Tuberculosis Infection Clinical Trial
Official title:
A Randomized, Placebo Controlled, Double-Blind Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection With Mycobacterium Tuberculosis (Mtb) of H56:IC31 in Healthy Adolescents
This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents.
This clinical trial will evaluate safety, immunogenicity, and prevention of Mtb infection,
(measured by IGRA conversion) of H56:IC31 in remotely BCG vaccinated adolescents. A TB
vaccination strategy incorporating H56:IC31 in adolescents or young adults, if found to
prevent Mtb infection, would likely have a major impact on TB disease, TB transmission, and
control of the epidemic. If vaccination with H56:IC31 is shown to prevent infection with Mtb
in this proof of concept study in adolescents, additional larger scale studies examining the
impact on TB disease in more diverse populations would be warranted.
Primary objectives
- To evaluate the safety profile of H56:IC31 compared to placebo in HIV-uninfected,
remotely BCG vaccinated adolescents.
- To evaluate prevention of Mtb infection by H56:IC31 compared to placebo, as measured by
rates of conversion using an ESAT-6 free IGRA.
Secondary objectives
- To evaluate prevention of Mtb infection by H56:IC31 compared to placebo, as measured by
rates of sustained conversion using an ESAT-6 free IGRA.
- To evaluate trends in ESAT-6 free IGRA prolonged/sustained conversions and late
reversions (i.e., through more than 6 months post initial conversion) in ESAT-6 free
IGRA converters.
- To investigate the immunogenicity of H56:IC31 in HIV-uninfected, remotely BCG vaccinated
adolescents.
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