Tuberculosis Clinical Trial
Official title:
A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of AERAS-402 in BCG-vaccinated, HIV-uninfected Infants Without Evidence of Tuberculosis
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
The only currently available tuberculosis vaccine, bacillus Calmette-Guérin (BCG), is
estimated to reduce the risk of tuberculosis (TB) in children by up to 70-80%, but
protection is incomplete. Efforts to increase TB protection in children include new vaccines
for primary immunizations as well as combinations of vaccines given as primary and boosting
vaccinations.
AERAS 402 is a live recombinant serotype 35 replication deficient adenovirus vector
expressing a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens (Ag85A, Ag85B
and TB10.4). It presents Mtb antigens in the setting of a new, live, replication-deficient
adenovirus vaccine that may increase T cell-mediated immunity and thus protection from
tuberculosis. AERAS-402 appears safe and immunogenic in adults. Since BCG-vaccinated infants
are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to
infants of at least 16 weeks of age who have already been vaccinated with BCG. This is the
first Phase II study of AERAS-402 in infants.
;
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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