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

NCT00440544 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2008-11-03

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Novartis Vaccines

    collaborator INDUSTRY

  • European Union

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • David JM Lewis, MD · St George's, University of London, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-11-30
Completion
2008-02-29

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440544 on ClinicalTrials.gov