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

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT01497769

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Biological: Aerosol inhaled MVA85A Biological: Intradermal MVA85A	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official 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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Aerosol inhaled MVA85A and intradermal saline placebo	Biological: Aerosol inhaled MVA85A Aerosol inhaled MVA85A 1 x 10^7 pfu and intradermal saline placebo
Experimental: Group 2 Intradermal MVA85A and inhaled aerosol saline placebo	Biological: Intradermal MVA85A Intradermal MVA85A 1 x 10^7 pfu and inhaled aerosol saline placebo

Arm

Intervention/Treatment

Experimental: Group 1

Aerosol inhaled MVA85A and intradermal saline placebo

Biological: Aerosol inhaled MVA85A

Aerosol inhaled MVA85A 1 x 10^7 pfu and intradermal saline placebo

Experimental: Group 2

Intradermal MVA85A and inhaled aerosol saline placebo

Biological: Intradermal MVA85A

Intradermal MVA85A 1 x 10^7 pfu and inhaled aerosol saline placebo

Outcome Measures

Primary Outcome Measures

Safety of MVA85A vaccination by the aerosol inhaled route [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

Secondary Outcome Measures

Immunogenicity of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route [24 weeks following vaccination]
To evaluate the systemic and mucosal cellular immunogenicity in healthy BCG-vaccinated subjects of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route by comparing laboratory markers of cell mediated immunity in blood and bronchoalveolar lavage samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital	Oxford		United Kingdom

Sponsors and Collaborators

University of Oxford

Investigators

Principal Investigator: Helen McShane, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oxford

ClinicalTrials.gov Identifier:

NCT01497769

Other Study ID Numbers:

TB026

First Posted:

Dec 22, 2011

Last Update Posted:

Jul 2, 2013

Last Verified:

Jul 1, 2013

Keywords provided by University of Oxford

vaccine

immunogenicity

Additional relevant MeSH terms:

Tuberculosis

Study Results

No Results Posted as of Jul 2, 2013