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P1113 / AERAS-404 TB Vaccine in BCG-Primed Infants

Phase I/II, Safety and Immunogenicity Study of a Recombinant Protein Tuberculosis Vaccine (AERAS-404) in BCG-Primed Infants

Study Status

Closed to Follow Up

DAIDS Number

11911

IND Number

Non-IND

Summary

P1113 is a Phase I/II, randomized, double-blind, placebo-controlled, safety, immunogenicity and dose-range finding study of the AERAS-404 tuberculosis vaccine in HIV-unexposed, HIV-uninfected, BCG-primed South African infants.  The study is being conducted in collaboration with AERAS, Sanofi Pasteur, and Statens Serum Institut.

Study Documents

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1.32 MB

DAIDS Medical Officer

NICHD Medical Officer

Clinical Research Manager

DAIDS Clinical Representative

Data Manager

Field Representative

Laboratory Data Manager (LDM)

Laboratory Specialist

Laboratory Technologist

Proposal Statistician

SC Representative

Abstracts

Interim safety and immunogenicity results IMPAACT P1113: Phase I/II Study of AERAS-404 In BCG-Primed Infants

Conference

TB Vaccines Fourth global Forum

Study

P1113

Authors

S. Nachman, E. Andersen-Nissen, A. Gartland, J. Hural, M.J. McElrath, Z. Shi, J. Ishmukhamedov, A Coletti, Diaz Granados C , C. Worrell, P Jean-Philippe, M. Cotton, L. Fairlie, A. Violari, the P1113 study team

IMPAACT P1113/Aeras C-015-404: Phase I/II Study of H4-IC31 in BCG-Primed Infants

Conference

TB Vaccines Fourth global Forum

Study

P1113

Authors

S Nachman, E Andersen-Nissen, A Gartland, J Hural, MJ McElrath, Z Shi, J Ishmukhamedov, C DiazGranados, C Worrell, P Jean-Philippe, M Cotton, L Farlie, A Violari, The P1113 Study Team