Clinical trial NCT02532036: MVA85A Aerosol vs Intramuscular Vaccination in Adults With Latent Mycobacterium Tuberculosis (M. tb) Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tuberculosis
Keywords: MVA85A
Tuberculosis
Vaccine
Aerosol
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2015-08-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Adverse Events (AE)
timeFrame: Up to Day 168
Secondary outcomes:
measure: Laboratory Markers of Immunity
timeFrame: Up to Day 168
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
state: Oxfordshire
city: Oxford
country: United Kingdom
facility: John Warin Ward, Churchill Hospital
state: Oxfordshire
city: Birmingham
country: United Kingdom
facility: NIHR Wellcome Trust Clinical Research Facility, University of Birmingham
state: West Midlands
city: London
country: United Kingdom
facility: NIHR/Wellcome Trust King's Clinical Research Facility
city: London
country: United Kingdom
facility: Royal Free Hospital NHS Foundation Trust
Study officials:
affiliation: University of Oxford
name: Helen McShane
role: STUDY_DIRECTOR
affiliation: University of Birmingham
name: Paul Moss
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Free Hostpital
name: Marc Lipman
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College Hospital NHS Trust
name: Felicity Perrin
role: PRINCIPAL_INVESTIGATOR
References: