Tuberculosis Clinical Trial
Official title:
A Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection With Mycobacterium Tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
This Phase II, randomized, 3-arm, placebo controlled, partially blinded, clinical trial will
be conducted in 990 healthy, HIV-uninfected, QFT-GIT negative, previously BCG vaccinated
adolescents. The trial will be conducted at the South African Tuberculosis Vaccine Initiative
(SATVI) site in the Western Cape region of South Africa, where epidemiological studies
involving thousands of adolescents have been conducted over the last decade to characterize
rates of Mtb infection and active TB disease in this age group. Subjects will be enrolled in
two sequential cohorts and within each cohort subjects will be randomized in a 1:1:1 ratio to
receive either AERAS-404 or saline placebo on Days 0 and 56, or BCG Vaccine SSI on Day 0. The
first 90 subjects (30 from each arm) will form the Safety & Immunogenicity Cohort and will be
subject to more intensive collection of safety data, with data reviewed by the Data
Monitoring Committee (DMC), principal investigator and local medical monitor. Selected
immunogenicity assays, including whole blood intracellular cytokine staining (ICS), will also
be performed in this cohort. The remaining 900 subjects will be enrolled into the Correlates
Cohort. All 990 subjects in the study will be evaluated for safety and biomarker outcomes,
and for prevention of Mtb infection.
The primary Mtb infection endpoint will be QFT-GIT conversion from a negative to positive
test, using the manufacturer's recommended threshold of 0.35 IU/mL, at any time-point after
Day 84 and through end of follow-up for the primary endpoint. The 84-day 'wash-out' period is
stipulated in order to exclude subjects who may have already been Mtb infected, but not yet
converted their QFT-GIT test at screening, thus subjects who convert their QFT-GIT at Day 84
will not be included in the analyses of prevention of Mtb infection.
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