NCT00440544

A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)

A Phase I Trial of the Safety and Immunogenicity of an Adjuvated TB Subunit Vaccine (Ag85B-ESAT6 + LTK63) Administered at 0 and 2 Months

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 BCG and subjects who have already received BCG will be enrolled. An initial evaluation of immune responses to the vaccine will also be undertaken using flow cytometry to enumerate antigen specific IFNg containing T cells; ELISPOT to determine IFNg secreting antigen specific T cells; serology and nasal wash antibody.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	Ag85B-ESAT6 fusion protein H1	100 ug H1 antigen in BCG naive subjects
BIOLOGICAL	Ag85B-ESAT6 fusion protein H1	100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
BIOLOGICAL	Ag85B-ESAT6 fusion protein H1	50 ug H1 antigen in BCG immunized subjects
BIOLOGICAL	Ag85B-ESAT6 fusion protein H1	50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
BIOLOGICAL	Ag85B-ESAT6 fusion protein H1	100 ug H1 antigen in BCG immunized subjects
BIOLOGICAL	Ag85B-ESAT6 fusion protein H1	100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-11-01
• Completion: 2008-02-01
• First posted: 2007-02-27
• Last updated: 2008-11-03

Locations

1 site across 1 country: United Kingdom