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Safety and Immunogenicity of the Recombinant BCG Vaccine AERAS-422 in Healthy BCG-naïve Adults: A Randomized, Active-controlled, First-in-human Phase 1 Trial
Author(s) -
Daniel F. Hoft,
Azra Blazevic,
Asmir Selimovic,
Aldin Turan,
Jan Tennant,
Getahun Abate,
John P. Fulkerson,
Daniel E. Zak,
Robert Walker,
Bruce McClain,
Jerry Sadoff,
Judy Scott,
Barbara Shepherd,
Jasur Ishmukhamedov,
David A. Hokey,
Veerabadran Dheenadhayalan,
Steven G. Smith,
Lynn M. Amon,
Garnet Navarro,
Rebecca Podyminogin,
Alan Aderem,
Lew Barker,
Michael J. Brennan,
Robert S. Wallis,
Anne A. Gershon,
Michael D. Gershon,
Sharon Steinberg
Publication year - 2016
Publication title -
ebiomedicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.596
H-Index - 63
ISSN - 2352-3964
DOI - 10.1016/j.ebiom.2016.04.010
Subject(s) - immunogenicity , medicine , recombinant dna , virology , bcg vaccine , randomized controlled trial , immunology , vaccination , biology , antibody , gene , genetics
We report a first-in-human trial evaluating safety and immunogenicity of a recombinant BCG, AERAS-422, over-expressing TB antigens Ag85A, Ag85B, and Rv3407 and expressing mutant perfringolysin.

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