Final Analysis of a Trial of M72/AS01E Vaccine to Prevent Tuberculosis
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Audio Transcript Auto-generated
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Good morning. My name is Donna Mascara.
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I am going to present the final analysis to a trial of M 72 slash S. 01 in
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vaccine to prevent tuberculosis.
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First of all,
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we need to know the meaning of tuberculosis
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which contributes infection that usually attacks your lungs.
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It can also spread to other parts of the
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your body
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like your brain and spain, a type of bacteria called mycobacterium tuberculosis.
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Cause
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according to the world Health organization, tuberculosis remains a leading
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cause of death from a single production globally
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and safe effective tuberculosis active
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but soon
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will be the key
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in
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editing
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the epidemic.
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The analysis of the
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primary
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trial
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objective was performing
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when all participants and complete at least two years
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or follow up
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the vaccine efficacy agent bacteriological
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confirming active pulmonary tuberculosis with significant
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significant infection site
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region and influential like symptoms occurring more frequently in the M 72 slash A.
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S 01 E. Group
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than in the placebo group.
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But serious
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advanced
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Evan
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petition
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in mano mediated diseases
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and deaths occurring with similar frequencies in the two groups.
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Now of the deaths were reality to the trial regime.
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We know present the final result of the efficacy and safety
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and analysis of their three years of follow up and the result, we're
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Henner,
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M 72 specific
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hue mural
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and the self media
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immunogenicity
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result of unheard earlier analysis of the trial
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of the vaccine proverb
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6 54%.
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Protection
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against active pulmonary tuberculosis thesis
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Without
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evidence is
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safety concerns
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methods participants were fellow for three years after the second.
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Those participants with clinical suspicion of tuberculosis provide a spoon
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samples for polymer a such a reaction safe
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proletarian culture or both
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Hugh, Meral and self mediated immune response
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were evaluated
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until month 3 6. In a group of 300 participants,
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Satie was
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highs in
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in our participants who received at least one dose of M 72 slash A. S 01 E. Or placebo.
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Yeah.
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Okay.
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Mhm.
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In conclusion among adults, in fact,
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with tuberculosis
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vaccination
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with M 72 slash S 01 E.
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Illicit
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and in modern response and provided protection against progression
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To pulmonary tuberculosis. This is for at least three years
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cause of death. Worldwide
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infection. In
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many quarters of the world's population,
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adults with latent TB runners to developing active TB infection.
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A vaccine for persons with latent TB that prevents TB
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activation could help interrupt disease
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transmission and improve disease control.
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The M- 72 vaccine contains an incompetent fusion
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protein derived from two immunogen inc TV antigens.
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Combined with an advantage.
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The goal of vaccination is to induce a protective immune response against TB,
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thus preventing active TB disease.
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This randomized controlled Phase two B trial in kenya, South Africa and Zambia
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enrolled about 3500 HIV negative adults
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18 to 50 years old
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who were healthy or with stable chronic medical conditions
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and who had confirmed latent pulmonary
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TB infection by interferon gamma release essay
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but were sputum sample negative for TB by PcR
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participants were randomized to receive two doses of either m 72 vaccine
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or placebo intra muscularly
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one month apart.
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The majority of participants have previously received the BCG vaccine.
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The primary endpoint was the incidence
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of bacteriological confirmed active pulmonary TB.
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At a mean follow up of about two years,
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there were 10 confirmed active pulmonary TB cases in
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the vaccinated group versus 22 cases in the placebo group
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for a statistically significant vaccine efficacy of 54%
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serious adverse events, potential immune mediated diseases
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and death occurred with similar frequency in both groups,
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the authors conclude that the N 72
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vaccines significantly reduced the incidence of pulmonary TB
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in healthy HIV negative
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and largely previously BCG vaccinated adults
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with latent TB.
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Full trial is also available at any j m dot org