MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection
Condition: Tuberculosis
MeSH terms: Tuberculosis
Intervention: Aerosol inhaled MVA85A; Intramuscular MVA85A; Intramuscular Saline placebo; Aerosol inhaled Saline placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MVA85A; Tuberculosis; Vaccine; Aerosol

Summary:

      TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis
      (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route
      in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Volunteers must meet all of the following criteria to enter the trial:

          -  Healthy adult aged 18-55 years

          -  Resident in or near Oxford, Birmingham or London for the duration of the trial period

          -  Screening IGRA positive

          -  Ineligible for chemoprophylaxis for latent M.tb infection, declined prophylaxis or
             considered low risk due to distant contact history

          -  Chest Computed Tomography (CT) normal; or abnormal with features consistent with
             primary M.tb infection but no features suggestive of active disease

          -  No relevant findings in medical history or on physical examination

          -  Allow the Investigators to discuss the individual's medical history with their General
             Practitioner

          -  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 volunteer details with a confidential database (The
             Over-volunteering Protection Service) to prevent concurrent entry into clinical trials

          -  Able and willing (in the Investigator's opinion) to comply with all the trial
             requirements

        Exclusion Criteria:

        Volunteers must meet none of the following criteria to enter the trial:

          -  Participation in another research study involving receipt of an investigational
             product in the 30 days preceding enrolment, or planned use during the trial period

          -  Prior vaccination with candidate vaccine MVA85A, candidate vaccine FP85A,any other
             recombinant MVA vaccine or any other candidate TB vaccine

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the planned trial vaccination date

          -  Clinically significant history of skin disorder, allergy, atopy, 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

          -  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, sedative drugs, or any local or general anaesthetic
             agents

          -  Pregnancy, lactation or intention to become pregnant during trial period

          -  Any respiratory disease, including asthma

          -  Current smoker

          -  Clinically significant abnormality on screening CT thorax

          -  Clinically significant abnormality of pulmonary function tests

          -  Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy

          -  Current use of any medication taken through the nasal or inhaled route including
             cocaine or other recreational drugs

          -  Clinical, radiological, or laboratory evidence of current active TB disease

          -  Past treatment for TB disease

          -  Any clinically significant abnormality of screening blood or urine tests

          -  Positive HBsAg, HCV or HIV antibodies

          -  Any other significant disease, disorder, or finding, which, in the opinion of the
             Investigator, may either put the volunteer at risk, affect the volunteer's ability to
             participate in the trial or impair interpretation of the trial data