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

University of Oxford1 site in 1 country24 target enrollmentSeptember 2011

ConditionsTuberculosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Tuberculosis
Sponsor: University of Oxford
Enrollment: 24
Locations: 1
Primary Endpoint: Safety of MVA85A vaccination by the aerosol inhaled route
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Safety of MVA85A vaccination by the aerosol inhaled route

Time Frame: 24 weeks following vaccination

To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A vaccination by the aerosol inhaled route by actively and passively collecting data on adverse events