TuberculosisPhase 1NCT02532036
MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection
A Phase 1 study testing Aerosol inhaled MVA85A and Intramuscular MVA85A in people with Tuberculosis, run by University of Oxford at 5 sites in United Kingdom.
Trial summary
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis. 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?
- Aerosol inhaled MVA85A and Intramuscular MVA85A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Sep 2015to 4 Oct 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Volunteers must meet all of the following criteria to enter the trial:
- Healthy adult aged 18-55 years
- Resident in or near Oxford, Birmingham or London for the duration of the trial period
- Screening IGRA positive
- Ineligible for chemoprophylaxis for latent M.tb infection, declined prophylaxis or considered low risk due to distant contact history
- Chest Computed Tomography (CT) normal; or abnormal with features consistent with primary M.tb infection but no features suggestive of active disease
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- No relevant findings in medical history or on physical examination
- Allow the Investigators to discuss the individual's medical history with their General Practitioner
- Use effective contraception for the duration of the trial period (females only)
- Refrain from blood donation during the trial
- Give written informed consent
- Allow the Investigator to register volunteer details with a confidential database (The Over-volunteering Protection Service) to prevent concurrent entry into clinical trials
- Able and willing (in the Investigator's opinion) to comply with all the trial requirements
Who cannot join
- Volunteers must meet none of the following criteria to enter the trial:
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the trial period
- Prior vaccination with candidate vaccine MVA85A, candidate vaccine FP85A,any other recombinant MVA vaccine or any other candidate TB vaccine
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
- Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
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- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine, sedative drugs, or any local or general anaesthetic agents
- Pregnancy, lactation or intention to become pregnant during trial period
- Any respiratory disease, including asthma
- Current smoker
- Clinically significant abnormality on screening CT thorax
- Clinically significant abnormality of pulmonary function tests
- Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
- Current use of any medication taken through the nasal or inhaled route including cocaine or other recreational drugs
- Clinical, radiological, or laboratory evidence of current active TB disease
- Past treatment for TB disease
- Any clinically significant abnormality of screening blood or urine tests
- Positive HBsAg, HCV or HIV antibodies
- Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the trial or impair interpretation of the trial data
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
NIHR Wellcome Trust Clinical Research Facility, University of Birmingham
Birmingham, West Midlands, B15 2TH
NIHR/Wellcome Trust King's Clinical Research Facility
London
Royal Free Hospital NHS Foundation Trust
London
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
John Warin Ward, Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Phase I Trial to Compare the Safety and Immunogenicity of Candidate TB Vaccine MVA85A Administered by the Aerosol Inhaled Route and the Intramuscular Route in Healthy Adult Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.
- Conditions
- Tuberculosis
- Being tested
- Aerosol inhaled MVA85A, Intramuscular MVA85A, Intramuscular Saline placebo, Aerosol inhaled Saline placebo
- Keywords
- MVA85A, Tuberculosis, Vaccine, Aerosol
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosol inhaled MVA85ABiological
Also called MVA85A
Intramuscular MVA85ABiological
Also called MVA85A
Intramuscular Saline placeboBiological
Also called Saline
Aerosol inhaled Saline placeboBiological
Also called Saline
| Study group | Role | What they receive |
|---|---|---|
| Starter Group | Experimental | Receive 1x10^7 pfu aerosol inhaled MVA85A at day 0. Receives: Biological: Aerosol inhaled MVA85A |
| Group A | Experimental | Receive 5x10^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0. Receives: Biological: Aerosol inhaled MVA85A; Biological: Intramuscular Saline placebo |
| Group B | Experimental | Receive 5x10^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0. Receives: Biological: Intramuscular MVA85A; Biological: Aerosol inhaled Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
Actively and passively collected data on adverse events via diary card for 14 days after vaccination and at each visit over 6 months.
Measured: Up to Day 168
Secondary outcomes (1)
Laboratory Markers of Immunity
Evaluation of ex-vivo ELISpot and intracellular cytokine staining in blood and bronchoalveolar lavage (BAL) samples.
Measured: Up to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Helen McShane, Study director, University of OxfordPaul Moss, Principal investigator, University of BirminghamMarc Lipman, Principal investigator, Royal Free HostpitalFelicity Perrin, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532036
- Sponsor's protocol ID
- TB040
- Status last verified
- Nov 2018
- First submitted
- 18 Aug 2015
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial to Compare the Safety and Immunogenicity of Candidate TB Vaccine MVA85A Administered by the Aerosol Inhaled Route and the Intramuscular Route in Healthy Adult Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis
- ClinicalTrials.gov ID
- NCT02532036
- Acronym / sponsor ID
- TB040
- Conditions
- Tuberculosis
- Keywords
- MVA85A, Tuberculosis, Vaccine, Aerosol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- Sep 2015
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Starter Group | Experimental | Biological: Aerosol inhaled MVA85AReceive 1x10^7 pfu aerosol inhaled MVA85A at day 0. |
| Group A | Experimental | Biological: Aerosol inhaled MVA85A, Biological: Intramuscular Saline placeboReceive 5x10^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0. |
| Group B | Experimental | Biological: Intramuscular MVA85A, Biological: Aerosol inhaled Saline placeboReceive 5x10^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy adult aged 18-55 years
- Resident in or near Oxford, Birmingham or London for the duration of the trial period
- Screening IGRA positive
- Ineligible for chemoprophylaxis for latent M.tb infection, declined prophylaxis or considered low risk due to distant contact history
- Chest Computed Tomography (CT) normal; or abnormal with features consistent with primary M.tb infection but no features suggestive of active disease
Key exclusion criteria (19 listed)
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the trial period
- Prior vaccination with candidate vaccine MVA85A, candidate vaccine FP85A,any other recombinant MVA vaccine or any other candidate TB vaccine
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
- Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
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 |
|---|---|---|
| Aerosol inhaled MVA85AAlso: MVA85A | Biological | Group A, Starter Group |
| Intramuscular MVA85AAlso: MVA85A | Biological | Group B |
| Intramuscular Saline placeboAlso: Saline | Biological | Group A |
| Aerosol inhaled Saline placeboAlso: Saline | Biological | Group B |
Primary outcome
Adverse Events (AE)
Time frame: Up to Day 168
Actively and passively collected data on adverse events via diary card for 14 days after vaccination and at each visit over 6 months.
1 secondary outcome
Laboratory Markers of Immunity
Time frame: Up to Day 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Helen McShane study director
University of Oxford
Paul Moss principal investigator
University of Birmingham
Marc Lipman principal investigator
Royal Free Hostpital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aerosol inhaled MVA85A and Intramuscular MVA85A in people with Tuberculosis, run by University of Oxford at 5 sites 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 13 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (AE) (time frame: Up to Day 168). 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 31 Aug 2020.