Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults

NCT01879163 | Completed Phase 1

• 1 other identifier: TB028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Tuberculosis (TB)

Keywords

Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Safety evaluation through actively and passively collected data on adverse events

  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.

  Up to 24 weeks

Secondary Outcomes (1)

• Evaluation of immune response of MVA85A-IMX313 vaccination compared with MVA85A vaccination in healthy, BCG vaccinated adults.

  Up to 24 weeks

Study Arms (3)

Group A

EXPERIMENTAL

The first six volunteers will receive an intradermal injection of 1x10\^7 pfu MVA85A-IMX313 (non-randomised).

Biological: MVA85A-IMX313

Group B

ACTIVE COMPARATOR

12 subjects receiving intradermal injection of 5x10\^7 pfu MVA85A-IMX313 (following completion of group A, subjects will be randomised to either group B or group C).

Biological: MVA85A-IMX313

Group C

ACTIVE COMPARATOR

12 subjects receiving intradermal injection of 5x10\^7 pfu MVA85A (following completion of group A, subjects will be randomised to either group B or group C).

Biological: MVA85A

Interventions

MVA85A-IMX313 BIOLOGICAL

Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313)

Group A; Group B

MVA85A BIOLOGICAL

Intradermal injection of MVA85A (recombinant Modified Vaccinia virus Ankara expressing the M. tb antigen 85A)

Also known as: AERAS-485

Group C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Able and willing (in the Investigator's opinion) to comply with all the trial requirements

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oxford: lead
• Imaxio: collaborator

Study Sites (2)

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Wellcome Trust Clinical Research Facility

Birmingham, B15 2TH, United Kingdom

Location

Related Publications (1)

• Minhinnick A, Satti I, Harris S, Wilkie M, Sheehan S, Stockdale L, Manjaly Thomas ZR, Lopez-Ramon R, Poulton I, Lawrie A, Vermaak S, Le Vert A, Del Campo J, Hill F, Moss P, McShane H. A first-in-human phase 1 trial to evaluate the safety and immunogenicity of the candidate tuberculosis vaccine MVA85A-IMX313, administered to BCG-vaccinated adults. Vaccine. 2016 Mar 8;34(11):1412-21. doi: 10.1016/j.vaccine.2016.01.062. Epub 2016 Feb 5.

  PMID: 26854906 DERIVED

Related Links

• Jenner Institute, University of Oxford, Website

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Helen McShane

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 17, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

GB (2)