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

Phase 1

Terminated

• Conditions: Tuberculosis
• Interventions: Biological: Aerosol inhaled MVA85A; Biological: Intramuscular MVA85A; Biological: Intramuscular Saline placebo; Biological: Aerosol inhaled Saline placebo

• Registration Number: NCT02532036
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-25
• Study Start: 2015-09
• Primary Completion: 2018-10-04
• Study Completion: 2018-10-04
• Status Verified: 2018-11
• Results First Submitted: 2020-08-14
• Results First Submitted QC: 2020-08-14
• Last Update Submitted: 2020-08-14
• Results First Posted: 2020-08-31
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Aerosol inhaled MVA85A	Receive 5x10\^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0.
Starter Group	Aerosol inhaled MVA85A	Receive 1x10\^7 pfu aerosol inhaled MVA85A at day 0.
Group A	Intramuscular Saline placebo	Receive 5x10\^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0.
Group B	Intramuscular MVA85A	Receive 5x10\^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0.
Group B	Aerosol inhaled Saline placebo	Receive 5x10\^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0.

Primary Outcome Measures

Name	Time	Method
Adverse Events (AE)	Up to Day 168	Actively and passively collected data on adverse events via diary card for 14 days after vaccination and at each visit over 6 months.

Secondary Outcome Measures

Name	Time	Method
Laboratory Markers of Immunity	Up to Day 168	Evaluation of ex-vivo ELISpot and intracellular cytokine staining in blood and bronchoalveolar lavage (BAL) samples.

Trial Locations

Locations (5)

NIHR/Wellcome Trust King's Clinical Research Facility; 🇬🇧 London, United Kingdom

Royal Free Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom

John Warin Ward, Churchill Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom

NIHR Wellcome Trust Clinical Research Facility, University of Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom