Tuberculosis Clinical Trial
Official title:
A Phase I Randomized Placebo-controlled Double-blind Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QuantiFERON®-TB Gold (+) and QuantiFERON®-TB Gold (-) Adults Without Evidence of Tuberculosis.
The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication deficient adenovirus vaccine that may increase T cell immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals in Kenya who have already been vaccinated with BCG.
This Phase I study will be conducted as a double-blind, randomized, placebo-controlled study
in 20 healthy adult subjects. The study will enroll 10 subjects who are QFT-G positive at
screening and 10 subjects who are QFT-G negative at screening. Within QFT-G group, subjects
will be randomized to receive AERAS-402 or placebo in a ratio of 4:1. One dose level of
AERAS-402 (3 x 10^10 vp) will be investigated in this study. All subjects will receive a
single dose of study vaccine (AERAS-402 or placebo) on Study Day 0 and a second dose of
study vaccine (AERAS-402 or placebo) on Study Day 56. All vaccinations will be administered
by IM injection into the deltoid muscle.
The sample size was selected as adequate for preliminary safety evaluations and initial
immunogenicity reviews for this phase study, rather than for statistical reasons. If no
serious adverse events are observed in 16 subjects who receive AERAS-402, the upper bound of
the 95% confidence interval on the rate of serious adverse event occurrence is 17.1 percent.
The selection of AERAS-402 dose level for evaluation in this study was derived from animal
studies and based on the safety profile for the completed and ongoing clinical studies in
the U.S. and South Africa.The total duration of follow-up is 182 days for each subject with
a total of eleven follow-up clinic visits. The study is planned at a single site in Kisumu,
Kenya.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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