TuberculosisPhase 1TMUVA-01NCT00440544
A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)
A Phase 1 study testing Ag85B-ESAT6 fusion protein H1 in people with Tuberculosis, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Ag85B-ESAT6 fusion protein H1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's Vaccine Institute
London, England, SW17 0RE
About this study
Official title: 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.
Read the 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
- Being tested
- Ag85B-ESAT6 fusion protein H1
- Keywords
- Tuberculosis, vaccine, nasal immunization
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ag85B-ESAT6 fusion protein H1Biological
100 ug H1 antigen in BCG naive subjects
Ag85B-ESAT6 fusion protein H1Biological
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
Ag85B-ESAT6 fusion protein H1Biological
50 ug H1 antigen in BCG immunized subjects
Ag85B-ESAT6 fusion protein H1Biological
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
Ag85B-ESAT6 fusion protein H1Biological
100 ug H1 antigen in BCG immunized subjects
Ag85B-ESAT6 fusion protein H1Biological
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 100 ug H1 antigen alone in BCG naive subjects Receives: Biological: Ag85B-ESAT6 fusion protein H1 |
| 2 | Experimental | 100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects Receives: Biological: Ag85B-ESAT6 fusion protein H1 |
| 3 | Experimental | 50 ug H1 antigen in BCG immunized subjects Receives: Biological: Ag85B-ESAT6 fusion protein H1 |
| 4 | Experimental | 50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects Receives: Biological: Ag85B-ESAT6 fusion protein H1 |
| 5 | Experimental | 100 ug H1 antigen in BCG immunized subjects Receives: Biological: Ag85B-ESAT6 fusion protein H1 |
| 6 | Experimental | 100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects Receives: Biological: Ag85B-ESAT6 fusion protein H1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (1)
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionFeb 2008
Why it stopped: Safety Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, Novartis Vaccines, European Union
- Investigators
- David JM Lewis, MD, Principal investigator, St George's, University of London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440544
- Sponsor's protocol ID
- TMUVA-01
- Other IDs
- EudraCT Number: 2005-005140-81, FP6-2002-LIFESCIHEA-2.3 503240
- Acronym
- TMUVA-01
- Status last verified
- Oct 2008
- First submitted
- 26 Feb 2007
- Last updated
- 3 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the Safety and Immunogenicity of an Adjuvated TB Subunit Vaccine (Ag85B-ESAT6 + LTK63) Administered at 0 and 2 Months
- ClinicalTrials.gov ID
- NCT00440544
- Acronym / sponsor ID
- TMUVA-01 / TMUVA-01
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, vaccine, nasal immunization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety Issues
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Statens Serum Institut, Novartis Vaccines, European Union
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Ag85B-ESAT6 fusion protein H1100 ug H1 antigen alone in BCG naive subjects |
| 2 | Experimental | Biological: Ag85B-ESAT6 fusion protein H1100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects |
| 3 | Experimental | Biological: Ag85B-ESAT6 fusion protein H150 ug H1 antigen in BCG immunized subjects |
| 4 | Experimental | Biological: Ag85B-ESAT6 fusion protein H150 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects |
| 5 | Experimental | Biological: Ag85B-ESAT6 fusion protein H1100 ug H1 antigen in BCG immunized subjects |
| 6 | Experimental | Biological: Ag85B-ESAT6 fusion protein H1100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ag85B-ESAT6 fusion protein H1100 ug H1 antigen in BCG naive subjects | Biological | 1 |
| Ag85B-ESAT6 fusion protein H1100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects | Biological | 2 |
| Ag85B-ESAT6 fusion protein H150 ug H1 antigen in BCG immunized subjects | Biological | 3 |
| Ag85B-ESAT6 fusion protein H150 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects | Biological | 4 |
| Ag85B-ESAT6 fusion protein H1100 ug H1 antigen in BCG immunized subjects | Biological | 5 |
| Ag85B-ESAT6 fusion protein H1100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects | Biological | 6 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Safety Issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David JM Lewis, MD principal investigator
St George's, University of London, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ag85B-ESAT6 fusion protein H1 in people with Tuberculosis, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety Issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2008.