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

NCT02532036 | Terminated Phase 1 Results

• 1 other identifier: TB040
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

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.

Conditions

Tuberculosis

Keywords

MVA85A; Tuberculosis; Vaccine; Aerosol

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  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 Outcomes (1)

• Laboratory Markers of Immunity

  Up to Day 168

Study Arms (3)

Starter Group

EXPERIMENTAL

Receive 1x10\^7 pfu aerosol inhaled MVA85A at day 0.

Biological: Aerosol inhaled MVA85A

Group A

EXPERIMENTAL

Receive 5x10\^7 pfu aerosol inhaled MVA85A, and intramuscular saline placebo both at day 0.

Biological: Aerosol inhaled MVA85A; Biological: Intramuscular Saline placebo

Group B

EXPERIMENTAL

Receive 5x10\^7 pfu intramuscular MVA85A, and aerosol inhaled saline placebo both at day 0.

Biological: Intramuscular MVA85A; Biological: Aerosol inhaled Saline placebo

Interventions

Aerosol inhaled MVA85A BIOLOGICAL

Also known as: MVA85A

Group A; Starter Group

Intramuscular MVA85A BIOLOGICAL

Also known as: MVA85A

Group B

Intramuscular Saline placebo BIOLOGICAL

Also known as: Saline

Group A

Aerosol inhaled Saline placebo BIOLOGICAL

Also known as: Saline

Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• University of Birmingham: collaborator

Study Sites (5)

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

John Warin Ward, Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

NIHR Wellcome Trust Clinical Research Facility, University of Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

NIHR/Wellcome Trust King's Clinical Research Facility

London, United Kingdom

Location

Royal Free Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A; Sodium Chloride

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Due to significant challenges with recruitment at all UK sites this study has been terminated early.

Results Point of Contact

• Title: Professor Helen McShane
• Organization: University of Oxford

helen.mcshane@ndm.ox.ac.uk

+44 (0)1865 617606

Study Officials

• Helen McShane

  University of Oxford

  STUDY DIRECTOR

• Paul Moss

  University of Birmingham

  PRINCIPAL INVESTIGATOR

• Marc Lipman

  Royal Free Hostpital

  PRINCIPAL INVESTIGATOR

• Felicity Perrin

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 25, 2015
• Study Start: September 1, 2015
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: August 31, 2020
• Results First Posted: August 31, 2020

Record last verified: 2018-11

Locations

GB (5)