drugset / Trial / NCT00440544
A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)
Phase 1
Terminated
9 enrolled
St George's, University of London
European Union · collabNovartis Vaccines · collabStatens Serum Institut · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. Both subjects who have not received Bacillus Calmette-Guerin (BCG) and subjects who have already received BCG will be enrolled. An initial evaluation of immune responses to the vaccine will also be undertaken.
Timeline
- Start
- 2007-01
- Primary completion
- 2007-11
- Completion
- 2008-02
Outcome
Outcome not reported
Stopped: “Safety Issues”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ag85B-ESAT6 fusion protein H1 | Vaccine | 50 ug | Intranasal |
| Subject | Ag85B-ESAT6 fusion protein H1 | Vaccine | 100 ug | Intranasal |