Latent Tuberculosis Clinical Trial
Official title:
Phase I Open Label Dose-Escalation Study to Evaluate the Safety and Immunogenicity of H56:IC31 (AERAS-456) in HIV-negative Adults With and Without Latent Tuberculosis Infection
This is a Phase I, open-label, dose-escalation study with three study groups. This study will be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection (LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is AERAS-456 at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by intramuscular injection.
This is a Phase I, open-label, dose-escalation study with three study groups. This study will
be conducted in 25 HIV negative subjects, 17 of whom will have Latent Tuberculosis Infection
(LTBI) and 8 of whom will not have LTBI at study enrollment. The investigational product is
H56:IC31 (AERAS-456) at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a
dose of 50 ug of H56 antigen with IC31 500 nmol KLK (50/500). The vaccine is administered by
intramuscular (IM) injection.
Subjects will be assigned to a study group based on LTBI status at enrollment and time of
completion of screening. Subjects without LTBI will be assigned to Group 1. Subjects with
LTBI will be sequentially assigned to Groups 2 and 3 based on the order in which they
complete screening. All subjects will receive a first dose of study vaccine on Study Day 0, a
second dose of study vaccine on Study Day 56, and a third dose of study vaccine on Study Day
112. Enrollment of subjects into Group 2 will begin only after a review of safety data from
the 14-day period after initial vaccination of all subjects in Group 1. Likewise, enrollment
of subjects into Group 3 will begin only after the corresponding review of safety data from
Group 2.
The total duration of study follow-up for all subjects is 210 days. Study groups 1-2 will
enroll 8 subjects each and study group 3 will enroll 9 subjects. This study is planned at a
single clinical site in South Africa. The sizes specified for each study group were selected
because they are judged to be adequate for preliminary safety and immunogenicity evaluations
for a Phase I study rather than for statistical reasons.
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