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

NCT01497769 | Completed Phase 1 DMC

• 1 other identifier: TB026
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

vaccine; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Safety of MVA85A vaccination by the aerosol inhaled route

  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

  24 weeks following vaccination

Secondary Outcomes (1)

• Immunogenicity of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route

  24 weeks following vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

Aerosol inhaled MVA85A and intradermal saline placebo

Biological: Aerosol inhaled MVA85A

Group 2

EXPERIMENTAL

Intradermal MVA85A and inhaled aerosol saline placebo

Biological: Intradermal MVA85A

Interventions

Aerosol inhaled MVA85A BIOLOGICAL

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

Group 1

Intradermal MVA85A BIOLOGICAL

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

Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital

Oxford, United Kingdom

Location

Related Publications (1)

• Satti I, Meyer J, Harris SA, Manjaly Thomas ZR, Griffiths K, Antrobus RD, Rowland R, Ramon RL, Smith M, Sheehan S, Bettinson H, McShane H. Safety and immunogenicity of a candidate tuberculosis vaccine MVA85A delivered by aerosol in BCG-vaccinated healthy adults: a phase 1, double-blind, randomised controlled trial. Lancet Infect Dis. 2014 Oct;14(10):939-46. doi: 10.1016/S1473-3099(14)70845-X. Epub 2014 Aug 20.

  PMID: 25151225 DERIVED

MeSH Terms

Conditions

Tuberculosis

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: December 20, 2011
• First Posted: December 22, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: July 2, 2013

Record last verified: 2013-07

Locations

GB (1)