Tuberculosis (TB)Phase 1NCT00730795
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults
A Phase 1 study testing GSK's candidate Mycobacterium tuberculosis vaccine 692342 in people with Tuberculosis (TB), run by GlaxoSmithKline at 1 site in United States.
Trial summary
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- GSK's candidate Mycobacterium tuberculosis vaccine 692342
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2004
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between 18 and 40 years of age at the time of screening
- Negative PPD skin test at screening.
- Subjects must have chest X-ray showing no evidence of pulmonary pathology.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening, must not be breast-feeding and are required to use adequate contraception from enrolment till 1 month after dose 3.
- Screening laboratory values must be within the laboratory normal ranges.
- Negative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
Show all 9Show fewer
- Subjects must give written informed consent.
- Subjects must be willing to make all evaluation visits, be readily reachable by telephone or personal contact by the study site personnel and have a permanent address.
- Subjects' resting seated vital signs must be within the protocol-defined ranges.
Who cannot join
- History of prior Bacillus Calmette-Guérin (BCG) vaccinations.
- History of documented exposure to Mycobacterium tuberculosis.
- History of previous administration of experimental Mycobacterium tuberculosis vaccines or previous exposure to experimental products containing components of the experimental vaccine.
- History of employment in a healthcare facility in a capacity that had direct or indirect contact with TB patients.
- Administration of any immunoglobulins or any immunotherapy within the 3 months preceding the first dose of study vaccination, and/or any blood products within the 4 months preceding HIV screening, or planned administrations during the study period.
- Use of St. John's Wort within six months of the Day 0 visit or planned administrations during the study period.
Show all 19Show fewer
- Participation in another experimental protocol and/or receipt of any investigational products within 30 days prior to Day 0.
- History of autoimmune disease or causes of immunosuppressive states.
- 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.
- History of significant psychiatric illness.
- Current drug or alcohol abuse
- History of previous anaphylaxis or severe allergic reaction to vaccines or any other allergen.
- Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.
- Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements (including mineral preparations such as calcium carbonate), herbal medications except St. John's Wort, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (e.g. aspirin, ibuprofen), and acetominophen.
- Chronic administration (defined as more than 14 days total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.
- History of chronic or intermittently recurring illnesses such as migraine headaches, diabetes, heart disease, and asthma.
- Current administration of anti-TB prophylaxis or therapy.
- History of administration of a live attenuated virus vaccine within 30 days of enrollment.
- History of administration of a subunit or killed vaccine within 14 days of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Clinical Trials Call Center
Tacoma, Washington, 9843
About this study
Official title: A Phase I Open Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine, Mtb72F With AS02A Adjuvant, When Administered Intramuscularly to Healthy PPD-Negative Adults
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
- Conditions
- Tuberculosis (TB)
- Being tested
- GSK's candidate Mycobacterium tuberculosis vaccine 692342
- Keywords
- Tuberculosis vaccine
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK's candidate Mycobacterium tuberculosis vaccine 692342Biological
Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects receiving the low-dose antigen candidate TB vaccine Receives: Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342 |
| Group B | Experimental | Subjects receiving the high-dose antigen candidate TB vaccine Receives: Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicity
Measured: From study start up to Day 56.
Occurrence of serious adverse events
Measured: During the entire study period.
Occurrence of adverse events
Measured: At each visit
Laboratory measurements of serum chemistry and hematology
Measured: At study start, prior to each vaccination and 1 and 6 months after dose 3
Resting vital signs (blood pressure, pulse, temperature)
Measured: At study start, prior to each vaccination and 1 and 6 months after dose 3
Chest X-ray findings
Measured: At study start and study end
Secondary outcomes (2)
Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains.
