drugset / Trial / NCT03159975
Safety and Immunogenicity Study of GX-70 in TB Patient
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for the prevention of relapse of tuberculosis.
Timeline
- Start
- 2018-03
- Primary completion
- 2018-08
- Completion
- 2018-08
Outcome
Outcome not reported
Stopped: “Unconfirmed research expenses”
Publications
- Results Flynn JL, Chan J. Tuberculosis: latency and reactivation. Infect Immun. 2001 Jul;69(7):4195-201. doi: 10.1128/IAI.69.7.4195-4201.2001. No abstract available.
- Results Chang KC, Leung CC, Yew WW, Ho SC, Tam CM. A nested case-control study on treatment-related risk factors for early relapse of tuberculosis. Am J Respir Crit Care Med. 2004 Nov 15;170(10):1124-30. doi: 10.1164/rccm.200407-905OC. Epub 2004 Sep 16.
- Results Ahn SS, Jeon BY, Kim KS, Kwack JY, Lee EG, Park KS, Sung YC, Cho SN. Mtb32 is a promising tuberculosis antigen for DNA vaccination in pre- and post-exposure mouse models. Gene Ther. 2012 May;19(5):570-5. doi: 10.1038/gt.2011.140. Epub 2011 Sep 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GX-70 | Vaccine | 0.26 mg | Intramuscular |
| Subject | GX-70 | Vaccine | 1 mg | Intramuscular |
| Subject | GX-70 | Vaccine | 4 mg | Intramuscular |