- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01879163
Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults
December 15, 2014 updated by: University of Oxford
A Phase I Randomised Trial to Evaluate the Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in Bacille Calmette-Guérin (BCG) Vaccinated Adults
This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Birmingham, United Kingdom, B15 2TH
- Wellcome Trust Clinical Research Facility
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 7LE
- Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 vaccination 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)
- 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
Exclusion Criteria:
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
- 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), autoimmune disease, cancer (except BCC or CIS), cardiovascular disease, respiratory 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
The first six volunteers will receive an intradermal injection of 1x10^7 pfu MVA85A-IMX313 (non-randomised).
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Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313)
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Active Comparator: Group B
12 subjects receiving intradermal injection of 5x10^7 pfu MVA85A-IMX313 (following completion of group A, subjects will be randomised to either group B or group C).
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Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313)
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Active Comparator: Group C
12 subjects receiving intradermal injection of 5x10^7 pfu MVA85A (following completion of group A, subjects will be randomised to either group B or group C).
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Intradermal injection of MVA85A (recombinant Modified Vaccinia virus Ankara expressing the M. tb antigen 85A)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety evaluation through actively and passively collected data on adverse events
Time Frame: Up to 24 weeks
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To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A-IMX313 vaccination compared to MVA85A vaccination, by actively and passively collecting data on adverse events.
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Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of immune response of MVA85A-IMX313 vaccination compared with MVA85A vaccination in healthy, BCG vaccinated adults.
Time Frame: Up to 24 weeks
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To evaluate the immune response in healthy BCG-vaccinated subjects of MVA85A-IMX313 vaccination, compared with MVA85A vaccination, by comparing laboratory markers of cell mediated immunity in blood.
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Up to 24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
June 12, 2013
First Submitted That Met QC Criteria
June 12, 2013
First Posted (Estimate)
June 17, 2013
Study Record Updates
Last Update Posted (Estimate)
December 16, 2014
Last Update Submitted That Met QC Criteria
December 15, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TB028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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