Tuberculosis (TB)Phase 1NCT00291889
Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.
A Phase 1 study testing Mtb72F/AS02. in people with Tuberculosis (TB), run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- Mtb72F/AS02.
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2004to May 2005
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Healthy PPD-negative volunteers aged 18 to 45 years
- No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
- Seronegative for HIV 1 and 2, HBsAg, and HCV
- Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
- Females : Non pregnant, must use adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Who cannot join
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- History of prior Bacillus Calmette-Guérin (BCG) vaccination.
- History of documented exposure to Mycobacterium tuberculosis
- History of prior vaccination with experimental Mycobacterium Tuberculosis vaccines or experimental products containing MPL or QS21.
- Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
- History of hypersensitivity to vaccines or vaccine components
- History of any acute or chronic illness or medication that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Safety, Reactogenicity & Immunogenicity of 2 Antigen Dose Levels of GSK Biologicals' Candidate Tuberculosis Vaccine, Mtb72F/AS02 to Healthy PPD-negative Volunteers Aged 18 to 45 Yrs
Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.
Read the detailed description
The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers will receive the vaccine alone without an immunostimulant and 1 control group will receive the adjuvant (AS02) alone to assess the true effect of the candidate tuberculosis vaccine (Mtb72F/AS02).
- Conditions
- Tuberculosis (TB)
- Being tested
- Mtb72F/AS02.
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mtb72F/AS02.Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study
Secondary outcomes (1)
Immunogenicity as assessed by humoral and CMI response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJul 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291889
- Sponsor's protocol ID
- 102039
- Status last verified
- May 2017
- First submitted
- 14 Feb 2006
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety, Reactogenicity & Immunogenicity of 2 Antigen Dose Levels of GSK Biologicals' Candidate Tuberculosis Vaccine, Mtb72F/AS02 to Healthy PPD-negative Volunteers Aged 18 to 45 Yrs
- ClinicalTrials.gov ID
- NCT00291889
- Acronym / sponsor ID
- 102039
- Conditions
- Tuberculosis (TB)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 15 Feb 2006 (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.
Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.
Detailed description
The safety and immunogenicity of 2 antigen doses in PPD-negative adults will be evaluated. In addition, 2 active comparator groups of volunteers will receive the vaccine alone without an immunostimulant and 1 control group will receive the adjuvant (AS02) alone to assess the true effect of the candidate tuberculosis vaccine (Mtb72F/AS02).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent
- Healthy PPD-negative volunteers aged 18 to 45 years
- No evidence of pulmonary pathology (i.e. acute or chronic pulmonary disease; past TB infection/disease) as confirmed by chest X-ray.
- Seronegative for HIV 1 and 2, HBsAg, and HCV
- Clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, complete blood count (CBC) and differential, haemoglobin, platelet count and urinalysis.
Key exclusion criteria (7 listed)
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- History of prior Bacillus Calmette-Guérin (BCG) vaccination.
- History of documented exposure to Mycobacterium tuberculosis
- History of prior vaccination with experimental Mycobacterium Tuberculosis vaccines or experimental products containing MPL or QS21.
- Any confirmed or suspected immunosuppressive or immunodeficient condition; or family history of congenital or hereditary immunodeficiency.
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 |
|---|---|---|
| Mtb72F/AS02. | Biological | – |
Primary outcome
Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study
1 secondary outcome
Immunogenicity as assessed by humoral and CMI response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Mtb72F/AS02. in people with Tuberculosis (TB), run by GlaxoSmithKline at 1 site in Belgium.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 30 May 2017. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study. 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 30 May 2017.