Tuberculosis Clinical Trial
Official title:
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS‑404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.
This ia a Phase I, randomized, placebo-controlled, double-blind study in three groups of
healthy adult males or sterile females who are BCG-vaccinated, HIV-negative, and have no
evidence of tuberculosis infection.
Sixty-four subjects assigned to one of eight treatment groups to receive one of four
different antigen/adjuvant combinations of study vaccine, or placebo control. Within each
study group, subjects will be randomized to receive either a single-dose antigen/adjuvant
regimen of study vaccine (vaccination with study vaccine on Study Day 0 followed by
vaccination with placebo control on Study Day 56) or a two-dose antigen/adjuvant regimen of
study vaccine (vaccination with study vaccine on Study Days 0 and 56).
All subjects will be followed for safety and immunogenicity evaluations for 182 days.
The sample 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. If no SAE are observed among 56 subjects receiving active
study vaccine, an approximation to the upper 95% confidence bound on the rate of SAE
occurrence would be 5.4%.
;
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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