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MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection

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ClinicalTrials.gov Identifier: NCT02532036
Recruitment Status : Terminated (Poor recruitment)
First Posted : August 25, 2015
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
University of Oxford

August 18, 2015
August 25, 2015
November 8, 2018
September 2015
October 4, 2018   (Final data collection date for primary outcome measure)
Adverse events (AE) [ Time Frame: Up to Day 168 ]
Collection of AE data at each visit and via diary card after vaccination visit.
Same as current
Complete list of historical versions of study NCT02532036 on ClinicalTrials.gov Archive Site
Laboratory markers of immunity [ Time Frame: Up to Day 168 ]
Evaluation of ex-vivo ELISpot and intracellular cytokine staining in blood and bronchoalveolar lavage (BAL) samples.
Same as current
Transcriptomics analysis [ Time Frame: Up to Day 168 ]
Analysis of transcriptomics and exploratory markers of immunity in blood and BAL samples.
Same as current
 
MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection
A Phase I Trial to Compare the Safety and Immunogenicity of Candidate TB Vaccine MVA85A Administered by the Aerosol Inhaled Route and the Intramuscular Route in Healthy Adult Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Tuberculosis
  • Biological: Aerosol inhaled MVA85A
    Other Name: MVA85A
  • Biological: Intramuscular MVA85A
    Other Name: MVA85A
  • Biological: Intramuscular Saline placebo
    Other Name: Saline
  • Biological: Aerosol inhaled Saline placebo
    Other Name: Saline
  • Experimental: Starter Group
    Receive 1x10^7 pfu aerosol inhaled MVA85A at day 0.
    Intervention: Biological: Aerosol inhaled MVA85A
  • Experimental: Group A
    Receive 5x10^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0.
    Interventions:
    • Biological: Aerosol inhaled MVA85A
    • Biological: Intramuscular Saline placebo
  • Experimental: Group B
    Receive 5x10^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0.
    Interventions:
    • Biological: Intramuscular MVA85A
    • Biological: Aerosol inhaled Saline placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
30
October 4, 2018
October 4, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT02532036
TB040
No
Not Provided
Not Provided
University of Oxford
University of Oxford
University of Birmingham
Study Director: Helen McShane University of Oxford
Principal Investigator: Paul Moss University of Birmingham
Principal Investigator: Marc Lipman Royal Free Hostpital
Principal Investigator: Felicity Perrin King's College Hospital NHS Trust
University of Oxford
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP