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

August 14, 2020 updated by: University of Oxford

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Royal Free Hospital NHS Foundation Trust
      • London, United Kingdom
        • NIHR/Wellcome Trust King's Clinical Research Facility
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • John Warin Ward, Churchill Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • NIHR Wellcome Trust Clinical Research Facility, University of Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Starter Group
Receive 1x10^7 pfu aerosol inhaled MVA85A at day 0.
Biological: Aerosol inhaled MVA85A
Other Names:
  • MVA85A
Experimental: Group A
Receive 5x10^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0.
Biological: Aerosol inhaled MVA85A
Other Names:
  • MVA85A
Biological: Intramuscular Saline placebo
Other Names:
  • Saline
Experimental: Group B
Receive 5x10^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0.
Biological: Intramuscular MVA85A
Other Names:
  • MVA85A
Biological: Aerosol inhaled Saline placebo
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AE)
Time Frame: 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.
Up to Day 168

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Day 168

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University of Birmingham

Investigators

  • Principal Investigator: Paul Moss, University of Birmingham
  • Principal Investigator: Marc Lipman, Royal Free Hostpital
  • Principal Investigator: Felicity Perrin, King's College Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 4, 2018

Study Completion (Actual)

October 4, 2018

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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