Trials / Completed
CompletedNCT01198366
Study of AERAS-402 in Healthy Infants
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 487 (actual)
- Sponsor
- Aeras · Academic / Other
- Sex
- All
- Age
- 112 Days – 182 Days
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AERAS-402 1.5 x 10^10 vp | |
| BIOLOGICAL | AERAS-402 3.0 x 10^10 vp | |
| BIOLOGICAL | AERAS-402 1.0 x 10^11 vp | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2014-01-01
- Completion
- 2014-04-01
- First posted
- 2010-09-10
- Last updated
- 2017-05-08
- Results posted
- 2015-08-04
Locations
7 sites across 3 countries: Kenya, Mozambique, South Africa
Source: ClinicalTrials.gov record NCT01198366. Inclusion in this directory is not an endorsement.