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

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

Interventional

Enrollment (Actual)

9

Phase

  • 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

    • 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

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
Intervention / Treatment
Experimental: 1
100 ug H1 antigen alone in BCG naive subjects
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
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
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
Experimental: 3
50 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
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
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
Experimental: 5
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
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
100 ug H1 antigen in BCG naive subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
50 ug H1 antigen in BCG immunized subjects
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
100 ug H1 antigen in BCG immunized subjects
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects

What is the study measuring?

Primary Outcome Measures

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

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.

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.

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

January 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 26, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2008

Last Update Submitted That Met QC Criteria

October 31, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Other Study ID 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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