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A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402

NCT02375256 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-03-03

No results posted yet for this study

Summary

Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on Study Days 0 and 28. Subjects were followed for a total of 98 days.

Conditions

Interventions

BIOLOGICAL

AERAS-402

Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).

BIOLOGICAL

Placebo

Identical buffer solution in which AERAS-402 is formulated.

BIOLOGICAL

BCG (1-8 x105 cfu ID)

BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.

Sponsors & Collaborators

  • Aeras

    lead OTHER

Principal Investigators

  • Ann M Ginsberg, MD PhD · Aeras

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-12-31
Completion
2013-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02375256 on ClinicalTrials.gov