Measured: Prior to each vaccination and 1 and 6 months after dose 3
Evaluation of PPD skin reactivity
Measured: At study start and study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Corixa Corporation
- Investigators
- Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730795
- Sponsor's protocol ID
- 692342/001
- Other IDs
- CCTB001-01
- Status last verified
- Aug 2008
- First submitted
- 7 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
Publications
Von Eschen K, Morrison R, Braun M, Ofori-Anyinam O, De Kock E, Pavithran P, Koutsoukos M, Moris P, Cain D, Dubois MC, Cohen J, Ballou WR. The candidate tuberculosis vaccine Mtb72F/AS02A: Tolerability and immunogenicity in humans. Hum Vaccin. 2009 Jul;5(7):475-82. doi: 10.4161/hv.8570. Epub 2009 Jul 27.
PubMed 19587528
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine, Mtb72F With AS02A Adjuvant, When Administered Intramuscularly to Healthy PPD-Negative Adults
- ClinicalTrials.gov ID
- NCT00730795
- Acronym / sponsor ID
- 692342/001
- Conditions
- Tuberculosis (TB)
- Keywords
- Tuberculosis vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Corixa Corporation
- Study start
- Jan 2004
- Primary completion
- Dec 2004 (actual)
- First posted
- 8 Aug 2008 (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.
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342Subjects receiving the low-dose antigen candidate TB vaccine |
| Group B | Experimental | Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342Subjects receiving the high-dose antigen candidate TB vaccine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female between 18 and 40 years of age at the time of screening
- Negative PPD skin test at screening.
- Subjects must have chest X-ray showing no evidence of pulmonary pathology.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening, must not be breast-feeding and are required to use adequate contraception from enrolment till 1 month after dose 3.
- Screening laboratory values must be within the laboratory normal ranges.
Key exclusion criteria (19 listed)
- History of prior Bacillus Calmette-Guérin (BCG) vaccinations.
- History of documented exposure to Mycobacterium tuberculosis.
- History of previous administration of experimental Mycobacterium tuberculosis vaccines or previous exposure to experimental products containing components of the experimental vaccine.
- History of employment in a healthcare facility in a capacity that had direct or indirect contact with TB patients.
- Administration of any immunoglobulins or any immunotherapy within the 3 months preceding the first dose of study vaccination, and/or any blood products within the 4 months preceding HIV screening, or planned administrations during the study period.
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 |
|---|---|---|
| GSK's candidate Mycobacterium tuberculosis vaccine 692342Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high) | Biological | Group A, Group B |
Primary outcome
Occurrence of dose limiting toxicity
Time frame: From study start up to Day 56.
Occurrence of serious adverse events
Time frame: During the entire study period.
Occurrence of adverse events
Time frame: At each visit
Laboratory measurements of serum chemistry and hematology
Time frame: At study start, prior to each vaccination and 1 and 6 months after dose 3
Resting vital signs (blood pressure, pulse, temperature)
Time frame: At study start, prior to each vaccination and 1 and 6 months after dose 3
Chest X-ray findings
Time frame: At study start and study end
2 secondary outcomes
Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains.
Time frame: Prior to each vaccination and 1 and 6 months after dose 3
Evaluation of PPD skin reactivity
Time frame: At study start and study end
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 8 Aug 2008.
- Derived from this study: PubMed 19587528Von Eschen K, Morrison R, Braun M, Ofori-Anyinam O, De Kock E, Pavithran P, Koutsoukos M, Moris P, Cain D, Dubois MC, Cohen J, Ballou WR. The candidate tuberculosis vaccine Mtb72F/AS02A: Tolerability and immunogenicity in humans. Hum Vaccin. 2009 Jul;5(7):475-82. doi: 10.4161/hv.8570. Epub 2009 Jul 27.
Related trials for Tuberculosis (TB)
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
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.
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 GSK's candidate Mycobacterium tuberculosis vaccine 692342 in people with Tuberculosis (TB), run by GlaxoSmithKline at 1 site in United States.
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 9 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: finished, as of the sponsor's last update on 8 Aug 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 States. 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 dose limiting toxicity (time frame: From study start up to Day 56.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00730795, which also lists 1 linked publication.
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 8 Aug 2008.