TuberculosisPhase 1NCT01829490
Safety Study of ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy Adults
A Phase 1 study testing ChAdOx1 85A and MVA85A in people with Tuberculosis, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults. 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?
- ChAdOx1 85A and MVA85A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2013to Apr 2016
- 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
- Subjects must meet all of the following criteria to enter the trial:
- Healthy adult aged 18-55 years
- Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF) and able to travel to Oxford for vaccinations 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
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- 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 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
- Subjects must meet none of the following criteria to enter the trial:
- 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
- Shared a residence within one year prior to day 0 with an individual on anti-tuberculosis treatment or with culture- or smear-positive pulmonary tuberculosis
- Previous vaccination with any recombinant MVA, FP or adenoviral vector
- 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
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- 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 including eggs
- 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 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
2 sites in 1 country.
United Kingdom2 sites
The NIHR/ Wellcome Trust Clinical Research Facility, University of Birmingham
Birmingham, West Midlands, B15 2TB
Centre for Clinical Vaccinology and Tropical Medicine , University of Oxford
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Phase I Trial to Evaluate the Safety and Immunogenicity of a ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy BCG Vaccinated Adults
This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults.
- Conditions
- Tuberculosis
- Being tested
- ChAdOx1 85A, 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.
ChAdOx1 85ABiological
Intramuscular injection
MVA85ABiological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Starter Group | Experimental | The first six volunteers will receive one dose of 5x10^9vp of ChAdOx1 85A intramuscular injection. Receives: Biological: ChAdOx1 85A |
| Group A | Experimental | 12 subjects will receive one dose of 2.5x10^10vp of ChAdOx1 85A intramuscular injection. Receives: Biological: ChAdOx1 85A |
| Group B | Experimental | 12 subjects will receive one dose of 2.5x10^10vp of ChAdOx1 85A by intramuscular injection, followed by a boost dose of 1x10^8pfu of MVA85A by intramuscular injection 56 days later. Receives: Biological: ChAdOx1 85A; Biological: MVA85A |
| Group C | Experimental | 12 subjects will receive two doses of 2.5x10^10vp of ChAdOx1 85A by intramuscular injection at day 0 and day 28, followed by a boost dose of 1x10^8pfu of MVA85A by intramuscular injection at day 119. Receives: Biological: ChAdOx1 85A; Biological: MVA85A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults.
To evaluate the safety in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, with and without MVA85A boost vaccination, by actively and passively collecting data on adverse events.
Measured: Six months following vaccination
Secondary outcomes (1)
To investigate the T-cell immune response of ChAdOx1 85A vaccination compared with ChAdOx1 85A vaccination with MVA85A boost vaccination.
To evaluate the systemic and mucosal cellular immunogenicity in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, compared with ChAdOx1 85A vaccination with MVA85A boost vaccination, by comparing laboratory markers of cell mediated immunity in blood.
Measured: Six months following vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2016
- Study completionApr 2016
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
- None (open label)
- Enrolment
- 42 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, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829490
- Sponsor's protocol ID
- TB034
- Status last verified
- May 2016
- First submitted
- 26 Mar 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crisan-Dabija R, Grigorescu C, Pavel CA, Artene B, Popa IV, Cernomaz A, Burlacu A. Tuberculosis and COVID-19: Lessons from the Past Viral Outbreaks and Possible Future Outcomes. Can Respir J. 2020 Sep 5;2020:1401053. doi: 10.1155/2020/1401053. eCollection 2020.
PubMed 32934758
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial to Evaluate the Safety and Immunogenicity of a ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy BCG Vaccinated Adults
- ClinicalTrials.gov ID
- NCT01829490
- Acronym / sponsor ID
- TB034
- Conditions
- Tuberculosis
- Keywords
- Vaccine, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- Jul 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Apr 2013 (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 evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Starter Group | Experimental | Biological: ChAdOx1 85AThe first six volunteers will receive one dose of 5x10^9vp of ChAdOx1 85A intramuscular injection. |
| Group A | Experimental | Biological: ChAdOx1 85A12 subjects will receive one dose of 2.5x10^10vp of ChAdOx1 85A intramuscular injection. |
| Group B | Experimental | Biological: ChAdOx1 85A, Biological: MVA85A12 subjects will receive one dose of 2.5x10^10vp of ChAdOx1 85A by intramuscular injection, followed by a boost dose of 1x10^8pfu of MVA85A by intramuscular injection 56 days later. |
| Group C | Experimental | Biological: ChAdOx1 85A, Biological: MVA85A12 subjects will receive two doses of 2.5x10^10vp of ChAdOx1 85A by intramuscular injection at day 0 and day 28, followed by a boost dose of 1x10^8pfu of MVA85A by intramuscular injection at day 119. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy adult aged 18-55 years
- Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF) and able to travel to Oxford for vaccinations 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 (15 listed)
- 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
- Shared a residence within one year prior to day 0 with an individual on anti-tuberculosis treatment or with culture- or smear-positive pulmonary tuberculosis
- Previous vaccination with any recombinant MVA, FP or adenoviral vector
- 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
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 |
|---|---|---|
| ChAdOx1 85AIntramuscular injection | Biological | Group A, Group B, Group C, Starter Group |
| MVA85AIntramuscular injection | Biological | Group B, Group C |
Primary outcome
Safety of ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults.
Time frame: Six months following vaccination
To evaluate the safety in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, with and without MVA85A boost vaccination, by actively and passively collecting data on adverse events.
1 secondary outcome
To investigate the T-cell immune response of ChAdOx1 85A vaccination compared with ChAdOx1 85A vaccination with MVA85A boost vaccination.
Time frame: Six months 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 12 May 2016.
- Derived from this study: PubMed 32934758Crisan-Dabija R, Grigorescu C, Pavel CA, Artene B, Popa IV, Cernomaz A, Burlacu A. Tuberculosis and COVID-19: Lessons from the Past Viral Outbreaks and Possible Future Outcomes. Can Respir J. 2020 Sep 5;2020:1401053. doi: 10.1155/2020/1401053. eCollection 2020.
- Jenner Institute Clinical TrialsLink provided by the sponsor.
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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
2 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 ChAdOx1 85A and MVA85A in people with Tuberculosis, run by University of Oxford at 2 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 11 inclusion and 15 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults. (time frame: Six months 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 NCT01829490, 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 12 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.