A Phase I Randomised Trial to Evaluate the Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in Bacille Calmette-Guérin (BCG) Vaccinated Adults

University of Oxford2 sites in 1 country30 target enrollmentJuly 2013

ConditionsTuberculosis (TB)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Tuberculosis (TB)
Sponsor: University of Oxford
Enrollment: 30
Locations: 2
Primary Endpoint: Safety evaluation through actively and passively collected data on adverse events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following criteria to enter the trial:
•Healthy adult aged 18-55 years
•Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF) and able to travel to Oxford for vaccination 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

Exclusion Criteria

•Subjects must meet none of the following criteria to enter the trial:
•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), autoimmune disease, cancer (except BCC or CIS), cardiovascular disease, respiratory 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, including eggs
•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

Outcomes

Primary Outcomes

Safety evaluation through actively and passively collected data on adverse events

Time Frame: Up to 24 weeks

To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A-IMX313 vaccination compared to MVA85A vaccination, by actively and passively collecting data on adverse events.