The Tuberculosis Vaccine Initiative (TBVI) and the European & Developing Countries Clinical Trials Partnership (EDCTP) developed several new tools to support future TB vaccine clinical trials: templates and guidelines to support preparations for a regulatory plan, a data management plan and clinical trial protocol synopses, and a comprehensive registry of trial sites in sub-Saharan Africa.

The Virtual Global Forum on TB Vaccines will be held on 20-22 April 2021 and will review the state of the field and recent progress in TB vaccine research and development against the backdrop of the COVID-19 pandemic.

Recently Tuberculosis has published the article The TB vaccine development pathway – An innovative approach to accelerating global TB vaccine development. The publication emphasizes the importance of a diverse TB vaccine pipeline to address the TB-specific challenges. Individual vaccine candidates must be advanced rationally and the global pipeline must be managed in the most nimble and resource-efficient way, especially in the current constrained funding environment.

The European Investment Bank (EIB) agreed a €30 million loan with Vakzine Projekt Management GmbH (VPM), the German subsidiary of Serum Institute of India Pvt. Ltd. The loan will help VPM to perform the priMe trial. The priMe project contains a multicentre phase III double-blind, randomised, controlled study to evaluate the efficacy and safety of VPM1002 in comparison to the baccille Calmette–Guérin (BCG) vaccine. Vaccine research and development for the project will be carried out by VPM and the clinical trials will be scaled up in several high-burden sub-Saharan African countries.

Biofabri, the University of Zaragoza, the South African Tuberculosis Vaccine Initiative (SATVI) and TB Vaccine Initiative (TBVI) announced the results of a Phase 1b trial of the new live attenuated TB vaccine ‘MTBVAC’ at the 5th Global Forum on TB vaccines, held on 20-23 February 2018 in New Delhi, India.

The new Spanish TB vaccine MTBVAC has received 12 million euros to carry out Phase 2a trials in new-borns and in adults in South Africa.

TBVAC2020 (a European consortium of TB R&D partners led by TBVI and funded by the EC) gives an update on its progress towards the development of new, safe and affordable TB vaccines – essential to control the TB epidemic and combat AMR.

Researchers at the University of Zaragoza (belonging to CIBERES) and the biopharmaceutical vaccine company Biofabri in Porrino, Spain in partnership with the TuBerculosis Vaccine Initiative (TBVI) are developing a new TB vaccine, MTBVAC. MTBVAC, a live attenuated M.tuberculosis vaccine, has been shown to provide improved protection as compared to BCG and the mechanism behind this greater efficacy has been hypothesized to be due to the ability of MTBVAC to present a wider collection of antigens of M. tuberculosis.

On 3 February 2016 the TuBerculosis Vaccine Initiative (TBVI) organised the symposium: TB vaccines and immunity.

Lausanne / Zaragoza / Madrid / Porriño / Lelystad, 17 November 2016 – For the first time, a live-attenuated tuberculosis vaccine – MTBVAC – has been evaluated in humans. MTBVAC – evaluated in 36 human volunteers with no signs of previous exposure to M. tuberculosis – showed excellent safety and promising immunogenicity profiles. The results of this clinical trial, conducted in Lausanne, were published yesterday in the journal THE LANCET Respiratory Medicine. Following this promising evaluation, a subsequent study that will evaluate safety and immunogenicity in humans in an endemic setting has recently started in South Africa.