TuberculosisPhase 1NCT01683773
Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A
A Phase 1 study testing AERAS-402 and MVA85A in people with Tuberculosis, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. 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?
- AERAS-402 and MVA85A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2012to Aug 2014
- 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
- Agrees to avoid elective surgery for the duration of the trial
- Has a body mass index (BMI) between 18 and 33 (weight/height2) by nomogram
- 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 treatment for active or latent tuberculosis infection
- Received a TST within 90 days prior to day 0
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- Received a systemic antibiotic within 14 days prior to day 0
- Inability to discontinue daily medications other than the following during the trial: oral contraceptives, vitamins, nonprescription nutritional supplements, aspirin, antihistamines, antihypertensives, antidepressants, inhaled steroids, bronchodilators, and any other stable, regular medication not deemed to have an impact on safety or immunogenicity.
- Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any other recombinant MVA or adenoviral vaccine; AERAS-402; or any other investigational M. tb vaccine
- Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), autoimmune disease, 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, 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 triala
- 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
2 sites in 1 country.
United Kingdom2 sites
The Wellcome Trust Clinical Research Facility (WTCRF), University of Birmingham
Birmingham, West Midlands, B15 2TH
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 Followed by MVA85A in BCG Vaccinated Adults (TB032)
This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their ability to stimulate an immune response within the body. It is hoped that when these two vaccines are given in sequence, the combined immune response is even better than when each vaccine is used individually.
- Conditions
- Tuberculosis
- Being tested
- AERAS-402, MVA85A
- Keywords
- Tuberculosis, Phase I, MVA85A, AERAS-402
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AERAS-402Biological
Also called Ad35 TB-S
Intramuscular needle injection 1x10^11 vp
MVA85ABiological
Also called AERAS-485
Intradermal needle injection 1x10^8 pfu
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Two doses of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection) Receives: Biological: AERAS-402; Biological: MVA85A |
| Group B | Experimental | One dose of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection) Receives: Biological: AERAS-402; Biological: MVA85A |
| Group C | Experimental | Three doses of AERAS-402 (1x10^11 vp intramuscular injection) Receives: Biological: AERAS-402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of AERAS-402 followed by MVA85A
To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events
Measured: 3 months after final vaccination
Secondary outcomes (1)
Immunogenicity of AERAS-402 followed by MVA85A
To evaluate and compare the immune responses as described by flow cytometric intracellular cytokine staining, antibody serology, and Elispot assays of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults
Measured: 12-18 months after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2014
- Study completionAug 2014
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Aeras, Crucell Holland BV, Emergent BioSolutions, University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Helen McShane, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683773
- Sponsor's protocol ID
- TB032
- Status last verified
- Sep 2014
- First submitted
- 24 Aug 2012
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sheehan S, Harris SA, Satti I, Hokey DA, Dheenadhayalan V, Stockdale L, Manjaly Thomas ZR, Minhinnick A, Wilkie M, Vermaak S, Meyer J, O'Shea MK, Pau MG, Versteege I, Douoguih M, Hendriks J, Sadoff J, Landry B, Moss P, McShane H. A Phase I, Open-Label Trial, Evaluating the Safety and Immunogenicity of Candidate Tuberculosis Vaccines AERAS-402 and MVA85A, Administered by Prime-Boost Regime in BCG-Vaccinated Healthy Adults. PLoS One. 2015 Nov 3;10(11):e0141687. doi: 10.1371/journal.pone.0141687. eCollection 2015.
PubMed 26529238
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 Followed by MVA85A in BCG Vaccinated Adults (TB032)
- ClinicalTrials.gov ID
- NCT01683773
- Acronym / sponsor ID
- TB032
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Phase I, MVA85A, AERAS-402
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Aeras, Crucell Holland BV, Emergent BioSolutions, University of Birmingham
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Sep 2012 (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 trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their ability to stimulate an immune response within the body. It is hoped that when these two vaccines are given in sequence, the combined immune response is even better than when each vaccine is used individually.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: AERAS-402, Biological: MVA85ATwo doses of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection) |
| Group B | Experimental | Biological: AERAS-402, Biological: MVA85AOne dose of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection) |
| Group C | Experimental | Biological: AERAS-402Three doses of AERAS-402 (1x10^11 vp intramuscular injection) |
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 (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 (19 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 treatment for active or latent tuberculosis infection
- Received a TST within 90 days prior to day 0
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 |
|---|---|---|
| AERAS-402Also: Ad35 TB-SIntramuscular needle injection 1x10^11 vp | Biological | Group A, Group B, Group C |
| MVA85AAlso: AERAS-485Intradermal needle injection 1x10^8 pfu | Biological | Group A, Group B |
Primary outcome
Safety of AERAS-402 followed by MVA85A
Time frame: 3 months after final vaccination
To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events
1 secondary outcome
Immunogenicity of AERAS-402 followed by MVA85A
Time frame: 12-18 months after first 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 17 Sep 2014.
- Derived from this study: PubMed 26529238Sheehan S, Harris SA, Satti I, Hokey DA, Dheenadhayalan V, Stockdale L, Manjaly Thomas ZR, Minhinnick A, Wilkie M, Vermaak S, Meyer J, O'Shea MK, Pau MG, Versteege I, Douoguih M, Hendriks J, Sadoff J, Landry B, Moss P, McShane H. A Phase I, Open-Label Trial, Evaluating the Safety and Immunogenicity of Candidate Tuberculosis Vaccines AERAS-402 and MVA85A, Administered by Prime-Boost Regime in BCG-Vaccinated Healthy Adults. PLoS One. 2015 Nov 3;10(11):e0141687. doi: 10.1371/journal.pone.0141687. eCollection 2015.
- The 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 AERAS-402 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 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: finished, as of the sponsor's last update on 17 Sep 2014. 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 AERAS-402 followed by MVA85A (time frame: 3 months after final 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 NCT01683773, 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 17 Sep 2014.