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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Tuberculosis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01497769
Primary Trial ID Number
Summary
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.
Research Details
    Sorry, this information is not available
Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Study Type
Interventional
Intervention
Biological : Aerosol inhaled MVA85A, Biological : Intradermal MVA85A

Study Arm Groups : Group 1, Group 2

Intervention Type
See Interventions above
Primary Outcome Measures
  • Safety of MVA85A vaccination by the aerosol inhaled route; 24 weeks following vaccination
Secondary Outcome Measures
  • Immunogenicity of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route; 24 weeks following vaccination
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 50 Years
Who Can Participate
Sorry, this information is not available
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Oxford
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
TB026
Sponsor(s)
University of Oxford
Key Dates

Recruitment Start Date

Sep 2011

Recruitment End Date

Oct 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

20 Dec 2011

Last Updated

01 Jul 2013