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

University of Oxford5 sites in 1 country2 target enrollmentSeptember 2015

ConditionsTuberculosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Tuberculosis
Sponsor: University of Oxford
Enrollment: 2
Locations: 5
Primary Endpoint: Adverse Events (AE)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

October 4, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

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

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