Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region

Summary

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start

2008-02-05

Primary completion

2008-12-19

Completion

2008-12-19

Publications

• Background Day CL, Tameris M, Mansoor N, van Rooyen M, de Kock M, Geldenhuys H, Erasmus M, Makhethe L, Hughes EJ, Gelderbloem S, Bollaerts A, Bourguignon P, Cohen J, Demoitie MA, Mettens P, Moris P, Sadoff JC, Hawkridge A, Hussey GD, Mahomed H, Ofori-Anyinam O, Hanekom WA. Induction and regulation of T-cell immunity by the novel tuberculosis vaccine M72/AS01 in South African adults. Am J Respir Crit Care Med. 2013 Aug 15;188(4):492-502. doi: 10.1164/rccm.201208-1385OC.

Drugs

Indications