drugset

drugset / Trial / NCT00929396

A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers

NCT00929396 ↗

Phase 1 Completed 20 enrolled Statens Serum Institut

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.

Timeline

Start: 2007-09
Primary completion: 2009-06
Completion: 2009-06

Publications

van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ag85B-ESAT-6	Vaccine	50 ug	Other
Background	IC31	Other / unclassified	—	Other

Indications