Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal Route

University of Oxford

Status and phase

Completed

Phase 1

Conditions

Tuberculosis

Treatments

Biological: Aerosol inhaled MVA85A

Biological: Intradermal MVA85A

Study type

Interventional

Funder types

Other

Identifiers

NCT01497769

TB026

Details and patient eligibility

About

This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults aged 18-50 years
Resident in or near Oxford for the duration of the trial period
No relevant findings in medical history or on physical examination
Confirmation of prior vaccination with BCG not less than 6 months prior to projected trial vaccination date (by visible BCG scar on examination or written documentation)
Allow the Investigators to discuss the individual's medical history with their GP
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 subject details with a confidential database to prevent concurrent entry into clinical trials
Able and willing (in the Investigator's opinion) to comply with all the trial requirements

Exclusion criteria

Any respiratory disease, including asthma
Current smoker
Clinically significant abnormality on screening chest x rays
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
Laboratory evidence at screening of latent M.tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
Clinical, radiological, or laboratory evidence of current active TB disease
Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any other recombinant MVA vaccine
Clinically significant history of skin disorder, allergy, 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
History of serious psychiatric condition
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
Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the subject in the trial
Positive HBsAg, HCV or HIV antibodies
Female currently lactating, confirmed pregnancy or intention to become pregnant during trial period
Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the trial vaccine for 30 days prior to dosing with the trial vaccine, or planned use during the trial period
Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the subject at risk or may influence the result of the trial or may affect the subject's ability to participate in the trial