TuberculosisPhase 1NCT01497769
Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal Route
A Phase 1 study testing Aerosol inhaled MVA85A and Intradermal MVA85A in people with Tuberculosis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Aerosol inhaled MVA85A and Intradermal MVA85A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Apr 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-50 years
- Resident in or near Oxford for the duration of the trial period
- No relevant findings in medical history or on physical examination
- Confirmation of prior vaccination with BCG not less than 6 months prior to projected trial vaccination date (by visible BCG scar on examination or written documentation)
- Allow the Investigators to discuss the individual's medical history with their GP
- Use effective contraception for the duration of the trial period (females only)
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- Refrain from blood donation during the trial
- Give written informed consent
- Allow the Investigator to register subject details with a confidential database 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
- Any respiratory disease, including asthma
- Current smoker
- Clinically significant abnormality on screening chest x rays
- 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
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- Laboratory evidence at screening of latent M.tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
- Clinical, radiological, or laboratory evidence of current active TB disease
- Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any other recombinant MVA vaccine
- Clinically significant history of skin disorder, allergy, 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
- History of serious psychiatric condition
- Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
- 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
- Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the subject in the trial
- Positive HBsAg, HCV or HIV antibodies
- Female currently lactating, confirmed pregnancy or intention to become pregnant during trial period
- Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the trial vaccine for 30 days prior to dosing with the trial vaccine, or planned use during the trial period
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the subject at risk or may influence the result of the trial or may affect the subject's ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital
Oxford
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 Intradermal Route in Healthy BCG-vaccinated Adult Subjects
This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.
- Conditions
- Tuberculosis
- Being tested
- Aerosol inhaled MVA85A, Intradermal MVA85A
- Keywords
- vaccine, immunogenicity
- 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
Aerosol inhaled MVA85A 1 x 10^7 pfu and intradermal saline placebo
Intradermal MVA85ABiological
Intradermal MVA85A 1 x 10^7 pfu and inhaled aerosol saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Aerosol inhaled MVA85A and intradermal saline placebo Receives: Biological: Aerosol inhaled MVA85A |
| Group 2 | Experimental | Intradermal MVA85A and inhaled aerosol saline placebo Receives: Biological: Intradermal MVA85A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MVA85A vaccination by the aerosol inhaled route
To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A vaccination by the aerosol inhaled route by actively and passively collecting data on adverse events
Measured: 24 weeks following vaccination
Secondary outcomes (1)
Immunogenicity of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route
To evaluate the systemic and mucosal cellular immunogenicity in healthy BCG-vaccinated subjects of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route by comparing laboratory markers of cell mediated immunity in blood and bronchoalveolar lavage samples
Measured: 24 weeks following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionApr 2013
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen McShane, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497769
- Sponsor's protocol ID
- TB026
- Status last verified
- Jul 2013
- First submitted
- 20 Dec 2011
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Satti I, Meyer J, Harris SA, Manjaly Thomas ZR, Griffiths K, Antrobus RD, Rowland R, Ramon RL, Smith M, Sheehan S, Bettinson H, McShane H. Safety and immunogenicity of a candidate tuberculosis vaccine MVA85A delivered by aerosol in BCG-vaccinated healthy adults: a phase 1, double-blind, randomised controlled trial. Lancet Infect Dis. 2014 Oct;14(10):939-46. doi: 10.1016/S1473-3099(14)70845-X. Epub 2014 Aug 20.
PubMed 25151225
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. 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 Intradermal Route in Healthy BCG-vaccinated Adult Subjects
- ClinicalTrials.gov ID
- NCT01497769
- Acronym / sponsor ID
- TB026
- Conditions
- Tuberculosis
- Keywords
- vaccine, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Dec 2011 (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 is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Aerosol inhaled MVA85AAerosol inhaled MVA85A and intradermal saline placebo |
| Group 2 | Experimental | Biological: Intradermal MVA85AIntradermal MVA85A and inhaled aerosol saline placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy adults aged 18-50 years
- Resident in or near Oxford for the duration of the trial period
- No relevant findings in medical history or on physical examination
- Confirmation of prior vaccination with BCG not less than 6 months prior to projected trial vaccination date (by visible BCG scar on examination or written documentation)
- Allow the Investigators to discuss the individual's medical history with their GP
Key exclusion criteria (19 listed)
- Any respiratory disease, including asthma
- Current smoker
- Clinically significant abnormality on screening chest x rays
- Clinically significant abnormality of pulmonary function tests
- Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
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 MVA85AAerosol inhaled MVA85A 1 x 10^7 pfu and intradermal saline placebo | Biological | Group 1 |
| Intradermal MVA85AIntradermal MVA85A 1 x 10^7 pfu and inhaled aerosol saline placebo | Biological | Group 2 |
Primary outcome
Safety of MVA85A vaccination by the aerosol inhaled route
Time frame: 24 weeks following vaccination
To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A vaccination by the aerosol inhaled route by actively and passively collecting data on adverse events
1 secondary outcome
Immunogenicity of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route
Time frame: 24 weeks following vaccination
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 2 Jul 2013.
- Derived from this study: PubMed 25151225Satti I, Meyer J, Harris SA, Manjaly Thomas ZR, Griffiths K, Antrobus RD, Rowland R, Ramon RL, Smith M, Sheehan S, Bettinson H, McShane H. Safety and immunogenicity of a candidate tuberculosis vaccine MVA85A delivered by aerosol in BCG-vaccinated healthy adults: a phase 1, double-blind, randomised controlled trial. Lancet Infect Dis. 2014 Oct;14(10):939-46. doi: 10.1016/S1473-3099(14)70845-X. Epub 2014 Aug 20.
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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 principal investigator
University of Oxford
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 Aerosol inhaled MVA85A and Intradermal MVA85A in people with Tuberculosis, run by University of Oxford 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: finished, as of the sponsor's last update on 2 Jul 2013. 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 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?
Safety of MVA85A vaccination by the aerosol inhaled route (time frame: 24 weeks following vaccination). 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 NCT01497769, 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 2 Jul 2013.