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

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

Background: 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. Methods: This was a randomized, double-blind, dose-escalation trial in HIV-negative, healthy a...

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Bibliographic Details
Main Authors: Daniel F. Hoft, Azra Blazevic, Asmir Selimovic, Aldin Turan, Jan Tennant, Getahun Abate, John Fulkerson, Daniel E. Zak, Robert Walker, Bruce McClain, Jerry Sadoff, Judy Scott, Barbara Shepherd, Jasur Ishmukhamedov, David A. Hokey, Veerabadran Dheenadhayalan, Smitha Shankar, Lynn Amon, Garnet Navarro, Rebecca Podyminogin, Alan Aderem, Lew Barker, Michael Brennan, Robert S. Wallis, Anne A. Gershon, Michael D. Gershon, Sharon Steinberg
Format: Article
Language:English
Published: Elsevier 2016-05-01
Series:EBioMedicine
Subjects:
Tuberculosis;
Recombinant BCG;
Herpes zoster;
Transcriptomes;
Functional T cell assays
Online Access:http://www.sciencedirect.com/science/article/pii/S2352396416301451

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