Completed Infection & Immunity Lungs & Breathing

Clinical Development of a Therapeutic Vaccine for Tuberculosis.

Funder Wellcome Charity-funded
Recipient organisation Infectious Disease Research Institute
Funding £3.9M
Period Jan 2015 — May 2023

In plain English

AI plain-English summary

A new tuberculosis vaccine, ID93/GLA-SE, is about to be tested in people who have already had the disease, to see if it can prevent the infection from coming back. Drug-resistant tuberculosis is a growing global threat, and existing treatments are long, toxic, and increasingly ineffective. Standard vaccines prevent initial infection but do nothing once someone has been sick. This trial addresses a critical gap: whether a therapeutic vaccine—one given after infection—can train the immune system to control or eliminate lingering bacteria that cause relapse. If successful, this approach could transform TB management. Instead of relying solely on months of antibiotics, patients might receive a short vaccine course to reduce recurrence rates. For health systems in high-burden countries, that would mean fewer treatment failures, less drug resistance, and lower costs. The vaccine is owned by a non-profit, so if it works, it could be made affordable where it is needed most. The study is a proof-of-concept trial focused on safety and immune response. It will also define a clinical pathway for future therapeutic TB vaccines—a step that has been missing from the field.

View original technical description
The urgency of drug-resistant tuberculosis (TB) demands new and innovative therapeutic approaches, including the use of therapeutic vaccines. The IDRI team has a long history of TB vaccine development, and the SATVI team is clearly the leading clinical TB vaccine evaluation group in the world. Based on the experience of developing the M72 vaccine candidate with GSK, the IDRI team embarked on a ten year TB vaccine research and development program, using novel technologies and strategies, resultin g in a new clinical stage candidate, ID93/GLA-SE. The candidate consists of four complementary protein antigens formulated in a synthetic TLR4 agonist, GLA, proven safe and effective in several clinical trials. The ID93/GLA-SE candidate, currently in early stage clinical development in the US, and the only advanced TB vaccine candidate owned entirely by a non-profit entity, was shown to be effective for vaccine therapy against fatal Tb in animals. The current proposal is designed to demonstrate safety and immunogenicity in subjects with a past history of TB disease, leading to proof of concept of a therapeutic vaccination strategy. Importantly, the study will define a clinical development strategy for the development of therapeutic vaccines for TB.

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Researchers

Steven Reed (EPMC Awardee)

Related Research

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A clinical study comparing the immune response to revaccination with intradermal BCG and aerosol BCG in previously BCG vaccinated healthy adult volunteers with and without Type 2 Diabetes
A clinical trial evaluating the safety of an aerosol BCG controlled human infection model in assessing the immunogenicity of historical BCG vaccination and vaccination with ID93/GLA-SE in healthy adult volunteers

Original classification

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