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Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults

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ClinicalTrials.gov Identifier: NCT01879163
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : December 16, 2014
Sponsor:
Collaborator:
Imaxio
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.

Condition or disease Intervention/treatment Phase
Tuberculosis (TB) Biological: MVA85A-IMX313 Biological: MVA85A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Phase I Randomised Trial to Evaluate the Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in Bacille Calmette-Guérin (BCG) Vaccinated Adults
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Group A
The first six volunteers will receive an intradermal injection of 1x10^7 pfu MVA85A-IMX313 (non-randomised).
Biological: MVA85A-IMX313
Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313)

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).
Biological: MVA85A-IMX313
Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313)

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).
Biological: MVA85A
Intradermal injection of MVA85A (recombinant Modified Vaccinia virus Ankara expressing the M. tb antigen 85A)
Other Name: AERAS-485




Primary Outcome Measures :
  1. Safety evaluation through actively and passively collected data on adverse events [ Time Frame: Up to 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Evaluation of immune response of MVA85A-IMX313 vaccination compared with MVA85A vaccination in healthy, BCG vaccinated adults. [ Time Frame: Up to 24 weeks ]
    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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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879163


Locations
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United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Wellcome Trust Clinical Research Facility
Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
University of Oxford
Imaxio
Investigators
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Principal Investigator: Helen McShane University of Oxford
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01879163    
Other Study ID Numbers: TB028
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by University of Oxford:
Vaccine
Immunogenicity
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections