implementation to avoid delays upon licensure. General confidence in vaccines has been identified as an anticipated barrier to introducing new TB vaccines. In the absence of detailed TB specific vaccine acceptability and confidence data, we analysed currently available vaccine confidence data in countries appearing on one of the World Health Organization (WHO) high burden lists to investigate vaccine confidence in countries with a high TB burden

FAST-TB MOD

2023-2026

Hypothetical vaccine

Ongoing

FAST-TB population and cost-effectiveness modelling core: This project will accelerate tuberculosis (TB) research translation by using mathematical modelling to address key priority questions as part of FAST TB, linking an expanded state-of-the-art modelling framework with country level data and cross consortium communication around new TB treatment regimens, diagnostics and other interventions.

Creating evidence to support tuberculosis (TB) national and global decision-makers in reducing the global burden of TB

2024-2028

Hypothetical vaccine

Ongoing

In strong collaboration, we (India, South Africa, Brazil, Indonesia, UK) will create evidence to strengthen capacity and sustainably support high tuberculosis (TB) burden countries (HBC) and global decision-makers in reducing the global burden of TB, by using modelling tools to address key questions on drug-resistant (DR-)TB, new TB vaccines and other interventions, and extend and apply a state-of-the-art TB model, to estimate the relative health, cost-effectiveness, and budget impact, of new and existing interventions, as well as their optimal combination.

Prep4TBVax

2023-2025

M72/AS01e, MTBVAC

Planned

New TB vaccines are likely to be crucial in addressing the ongoing TB pandemic. With multiple promising vaccine candidates in the pipeline and the earliest availability of a candidate expected by 2028, it is of outmost importance that once available, the vaccine can be implemented rapidly and effectively. Limited research has looked at the delivery strategies available to provide a new TB vaccine to beneficiaries and therefore, this study assesses the acceptability and feasibility of delivery strategies for the vaccine candidates M72/AS01e and MTBVAC in Ethiopia, Nigeria, and Tajikistan.

Perceptions of the incarcerated population regarding tuberculosis research and vaccines

Ongoing

A qualitative study that aims to understand to perceptions and attitudes regarding TB, TB vaccines, and participation in TB vaccine trials among persons deprived of liberty (PDR) in Brazil.

Measuring indirect transmission-reducing effects in tuberculosis vaccine efficacy trials: why and how?

2023

Hypothetical vaccines

Completed

Tuberculosis is the leading bacterial cause of death globally. In 2021, 10·6 million people developed symptomatic tuberculosis and 1·6 million died. Seven promising vaccine candidates that aim to prevent tuberculosis disease in adolescents and adults are currently in late-stage clinical trials. Conventional phase 3 trials provide information on the direct protection conferred against infection or disease in vaccinated individuals, but they tell us little about possible indirect (ie, transmission-reducing) effects that afford protection to unvaccinated individuals. As a result, proposed phase 3 trial designs will not provide key information about the overall effect of introducing a vaccine programme. Information on the potential for indirect effects can be crucial for policy makers deciding whether and how to introduce tuberculosis vaccines into immunisation programmes. We describe the rationale for measuring indirect effects, in addition to direct effects, of tuberculosis vaccine candidates in pivotal trials and lay out several options for incorporating their measurement into phase 3 trial designs