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Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT01683773
Collaborator
Aeras (Other), Crucell Holland BV (Industry), Emergent BioSolutions (Industry), University of Birmingham (Other)
40
Enrollment
2
Locations
3
Arms
23
Duration (Months)
20
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: AERAS-402
  • Biological: MVA85A
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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)
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Two doses of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)

Biological: AERAS-402
Intramuscular needle injection 1x10^11 vp
Other Names:
  • Ad35 TB-S

    • Biological: MVA85A
    Intradermal needle injection 1x10^8 pfu
    Other Names:
  • AERAS-485

    		•
    Experimental: Group B

    One dose of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)

    Biological: AERAS-402
    Intramuscular needle injection 1x10^11 vp
    Other Names:
  • Ad35 TB-S

    • Biological: MVA85A
    Intradermal needle injection 1x10^8 pfu
    Other Names:
  • AERAS-485

    		•
    Experimental: Group C

    Three doses of AERAS-402 (1x10^11 vp intramuscular injection)

    Biological: AERAS-402
    Intramuscular needle injection 1x10^11 vp
    Other Names:
  • Ad35 TB-S

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of AERAS-402 followed by MVA85A [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

    Secondary Outcome Measures

    1. Immunogenicity of AERAS-402 followed by MVA85A [12-18 months after first vaccination]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 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

    • 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

    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

    • 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

    • 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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital Oxford Oxfordshire United Kingdom OX3 7LE
    2 The Wellcome Trust Clinical Research Facility (WTCRF), University of Birmingham Birmingham West Midlands United Kingdom B15 2TH

    Sponsors and Collaborators

    • University of Oxford
    • Aeras
    • Crucell Holland BV
    • Emergent BioSolutions
    • University of Birmingham

    Investigators

    • Principal Investigator: Helen McShane, University of Oxford

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT01683773
    Other Study ID Numbers:
    • TB032
    First Posted:
    Sep 12, 2012
    Last Update Posted:
    Sep 17, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by University of Oxford
    Tuberculosis
    Phase I
    MVA85A
    AERAS-402
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Sep 17, 2014