The first vaccine that can prevent tuberculosis will come soon

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Effectiveness 54%! No new vaccine has been released in 102 years, and the world’s first vaccine will be born?

Recently, the Bill & Melinda Gates Foundation and the Wellcome Foundation announced that they will invest US$550 million for a phase 3 clinical trial of the tuberculosis candidate vaccine M72/AS01E, which is mainly used to prevent adolescents and adults from suffering from tuberculosis.

Before that, only BCG vaccine could be used to prevent tuberculosis in infants and young children in the world, and BCG vaccine came out in 1921, and in the following 102 years, no vaccine was available to prevent tuberculosis.

If the Phase 3 clinical trial of M72/AS01E is successful, it will become the first vaccine that can prevent tuberculosis in adolescents and adults on the market in a century.

The vaccine was 54% effective, M72/AS01E clinical phase 2b results announced

It is reported that the candidate vaccine was developed by the pharmaceutical company GSK and consists of M72 recombinant fusion protein and adjuvant AS01. At present, the vaccine has completed phase 2 clinical trials and is about to enter phase 3 clinical trials.

In terms of effectiveness , the results of the clinical 2b trial showed that 10 participants who received M72/AS01E met the case definition, that is, they were infected with tuberculosis. In contrast, 22 participants in the placebo group met the case definition, so the vaccine efficacy was 54%.

The first vaccine that can prevent tuberculosis will come soon

Efficacy of M72/AS01 versus placebo

Image source: Reference 1

In terms of safety , within 30 days after injection, there were more adverse event reports in the M72/AS01E group (67.4%) than in the placebo group (45.4%), and the differences were mainly due to injection site reactions and flu-like symptoms. Among the two groups- Serious adverse events, but with similar rates of underlying immune-mediated disease and death.

The above phase 2 clinical trial results show that M72/AS01E has a very high potential in preventing tuberculosis. It may become the first vaccine in the world that can effectively prevent tuberculosis in adolescents and adults in the past century.

The study further showed that for every $1 invested in a 50% effective vaccine, an economic benefit of $7 could be generated in avoided health costs and increased productivity.

Therefore, if the M72/AS01E vaccine can finally be launched on the market, it will greatly reduce new cases of tuberculosis and deaths, and at the same time generate economic benefits of up to tens of billions, and the rate of return will be about 7 times that of the investment.

It is estimated that in 2021, there will be 10.6 million new cases of tuberculosis worldwide, and 1.6 million deaths from tuberculosis – equivalent to about 4,300 deaths per day.

Tuberculosis primarily affects people in low- and middle-income countries, and poor people who live and work in poor conditions and are malnourished tend to be at highest risk of developing tuberculosis.

Globally, up to a quarter of the population is estimated to have latent TB infection. These people are infected with TB bacteria without any symptoms, but are at risk of developing active TB disease.

“While TB is curable, it remains one of the leading causes of death in South Africa,” said Nomathamsanqa Majozi, director of public education at the Africa Health Research Institute. Where I live and work, more than half of the people have had or will develop TB at some point in their lives, and the consequences are devastating for individuals and communities. There is new hope for the future of TB.”

The Phase III clinical trial will be conducted by the Bill & Melinda Gates Institute of Medicine to evaluate the effectiveness of the vaccine candidate in preventing latent TB infection from progressing to tuberculosis.

The clinical trial will be carried out in cooperation with an international alliance of several tuberculosis clinical research institutions. It plans to recruit about 26,000 people in more than 50 trial sites in Africa and Southeast Asia, including people who have been infected with HIV but not infected with tuberculosis .

Gates Medical Institute will announce more information about the clinical trial design and participants in the coming months.

As one of 17 TB vaccine candidates currently in development, the M72 vaccine candidate has been in development since the early 2000s and was developed by GlaxoSmithKline and the Global TB Vaccine Foundation (Aeras), International Developed in collaboration with the AIDS Vaccine Initiative (IAVI), with partial funding from the Gates Foundation.

In a phase IIb trial, M72 showed around 50% effectiveness in reducing the development of TB in adults with latent TB infection, the highest level of efficacy in TB vaccine research over the past few decades.

Reference:

[1]Phase2bControlledTrialofM72/AS01EVaccinetoPreventTuberculosis.

The first vaccine that can prevent tuberculosis will come soon

(source:internet, reference only)

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