MedDataX Logo

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

NCT ID: NCT00440544

Last Updated: 2008-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Tuberculosis vaccine nasal immunization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

100 ug H1 antigen alone in BCG naive subjects

Group Type EXPERIMENTAL

Ag85B-ESAT6 fusion protein H1

Intervention Type BIOLOGICAL

100 ug H1 antigen in BCG naive subjects

2

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects

Group Type EXPERIMENTAL

Ag85B-ESAT6 fusion protein H1

Intervention Type BIOLOGICAL

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects

3

50 ug H1 antigen in BCG immunized subjects

Group Type EXPERIMENTAL

Ag85B-ESAT6 fusion protein H1

Intervention Type BIOLOGICAL

50 ug H1 antigen in BCG immunized subjects

4

50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Group Type EXPERIMENTAL

Ag85B-ESAT6 fusion protein H1

Intervention Type BIOLOGICAL

50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

5

100 ug H1 antigen in BCG immunized subjects

Group Type EXPERIMENTAL

Ag85B-ESAT6 fusion protein H1

Intervention Type BIOLOGICAL

100 ug H1 antigen in BCG immunized subjects

6

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Group Type EXPERIMENTAL

Ag85B-ESAT6 fusion protein H1

Intervention Type BIOLOGICAL

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ag85B-ESAT6 fusion protein H1

100 ug H1 antigen in BCG naive subjects

Intervention Type BIOLOGICAL

Ag85B-ESAT6 fusion protein H1

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects

Intervention Type BIOLOGICAL

Ag85B-ESAT6 fusion protein H1

50 ug H1 antigen in BCG immunized subjects

Intervention Type BIOLOGICAL

Ag85B-ESAT6 fusion protein H1

50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Intervention Type BIOLOGICAL

Ag85B-ESAT6 fusion protein H1

100 ug H1 antigen in BCG immunized subjects

Intervention Type BIOLOGICAL

Ag85B-ESAT6 fusion protein H1

100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed informed consent
* Healthy, based on medical examination at inclusion
* Male or female subjects, aged between 18 and 55 years
* Willing and likely to be able to comply with the trial procedures
* Prepared to grant authorized persons access to their medical records

Additional inclusion criterion for BCG-non-vaccinated subjects:

* BCG-non-vaccinated (i.e., absence of a BCG-scar)
* Negative Mantoux skin test

Additional inclusion criterion for BCG-vaccinated subjects:

* BCG-vaccinated (i.e., presence of a BCG-scar)

Exclusion Criteria

* History of TB or known exposure to TB
* Radiological findings on chest X ray compatible with previous or current infection with tuberculosis
* Positive QuantiFERON® TB-Gold test Evidence of previous, current or latent tuberculosis
* Evidence of previous, current or latent tuberculosis
* History of severe organ-system diseases
* Known hypersensitivity to any of the vaccine components
* History of allergic disorders
* Vaccinated with other vaccine within 3 months before first vaccination
* Congenital and/or acquired immune diseases
* Administration of systemic immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulin) within 3 months before the first vaccination (topical steroids not included)
* Autoimmune diseases
* HIV, HBV and HCV sero-positive
* Established diagnosis of a neurological or neuromuscular disease, and specifically any history of abnormality with respect to sense of smell (olfactory nerve dysfunction), or previous or current facial nerve paralysis
* Congenital or acquired abnormalities or disorders related to nasal and nasopharyngeal cavities
* Current use of any medication taken through the nasal/inhalatory route including cocaine or other drugs
* Laboratory parameters outside of normal ranges considered clinically significant
* Pregnant according to urine pregnancy test
* Females not willing to use contraceptives or who are breastfeeding
* Intake of trial medication in other clinical trials within 6 months of the first vaccination
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Statens Serum Institut

OTHER

Sponsor Role collaborator

Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SGUL

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David JM Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London, UK

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St George's Vaccine Institute

London, England, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://www.vaccine.ac.uk

St George's Vaccine Institute Home website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT Number: 2005-005140-81

Identifier Type: -

Identifier Source: secondary_id

FP6-2002-LIFESCIHEA-2.3 503240

Identifier Type: -

Identifier Source: secondary_id

TMUVA-01

Identifier Type: -

Identifier Source: org_study_id