A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6) (TMUVA-01)

October 31, 2008 updated by: St George's, University of London

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SW17 0RE
        • St George's Vaccine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
100 ug H1 antigen alone in BCG naive subjects
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
Experimental: 2
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
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
Experimental: 3
50 ug H1 antigen in BCG immunized subjects
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
Experimental: 4
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
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
Experimental: 5
100 ug H1 antigen in BCG immunized subjects
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
Experimental: 6
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To evaluate the safety profile (medical examinations, adverse events and laboratory safety tests) of a nasal TB subunit vaccine with and without adjuvant given as two doses with 2 months interval.
Time Frame: 8 months
8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To evaluate the cell mediated and humoral immunogenicity profile of a nasal TB subunit vaccine with and without adjuvant, given as two doses with 2 months interval.
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St George's, University of London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis Vaccines
Statens Serum Institut
European Union

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMUVA-01
  • FP6-2002-LIFESCIHEA-2.3 503240
  • EudraCT Number: 2005-005140-81

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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