Tuberculosis Clinical Trial
Official title:
A Randomized, Placebo-controlled, Partially Blinded Phase 1b Clinical Trial to Evaluate the Safety and Immunogenicity of BCG Revaccination, H4:IC31, and H56:IC31 in Healthy, HIV-1-Uninfected Adolescent Participants
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to provide leads for biomarkers of protection against tuberculosis. This study will complement one ongoing study (NCT02075203) evaluating the prevention of M. Tuberculosis infection using H4:IC31 (also known as AERAS-404).
This study proposes to further evaluate the safety and immunogenicity of H4:IC31, H56:IC31,
and BCG revaccination. The study will be conducted in previously BCG vaccinated healthy
adolescents, and will entail a thorough immunogenicity evaluation of these regimens
incorporating unbiased systems vaccinology approaches and novel assessments of baseline and
elicited responses that may impact vaccine responses. A major goal for this study is to
generate immunological data on a wide range of immune responses using a variety of approaches
including validated assessments, unbiased strategies, and novel exploratory assays to
increase the likelihood of detecting responses correlating with risk or protection in the
prevention of infection study. Investigators contributing to the proposed study have
participated in a correlates analysis for an HIV vaccine exhibiting modest efficacy in which
2 correlates of risk were identified.
An additional aim of this study is to explore factors affecting vaccine induced responses
that may also impact efficacy. For example, it is hypothesized that exposure to environmental
mycobacteria may alter protection provided by BCG vaccination. Reagents for evaluating levels
of exposure to environmental mycobacteria are in development as part of a concurrent
collaborative study. An exploratory objective for this trial is to apply these reagents to
examine whether such exposures influence immune responses elicited by the study vaccine and
regimens.
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